A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 302
- 试验地点
- 104
- 主要终点
- Number of Participants With Laboratory Test Abnormalities
研究概览
简要总结
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
详细描述
This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.
Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.
For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.
The total duration of an individual subject's participation may vary depending upon when they enter the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
- •The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
- •Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
- •Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.
排除标准
- •persistent oligoarthritis, and undifferentiated JIA.
- •Infections:
- •Chronic infections.
- •Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
- •Any treated infections within 2 weeks of baseline visit.
- •A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- •History of infected joint prosthesis with prosthesis still in situ.
- •History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
研究组 & 干预措施
Tofacitinib
All patients will be in tofacitinib treatment group.
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Number of Participants With Laboratory Test Abnormalities
时间窗: During study treatment (maximum up to 118 months)
Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.
Absolute Values of Body Weight at Baseline
时间窗: At Baseline
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Number of Participants With Shift in Tanner Stage From Baseline to Month 12
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.
Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12
时间窗: Baseline, Month 12
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24
时间窗: Baseline, Month 24
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36
时间窗: Baseline, Month 36
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48
时间窗: Baseline, Month 48
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60
时间窗: Baseline, Month 60
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72
时间窗: Baseline, Month 72
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84
时间窗: Baseline, Month 84
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Baseline
时间窗: At Baseline
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12
时间窗: Baseline, Month 12
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24
时间窗: Baseline, Month 24
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36
时间窗: Baseline, Month 36
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48
时间窗: Baseline, Month 48
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60
时间窗: Baseline, Month 60
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72
时间窗: Baseline, Month 72
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84
时间窗: Baseline, Month 84
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).
Number of Participants According to Tanner Stage at Baseline
时间窗: At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)
Pubertal development was measured using Tanner stage, by age group (2 to \<6 years, 6 to \<12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).
Number of Participants With Shift in Tanner Stage From Baseline to Month 24
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 36
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 48
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 60
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 72
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 84
时间窗: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.
次要结局
- Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Systemic Juvenile Idiopathic Arthritis (sJIA) 1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Enthesitis Related Arthritis (ERA) Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Psoriatic Arthritis (PsA) Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA American College of Rheumatology 30 (ACR 30) Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(At Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78:Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and ESR Score at Months 1,3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78:Participants in pJIA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78)
- Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in sJIA1 Analysis Set(From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months))
- Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in sJIA2 Analysis Set(From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months))
- Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in pJIA Analysis Set(From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months))
- Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in ERA Analysis Set(From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months))
- Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in PsA Analysis Set(From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months))
- Percentage of Participants Who Achieved Absence of Fever 1 Week Prior to Assessment at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Percentage of Participants Who Achieved Absence of Fever 1 Week Prior to Assessment at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set(At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
- Change From Baseline in Tender Entheseal Assessment at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Modified Schober's Test at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Overall Back Pain at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Nocturnal Back Pain at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Body Surface Area (BSA) at Months 3, 6, 12, 18, 24, 30 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Physician's Global Assessment (PGA) at Months 3, 6, 12, 18, 24, 30 and 36: Participants in PsA Analysis Set(Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36)