Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 主要终点
- American College of Rheumatology (ACR) 20 Response Rate at Week 2
研究概览
简要总结
This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab 40 mg EOW given on background methotrexate.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-
- •If female, subject must meet one of the following criteria:
- •Postmenopausal (defined as no menses for at least 1 year).
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- •Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
- •Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
- •Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.
排除标准
- •Pregnant or breastfeeding female.
- •Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
- •Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
- •Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
- •Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.
研究组 & 干预措施
ABT-122 120 mg EOW
All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.
干预措施: ABT-122 (Drug)
结局指标
主要结局
American College of Rheumatology (ACR) 20 Response Rate at Week 2
时间窗: Week 2 of Study M12-963
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 4
时间窗: Week 4 of Study M12-963
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 6
时间窗: Week 6 of Study M12-963
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 8
时间窗: Week 8 of Study M12-963
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 12
时间窗: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 16
时间窗: Week 16 (Week 4 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 20
时间窗: Week 20 (Week 8 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 24
时间窗: Week 24 (Week 12 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 20
时间窗: Week 20 (Week 8 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 28
时间窗: Week 28 (Week 16 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 32
时间窗: Week 32 (Week 20 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR20 Response Rate at Week 36
时间窗: Week 36 (Week 24 of Study M12-965)
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 2
时间窗: Week 2 of Study M12-963
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 4
时间窗: Week 4 of Study M12-963
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 6
时间窗: Week 6 of Study M12-963
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 8
时间窗: Week 8 of Study M12-963
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 12
时间窗: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 16
时间窗: Week 16 (Week 4 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 24
时间窗: Week 24 (Week 12 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 28
时间窗: Week 28 (Week 16 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 32
时间窗: Week 32 (Week 20 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR50 Response Rate at Week 36
时间窗: Week 36 (Week 24 of Study M12-965)
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 2
时间窗: Week 2 of Study M12-963
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 4
时间窗: Week 4 of Study M12-963
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 6
时间窗: Week 6 of Study M12-963
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 8
时间窗: Week 8 of Study M12-963
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 16
时间窗: Week 16 (Week 4 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 12
时间窗: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 20
时间窗: Week 20 (Week 8 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 24
时间窗: Week 24 (Week 12 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 28
时间窗: Week 28 (Week 16 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 32
时间窗: Week 32 (Week 20 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
ACR70 Response Rate at Week 36
时间窗: Week 36 (Week 24 of Study M12-965)
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths
时间窗: from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
次要结局
- Change From Baseline In Tender Joint Count (TJC68) at Week 2(Week 2 of Study M12-963)
- Change From Baseline in TJC68 at Week 4(Week 4 of Study M12-963)
- Change From Baseline in TJC68 at Week 6(Week 6 of Study M12-963)
- Change From Baseline in TJC68 at Week 8(Week 8 of Study M12-963)
- Change From Baseline in TJC68 at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in TJC68 at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in SJC66 at Week 8(Week 8 of Study M12-963)
- Change From Baseline in SJC66 at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in SJC66 at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in TJC68 at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in TJC68 at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in TJC68 at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in TJC68 at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in TJC68 at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Swollen Joint Count (SJC66) at Week 2(Week 2 of Study M12-963)
- Change From Baseline in SJC66 at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in SJC66 at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in SJC66 at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in SJC66 at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in SJC66 at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 2(Week 2 of Study M12-963)
- Change From Baseline in SJC66 at Week 4(Week 4 of Study M12-963)
- Change From Baseline in SJC66 at Week 6(Week 6 of Study M12-963)
- Change From Baseline in Patient's Assessment of Pain at Week 4(Week 4 of Study M12-963)
- Change From Baseline in Patient's Assessment of Pain at Week 6(Week 6 of Study M12-963)
- Change From Baseline in Patient's Assessment of Pain at Week 8(Week 8 of Study M12-963)
- Change From Baseline in Patient's Assessment of Pain at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in Patient's Assessment of Pain at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2(Week 2 of Study M12-963)
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4(Week 4 of Study M12-963)
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6(Week 6 of Study M12-963)
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8(Week 8 of Study M12-963)
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2(Week 2 of Study M12-963)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4(Week 4 of Study M12-963)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6(Week 6 of Study M12-963)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8(Week 8 of Study M12-963)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2(Week 2 of Study M12-963)
- Change From Baseline in HAQ-DI at Week 4(Week 4 of Study M12-963)
- Change From Baseline in hsCRP at Week 8(Week 8 of Study M12-963)
- Change From Baseline in HAQ-DI at Week 6(Week 6 of Study M12-963)
- Change From Baseline in HAQ-DI at Week 8(Week 8 of Study M12-963)
- Change From Baseline in HAQ-DI at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in HAQ-DI at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in HAQ-DI at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in HAQ-DI at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in HAQ-DI at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in HAQ-DI at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in HAQ-DI at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2(Week 2 of Study M12-963)
- Change From Baseline in hsCRP at Week 4(Week 4 of Study M12-963)
- Change From Baseline in hsCRP at Week 6(Week 6 of Study M12-963)
- Change From Baseline in hsCRP at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in hsCRP at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in hsCRP at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in hsCRP at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in hsCRP at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in hsCRP at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in hsCRP at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2(Week 2 of Study M12-963)
- Change From Baseline in DAS28 (hsCRP) at Week 4(Week 4 of Study M12-963)
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8(Week 8 of Study M12-963)
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16(Week 16 (Week 4 of Study M12-965))
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in DAS28 (hsCRP) at Week 6(Week 6 of Study M12-963)
- Change From Baseline in DAS28 (hsCRP) at Week 8(Week 8 of Study M12-963)
- Change From Baseline in DAS28 (hsCRP) at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in CDAI at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in CDAI at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in CDAI at Week 36(Week 36 (Week 24 of Study M12-965))
- Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2(Week 2 of Study M12-963)
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4(Week 4 of Study M12-963)
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6(Week 6 of Study M12-963)
- Change From Baseline in DAS28 (hsCRP) at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in DAS28 (hsCRP) at Week 20(Week 20 (Week 8 of Study M12-965))
- Change From Baseline in DAS28 (hsCRP) at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in DAS28 (hsCRP) at Week 28(Week 28 (Week 16 of Study M12-965))
- Change From Baseline in DAS28 (hsCRP) at Week 32(Week 32 (Week 20 of Study M12-965))
- Change From Baseline in DAS28 (hsCRP) at Week 36(Week 36 (Week 24 of Study M12-965))
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2(Week 2 of Study M12-963)
- Change From Baseline in CDAI at Week 4(Week 4 of Study M12-963)
- Change From Baseline in CDAI at Week 6(Week 6 of Study M12-963)
- Change From Baseline in CDAI at Week 8(Week 8 of Study M12-963)
- Change From Baseline in CDAI at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- Change From Baseline in CDAI at Week 16(Week 16 (Week 4 of Study M12-965))
- Change From Baseline in CDAI at Week 24(Week 24 (Week 12 of Study M12-965))
- Change From Baseline in CDAI at Week 28(Week 28 (Week 16 of Study M12-965))
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24(Week 24 (Week 12 of Study M12-965))
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28(Week 28 (Week 16 of Study M12-965))
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32(Week 32 (Week 20 of Study M12-965))
- LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36(Week 36 (Week 24 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 2(Week 2 of Study M12-963)
- CR Response Rate Per DAS28 (hsCRP) at Week 4(Week 4 of Study M12-963)
- CR Response Rate Per DAS28 (hsCRP) at Week 6(Week 6 of Study M12-963)
- CR Response Rate Per DAS28 (hsCRP) at Week 8(Week 8 of Study M12-963)
- CR Response Rate Per DAS28 (hsCRP) at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 16(Week 16 (Week 4 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 20(Week 20 (Week 8 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 24(Week 24 (Week 12 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 28(Week 28 (Week 16 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 32(Week 32 (Week 20 of Study M12-965))
- CR Response Rate Per DAS28 (hsCRP) at Week 36(Week 36 (Week 24 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 2(Week 2 of Study M12-963)
- LDA or CR Response Rate Per CDAI at Week 4(Week 4 of Study M12-963)
- LDA or CR Response Rate Per CDAI at Week 6(Week 6 of Study M12-963)
- LDA or CR Response Rate Per CDAI at Week 8(Week 8 of Study M12-963)
- LDA or CR Response Rate Per CDAI at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 16(Week 16 (Week 4 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 20(Week 20 (Week 8 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 24(Week 24 (Week 12 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 28(Week 28 (Week 16 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 32(Week 32 (Week 20 of Study M12-965))
- LDA or CR Response Rate Per CDAI at Week 36(Week 36 (Week 24 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 2(Week 2 of Study M12-963)
- CR Response Rate Per CDAI Criteria at Week 4(Week 4 of Study M12-963)
- CR Response Rate Per CDAI Criteria at Week 6(Week 6 of Study M12-963)
- CR Response Rate Per CDAI Criteria at Week 8(Week 8 of Study M12-963)
- CR Response Rate Per CDAI Criteria at Week 12(Week 12 of Study M12-963 (considered Week 0 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 16(Week 16 (Week 4 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 20(Week 20 (Week 8 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 24(Week 24 (Week 12 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 28(Week 28 (Week 16 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 32(Week 32 (Week 20 of Study M12-965))
- CR Response Rate Per CDAI Criteria at Week 36(Week 36 (Week 24 of Study M12-965))