A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,534
- 试验地点
- 180
- 主要终点
- Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12
研究概览
简要总结
The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of RA, axSpA, PsA or PsO
- •No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.
排除标准
- •The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
- •The additional documentation of the patient in another post-marketing study with etanercept is not permitted.
研究组 & 干预措施
Observation Group
干预措施: Etanercept (Drug)
结局指标
主要结局
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12
时间窗: Week 12
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12
时间窗: Week 12
Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24
时间窗: Week 24
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks
时间窗: Week 12 up to Week 52
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks
时间窗: Week 24 up to Week 52
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1
时间窗: Week 12
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12
时间窗: Week 12
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24
时间窗: Week 24
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24
时间窗: Week 24
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24
时间窗: Week 24
DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.
次要结局
- Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS)(Baseline up to Weeks 12, 24, 36, 52)
- Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set(Baseline up to Weeks 12, 24, 36, 52)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set(Baseline up to Weeks 12, 24, 36, 52)
- Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set(Baseline up to Weeks 12, 24, 36, 52)
- Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events(Baseline up to Week 52)
- Number of Participants Who Switched to Other Therapy After Treatment Discontinuation(Baseline up to Week 52)
- Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52(Weeks 12, 24, 36, 52)
- Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52(Baseline, Weeks 12, 24, 36, 52)
- Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO)(Baseline up to Week 24)
- Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO)(Weeks 12, 24, 36, 52)
- Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO)(Weeks 12, 24, 36, 52)
- Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)
- Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52(Weeks 12, 24, 36, 52)