RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY TO SUBJECT WITH RHEUMATOID ARTHRITIS.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 195
- 试验地点
- 52
- 主要终点
- Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
- •Active RA at the time of screening and baseline consisting of >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
- •Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.
排除标准
- •Subjects with other rheumatic diseases
- •Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
- •Any prior use of B cell-depleting therapy
研究组 & 干预措施
Arm 1
Part 1: Placebo
干预措施: Placebo (Other)
Arm 2
Part 1: 100 mg ILV-094 SC Q4W
干预措施: ILV-094 (Drug)
Arm 3
Part 1: 100 mg ILV-094 SC Q2W
干预措施: ILV-094 (Drug)
Arm 4
干预措施: Placebo (Other)
Arm 5
Part 2: 200 mg ILV-094 SC Q2W
干预措施: ILV-094 (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
时间窗: Week 12
ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
次要结局
- Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10(Week 2, 4, 6, 8, 10)
- Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12(Week 2, 4, 6, 8, 10, 12)
- Tender Joints Counts (TJC)(Baseline, Week 2, 4, 6, 8, 10, 12)
- Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)(Baseline, Week 2, 4, 6, 8, 10, 12)
- Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR)(Baseline, Week 2, 4, 6, 8, 10, 12)
- Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12(Week 2, 4, 6, 8, 10, 12)
- Swollen Joints Count (SJC)(Baseline, Week 2, 4, 6, 8, 10, 12)
- Physician Global Assessment of Disease Activity(Baseline, Week 2, 4, 6, 8, 10, 12)
- Participant Global Assessment of Disease Activity(Baseline, Week 2, 4, 6, 8, 10, 12)
- Pain Visual Analog Scale (VAS)(Baseline, Week 2, 4, 6, 8, 10, 12)
- General Health Visual Analog Scale (VAS)(Baseline, Week 2, 4, 6, 8, 10, 12)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline, Week 4, 2, 6, 8, 10, 12)
- 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 4, 8, 12)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Baseline, Week 4, 8, 12)
- Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28(Week 2, 4, 6, 8, 10, 12)