RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY TO SUBJECT WITH RHEUMATOID ARTHRITIS.
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Pfizer
- Enrollment
- 195
- Locations
- 52
- Primary Endpoint
- Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Arm 1
Part 1: Placebo
Intervention: Placebo
Arm 2
Part 1: 100 mg ILV-094 SC Q4W
Intervention: ILV-094
Arm 3
Part 1: 100 mg ILV-094 SC Q2W
Intervention: ILV-094
Arm 4
Intervention: Placebo
Arm 5
Part 2: 200 mg ILV-094 SC Q2W
Intervention: ILV-094
Outcomes
Primary Outcomes
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
Time Frame: 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).
Secondary Outcomes
- 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)