A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Overview
- Phase
- Phase 4
- Intervention
- Abatacept
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 405
- Locations
- 2
- Primary Endpoint
- American College of Rheumatology (ACR) 20% response rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.
Investigators
Eligibility Criteria
Inclusion Criteria
- •MTX inadequate responder
- •Biologic Naïve
- •Functional class I, II or III
- •≥6 swollen and ≥6 tender joints
- •C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
- •Anti-cyclic citrullinated peptide (CCP) antibody positive
- •Have erosion
Exclusion Criteria
- •Any other rheumatic disease
- •Active angiitis on main organs excluding rheumatoid nodule
Arms & Interventions
Group 1: Abatacept + Methotrexate (MTX)
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Intervention: Abatacept
Group 1: Abatacept + Methotrexate (MTX)
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Intervention: Methotrexate
Group 2: Placebo matching with Abatacept + Methotrexate
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Intervention: Placebo matching with Abatacept
Group 2: Placebo matching with Abatacept + Methotrexate
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Intervention: Methotrexate
Outcomes
Primary Outcomes
American College of Rheumatology (ACR) 20% response rate
Time Frame: 4 months (week 16)
Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
Time Frame: Baseline (Day 1), 6 months (Week 24)
Secondary Outcomes
- Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)(Baseline (Day 1), 4 months (Week 16))
- Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities(12 months (Week52))
- ACR 70 response rates(4 months (Week16))
- Non-progressors rate for the structural damage(Baseline (Day 1), 6 months (Week 24))
- ACR 50 response rates(4 months (Week16))