Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments abatacept, methotrexate, abatacept placebo, methotrexate placebo
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date August 2010
End date September 2013
Trial size 511 participants
Trial identifier NCT01142726, 2010-018674-20, IM101-226

Summary

The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
abatacept Orencia
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
methotrexate Rheumatrex
Tablets, oral, 2.5 mg, once weekly, 12 months
(Active Comparator)
Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
methotrexate Rheumatrex
Tablets, oral, 2.5 mg, once weekly, 12 months
abatacept placebo
Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months
(Active Comparator)
Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
abatacept Orencia
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
methotrexate placebo
Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months

Primary Outcomes

Measure
Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
time frame: Randomization to Months 12 and 18

Secondary Outcomes

Measure
Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
time frame: Randomization to Months 12 and 18
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time
time frame: Randomization to Month 18
Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18
time frame: Baseline to Month 18
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18
time frame: Randomization to Month 18
Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time
time frame: Randomization to Month 18
Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time
time frame: Randomization to Month 18
Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response Over Time
time frame: Randomization to Month 18
Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical and Mental Component Summary Scores of Short Form-36 (SF-36)
time frame: Randomization to Months 6, 12, and 18
Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)
time frame: Randomization to Month 18
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period
time frame: Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period
Adverse Events (AEs) of Interest During the Treatment Period
time frame: Day 1 to 56 days following last dosing day (Day 365)
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality
time frame: Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening - Onset of persistent symptoms ≤ 2 years prior to screening - Positive test result for anticyclic citrullinated peptides 2 - Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit - Biologic naive, including no treatment with an investigational biologic prior to screening - Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening - Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization - If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks - Able to undergo magnetic resonance imaging Key Exclusion Criteria: - Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus) - Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization - Scheduled for or anticipating joint replacement surgery - Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator - History of malignancy in the last 5 years - Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection - At risk for tuberculosis - Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment

Additional Information

Official title A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.