Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept placebo; Drug: Methotrexate; Drug: Methotrexate placebo; Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01142726

IM101-226

2010-018674-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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511 participants in 3 patient groups

Abatacept, 125 mg, plus methotrexate, 2.5 mg

Active Comparator group

Description:

Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period

Treatment:

Drug: Abatacept

Drug: Methotrexate

Methotrexate, 2.5 mg, plus abatacept placebo

Active Comparator group

Description:

Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period

Treatment:

Drug: Abatacept placebo

Drug: Methotrexate

Abatacept, 125 mg, plus methotrexate placebo

Active Comparator group

Description:

Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period

Treatment:

Drug: Abatacept

Drug: Methotrexate placebo