A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept
Intervention description: Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the safety of chronic use of abatacept in
      Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071,
      IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX
      intolerance.
    

Eligibility criteria:

        Inclusion Criteria

          -  The participants who completed the 169 days, full study period of Phase II (IM101-071)
             and were not administered other biologics between completion of IM101-071 and
             registration of this long-term study.

          -  The participants of the Phase I study (IM101-034), who received abatacept, except
             participants who were withdrawn from the study due to safety problems related to
             abatacept.

          -  New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX
             cannot be administered for safety reasons and who present an inadequate response to
             disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new
             subjects with MTX intolerance: RA patients who present an inadequate response to
             DMARDs).

        Exclusion Criteria

          -  Women of childbearing potential (WOCBP) who were unwilling or unable to use an
             acceptable method of contraception.

          -  Participants who have received non approved or investigational biologics (other than
             abatacept from previous or ongoing studies in Japan) at registration.

          -  Participants who have received treatment with any investigational drug within 56 days
             before registration or five half-lives (whichever is the longest).

          -  Participants currently receiving treatment with leflunomide, mycophenolate mofetil,
             calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine,
             Cyclophosphamide, or immunoadsorption columns.

          -  The participants who completed Phase II (IM101-071) are not applicable in the
             following instances at time of registration: with active vasculitis, symptoms of
             severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal,
             pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of
             cancer within the last 5 years, evidence of active or latent bacterial , viral
             infections, any serious or chronic, at risk of tuberculosis (TB), with any
             opportunistic infections, laboratory values of hemoglobin < 8.5 g/dL, white blood
             cells (WBC) < 3,000/mm^3, Platelets < 100,000/mm^3, Serum creatinine > 2 times upper
             limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase > 2
             times ULN.