An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Infliximab; Methotrexate
Intervention description: Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.; MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.
Intervention MeSH terms: Infliximab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Arthritis, Rheumatoid; Infliximab; Methotrexate

Summary:

      The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate
      (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune
      disease that causes pain, swelling, stiffness and loss of function in joints) in participants
      with moderate disease versus participants with severe disease and to compare the efficacy and
      safety of the MTX subgroups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the
             American College of Rheumatology Criteria 1987

          -  Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for
             at least 4 weeks

          -  Participants using oral corticosteroids, must have been on a stable dose of prednisone
             less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before
             screening or if currently not using corticosteroids, the participant must not have
             received corticosteroids for at least 4 weeks before screening

          -  Participants with moderate to severe RA (Disease Activity Score [DAS28] greater than
             3.2)

          -  Male participants shall adopt contraceptive measures during the trial and within 6
             months after the completion of trial (such as spermicidal barrier), or their female
             sexual partners shall agree to adopt effective contraceptive measures during the trial
             or within 6 months after the completion of trial (such as oral contraceptives,
             contraceptives for injection, intrauterine device [IUD], or sterilization by surgery);
             female participants of childbearing potential with negative urine pregnancy test upon
             enrollment in addition to adopting the said contraceptive measures

        Exclusion Criteria:

          -  Participant who has a known allergy to human immunoglobulin proteins or other
             components of infliximab

          -  Participant who has a history of receiving infliximab or any other biological
             preparations

          -  Participant who is in stage IV RA evaluated by X-ray

          -  Participants suffering from tuberculosis

          -  Female participant or male participant's wife who plans to become pregnant during this
             study and within 6 months after completion of this study