A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Infliximab; Placebo
Intervention description: 3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion; 250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion
Intervention MeSH terms: Infliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study to compare the effect of infliximab versus placebo on synovial inflammation
      as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is
      that over 14 weeks of therapy, the change from baseline in the volume transfer rate in
      enhancing synovium is larger due to treatment with infliximab than with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a clinical diagnosis of rheumatoid arthritis for at least 6 months

          -  Must have at least 6 tender joints AND 6 swollen joints

          -  Has a C-reactive protein ≥ 1.0 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr

          -  Baseline MRI must show evidence of synovitis in the wrist

          -  Must have screening laboratory tests within acceptable levels

          -  Women of childbearing potential and all men must agree to use a medically accepted
             method of contraception prior to entering the study and continue throughout study up
             to 6 weeks after study completion

          -  Must meet tuberculosis (TB) screening criteria

          -  Have received methotrexate therapy for ≥ 3 months; dose must be stable for at least 8
             weeks

          -  If taking the a disease modifying anti-rheumatic drug (DMARD) in combination with
             methotrexate must be on a stable dose

          -  Must have a clinically acceptable 12 lead electrocardiogram (ECG)

          -  If taking oral corticosteroids must be on a stable dose equivalent to ≤10 mg of
             prednisone (or prednisolone) per day for ≥2 weeks

          -  If taking daily non-steroidal anti-inflammatory drug (NSAID) must be on a stable dose
             for ≥2 weeks; if taking NSAID on an as-needed basis must agree to discontinue use for
             at least 3 days and use only acetaminophen for breakthrough pain for 3 days before
             each MRI and clinic visit

          -  If received biological therapies, the last dose of these drugs was to be received ≥ 3
             months prior to the baseline visit AND the reason for discontinuations was not for
             safety considerations OR lack of efficacy

        Exclusion Criteria:

          -  Are pregnant, intend to become pregnant, or are breastfeeding

          -  Has inflammatory arthritis other than RA

          -  Has uncontrolled hypertension

          -  Has moderate or severe congestive heart failure

          -  Has a history of or current signs and/or symptoms of severe, progressive, or
             uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
             cardiac, neurological, cerebral, or psychiatric disease

          -  Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis or
             optic neuritis

          -  Is currently participating in another clinical study or have participated in a
             clinical study (e.g., laboratory or clinical evaluation) within 4 weeks

          -  Has history of any tumor with the exception of adequately treated basal cell carcinoma
             or carcinoma in situ of the cervix

          -  Has a history of any latent or active granulomatous infection including
             histoplasmosis, or coccidiomycosis

          -  Had a non-tuberculous mycobacterial infection or opportunistic infection (e.g.
             cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months

          -  Has a history of an infected joint prosthesis which has not been removed or replaced

          -  Has a known hypersensitivity to human immunoglobulin proteins or other components of
             infliximab

          -  Has received rituximab or natalizumab

          -  Has known claustrophobia or other contraindication to MRI

          -  Does not meet washout period guidelines for previous
             treatments/injections/vaccinations