A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo + methotrexate (MTX) (Group 1); Ustekinumab + MTX (Group 2); Ustekinumab + MTX (Group 3); CNTO 1959 + MTX (Group 4); CNTO 1959 + MTX (Group 5)
Intervention description: Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose); Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose); Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose); CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose); CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)
Intervention MeSH terms: Methotrexate; Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Active rheumatoid arthritis; Ustekinumab; STELARA; CNTO 1959

Summary:

      The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in
      reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA)
      despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and
      CNTO 1959 in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had RA for at least 6 months prior to screening

          -  Have a diagnosis of RA according to the revised 1987 criteria of the American
             Rheumatism Association - Be positive for either anti-cyclic citrullinated peptide
             antibody or rheumatoid factor in serum at screening

          -  Have been treated with and tolerated MTX for at least 6 months prior to screening, and
             have a MTX dose of >= 10 mg and <= 25 mg per week and stable for at least 12 weeks
             prior to first administration of study agent

          -  Have active RA, defined as persistent disease activity with both of the following
             criteria: at least 6 swollen and 6 tender joints at the time of screening and
             baseline; serum C-reactive protein (CRP) >= 0.80 mg/dL at screening. The investigator
             may consider the patient eligible if the CRP value is at least 0.80 mg/dL in a single
             repeat testing during the screening period

          -  If using oral corticosteroids, must be on a stable dose of <= 10 mg/day of prednisone
             or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to the
             first administration of study agent. If not using corticosteroids at Week 0, the
             patient must not have received oral corticosteroids for at least 2 weeks prior to the
             first administration of study agent

          -  If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics regularly
             for RA, the patient must have been on a stable dose for at least 2 weeks prior to the
             first administration of study agent. If not using NSAIDs or other analgesics for RA at
             Week 0, the patient must have not received NSAIDs or other analgesics for RA for at
             least 2 weeks prior to the first administration of study agent

        Exclusion Criteria:

          -  Has other inflammatory diseases, including but not limited to psoriatic arthritis,
             ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease, that might
             confound the evaluation of the benefit of study agent therapy

          -  Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary,
             gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic
             disturbances that are severe, progressive, or uncontrolled

          -  Has any known malignancy or history of malignancy (with the exception of basal cell
             carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ
             that has been treated with no evidence of recurrence, or squamous cell carcinoma of
             the skin that has been treated with no evidence of recurrence within 5 years prior to
             the first administration of study agent)

          -  Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive
             of possible lymphoproliferative disease such as lymphadenopathy of unusual size or
             location, or clinically significant splenomegaly

          -  Has known allergies, hypersensitivity, or intolerance to ustekinumab or CNTO 1959 or
             its inactive ingredients

          -  Has ever received any approved or investigational biologic agent