A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP 690,550; CP-690,550; Placebo; Placebo; Biologic TNFi
Intervention description: tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months; tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months; placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months; tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months; placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
Intervention MeSH terms: Adalimumab; Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 717.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral DMARD; JAK inhibitor; clinical trial

Summary:

      This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background
      methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence
      of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background
      methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended
      to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function
      that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also
      included.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a diagnosis of RA based upon the American College of Rheumatology
             (ACR) 1987 Revised Criteria.

          -  The patient must have had an inadequate response to methotrexate and have active
             disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints
             swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren
             method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.

          -  No evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis.

          -  The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate
             and washed out of all other DMARDs.

        Exclusion Criteria:

          -  Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2.
             White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4.
             Platelet count <100,000/L

          -  History of any other autoimmune rheumatic disease other than Sjogren's syndrome

          -  No malignancy or history of malignancy.

          -  History of infection requiring hospitalization, parenteral antimicrobial therapy, or
             as otherwise judged clinically significant by the investigator, within the 6 months
             prior to the first dose of study drug

          -  Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism
             related adverse event.

          -  Patients who have previously received adalimumab therapy for any reason.

          -  Patients who are contraindicated for treatment with adalimumab in accordance with the
             approved local label.

          -  Patients meeting the New York Heart Association Class III and Class IV Congestive
             Heart failure