INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: INCB028050; INCB028050; INCB028050; Placebo
Intervention description: 4 mg capsules QD; 7 mg capsules QD; 10 mg capsule QD; Placebo matching INCB028050 QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis

Summary:

      This was a randomized, double blind, placebo controlled, dose ranging, parallel group study.
      Participants who had active rheumatoid arthritis (RA) who had inadequate response to any
      disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled.
      Screening evaluations were performed within approximately 28 days of randomization. The
      duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible
      participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050
      (Baricitinib) or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have rheumatoid arthritis which has been inadequately controlled with at least
             one DMARD

          -  For subjects receiving antimalarials, they must be treated with antimalarials for at
             least 6 months and receiving a stable daily dose

          -  For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ)
             for at least 6 months and receiving a stable daily dose of no more than 3 grams per
             day

          -  For subjects on methotrexate, they must be treated with methotrexate for at least 6
             months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg

          -  For subjects on leflunomide, they must be treated with leflunomide for at least 6
             months, and receiving a stable dose of leflunomide between 10 to 20 mg

          -  For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of
             prednisone daily

          -  Active rheumatoid arthritis at the time of screening defined by the following: 6 or
             more joints tender or painful on motion and 4 or more swollen joints and at least one
             of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28
             mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter

          -  Have evidence of lack of risk for tuberculosis

        Exclusion Criteria:

          -  Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection
             requiring systemic therapy

          -  History of infected joint prosthesis

          -  Subjects who have a current or recent history of severe, progressive, uncontrolled
             renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or
             cerebral disease

          -  Subjects who have received treatment with the following drugs or drug classes within
             the specified timeframe: prior treatment with rituximab within 12 months, prior
             treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic
             therapies not specified and allowed according to protocol, treatment with any
             investigational medication within 12 weeks or 5 half-lives (whichever is longer), and
             treatment with a biologic agent within 12 weeks prior to the first dose of study
             medication

          -  Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring
             transfusion other than at the time of trauma or surgery, and subjects that meet
             protocol specified laboratory measures