INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
127 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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