INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00902486

Run by

Incyte Corporation

People needed

127

Starts

2009-05-01

Expected to finish

2010-07-01

Last updated by the study team

2018-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Palm Desert, California, United States
• Study site — Santa Maria, California, United States
• Study site — Santa Monica, California, United States
• Study site — Westlake Village, California, United States
• Study site — Whittier, California, United States
• Study site — Denver, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Lake Mary, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Springfield, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Frederick, Maryland, United States
• Study site — Wheaton, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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