A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Key facts

Study ID

NCT00550043

Run by

Incyte Corporation

People needed

50

Starts

2007-10-01

Expected to finish

2008-09-01

Last updated by the study team

2015-03-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established diagnosis of rheumatoid arthritis
• Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

You may not qualify if…

• Patients who have taken the following drugs within the timeframe below:
• Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
• Rituximab - Within 12 months prior to the first dose of study medication;
• Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
• Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Upland, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Kalispell, Montana, United States
• Study site — Hickory, North Carolina, United States
• Study site — Mayfield Village,, Ohio, United States
• Study site — Middleburg Heights, Ohio, United States
• Study site — Perrysburg, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Hixson, Tennessee, United States
• Study site — Memphis, Tennessee, United States
• Study site — Elblag, Poland
• Study site — Gmina Końskie, Poland
• Study site — Warsaw, Poland

Full record on ClinicalTrials.gov

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