A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
NCT ID: NCT00550043
Last Updated: 2015-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2007-10-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1: Treatment Group A
INCB018424 15 mg twice daily (BID) or matching placebo
INCB018424
Cohort 2: Treatment Group B
INCB018424 5 mg BID or matching placebo
INCB018424
Cohort 2: Treatment Group C
INCB018424 25 mg BID or matching placebo
INCB018424
Cohort 2: Treatment Group D
INCB018424 50 mg once daily (QD) or matching placebo
INCB018424
Placebo
Matching placebo, oral
Placebo
Interventions
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INCB018424
Placebo
Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
* 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;
2. Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
18 Years
70 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Monica Luchi, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Huntsville, Alabama, United States
Upland, California, United States
Gainesville, Florida, United States
Palm Harbor, Florida, United States
Kalispell, Montana, United States
Hickory, North Carolina, United States
Mayfield Village,, Ohio, United States
Middleburg Heights, Ohio, United States
Perrysburg, Ohio, United States
Pittsburgh, Pennsylvania, United States
Hixson, Tennessee, United States
Memphis, Tennessee, United States
Elblag, , Poland
Gmina Końskie, , Poland
Warsaw, , Poland
Countries
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Other Identifiers
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INCB 18424-231
Identifier Type: -
Identifier Source: org_study_id
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