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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00550043 |
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Date of registration:
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24/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
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Scientific title:
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A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00550043 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Poland
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United States
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Contacts
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Name:
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Monica Luchi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Incyte Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Established diagnosis of rheumatoid arthritis
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:
1. 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;
2. Treatment with any investigational medication within 12 weeks prior to the first dose
of study medication.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: INCB018424
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Drug: Placebo
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Primary Outcome(s)
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The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
[Time Frame: Day 28]
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Secondary Outcome(s)
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Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
[Time Frame: Day 28]
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Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
[Time Frame: Day 28]
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Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
[Time Frame: Day 28]
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Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
[Time Frame: Baseline, Day 28]
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Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
[Time Frame: Baseline, Day 28]
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Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
[Time Frame: Day 28]
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The Percentage of Subjects Achieving ACR 50 Improvement
[Time Frame: Day 28]
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The Percentage of Subjects Achieving ACR 70 Improvement
[Time Frame: Day 28]
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Secondary ID(s)
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INCB 18424-231
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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