A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: INCB018424 (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Incyte Corporation Official(s) and/or principal investigator(s): Monica Luchi, MD, Study Director, Affiliation: Incyte Corporation
Summary
The purpose of this study is to understand the safety and tolerability of INCB018424 in
patients with rheumatoid arthritis
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
Secondary outcome: The Percentage of Subjects Achieving ACR 50 ImprovementThe Percentage of Subjects Achieving ACR 70 Improvement Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score Percentage of Subjects Who Achieved DAS 28 ESR Low Disease Percentage of Subjects Who Achieved DAS 28 CRP Low Disease Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Elblag, Poland
Konskie, Poland
Warszawa, Poland
Huntsville, Alabama 35801, United States
Upland, California 91786, United States
Gainesville, Florida 32607, United States
Palm Harbor, Florida 34684, United States
Kalispell, Montana 59901, United States
Hickory, North Carolina 28601, United States
Mayfield Village,, Ohio 44143, United States
Middleburg Heights, Ohio 44130, United States
Perrysburg, Ohio 43551, United States
Pittsburgh, Pennsylvania 15261, United States
Hixson, Tennessee 37343, United States
Memphis, Tennessee 38119, United States
Additional Information
Starting date: October 2007
Last updated: March 9, 2015
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