Status:
COMPLETED
A Study of ARRY-371797 in Patients With Rheumatoid Arthritis
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study, involving a 29-day treatment period, designed to evaluate the pharmacokinetics and the effectiveness of investigational study drug ARRY-371797 in treating rheumatoid arthritis...
Eligibility Criteria
Inclusion
- Key
- Diagnosed with rheumatoid arthritis (RA) at least 3 months prior to study start based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- On a stable weekly dose of both methotrexate (MTX) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
- Meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III.
- Completed an appropriate washout period if treated with specified therapies.
- Patients may continue on specified stable background therapy for RA (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with Sponsor approval).
- Additional criteria exist.
- Key
Exclusion
- Diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- Has received any of the following prior treatments:
- Within 4 weeks of first dose of study drug: anakinra (Kineret®), etanercept (Enbrel®);
- Within 8 weeks of first dose of study drug: infliximab (Remicade®), adalimumab (Humira®), leflunomide (Arava®);
- At any time: rituximab (Rituxan®), alemtuzumab (CamPath®), any experimental B cell targeting agents.
- Treatment with potent CYP3A inhibitors or inducers, disease-modifying antirheumatic drugs (DMARDs) and/or biologic response modifiers (BRMs) during the study.
- Additional criteria exist.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00729209
Start Date
July 1 2008
End Date
April 1 2009
Last Update
September 21 2020
Active Locations (7)
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1
Clinic for Rheumatic Diseases
Tuscaloosa, Alabama, United States, 35406
2
Sun Valley Arthritis Center, Ltd
Peoria, Arizona, United States, 85381
3
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
4
NUCATS Institute, Northwestern University
Chicago, Illinois, United States, 60611