Status:
COMPLETED
A Study of ARRY-438162 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:
PHASE2
Brief Summary
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable d...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
- Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
- Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
- No prior use of biological agents for the treatment of rheumatoid arthritis.
- Additional criteria exist.
- Key
Exclusion
- Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
- Additional criteria exist.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00650767
Start Date
March 1 2008
End Date
July 1 2009
Last Update
December 1 2020
Active Locations (35)
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1
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
2
Asistencia Integral en Reumatologia
Buenos Aires, Argentina
3
CEMIC
Buenos Aires, Argentina
4
Hospital Britanico
Buenos Aires, Argentina