Status:
COMPLETED
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
Lead Sponsor:
Procter and Gamble
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients w...
Detailed Description
The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study. The study will...
Eligibility Criteria
Inclusion
- Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
- Disease duration of at least 6 months
- Must be treated with Methotrexate for at least 24 weeks
- At least 6 swollen joints and 6 tender joints
- Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
- Women of childbearing age and all males must use acceptable method of birth control
Exclusion
- Tuberculosis
- Malignancies
- Abnormal electrocardiograms as described in the protocol
- Current infection or recurrent infections or immunodeficiency
- Liver diseases and abnormalities in liver function tests as described in the protocol
- Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
- History of demyelization diseases
- Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00369928
Start Date
August 1 2006
End Date
January 1 2008
Last Update
September 8 2011
Active Locations (53)
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1
Research Facility
Hot Springs, Arkansas, United States, 71913
2
Research Facility
Beverly Hills, California, United States, 90211
3
Research Facility
Mission Viejo, California, United States, 92691
4
Research Facility
Chiefland, Florida, United States, 32626