Status:
COMPLETED
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
Eligibility Criteria
Inclusion
- Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
- Must be taking MTX consecutively for \>/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening
Exclusion
- Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
- Presence of serious infection
- Class IV rheumatoid arthritis
- Prior or current history of tuberculosis infection or exposure
- Any other DMARDs other than methotrexate within 6 weeks of screening
- Pregnant or nursing
- Receipt of live vaccines within 3 months
- Felty's syndrome
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT00293826
Start Date
March 1 2006
End Date
February 1 2008
Last Update
March 5 2010
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