A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
- Registration Number
- NCT00293826
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 813
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 AMG 108 196 subjects 4 Placebo 196 subjects 1 AMG 108 196 subjects 2 AMG 108 196 subjects
- Primary Outcome Measures
Name Time Method ACR20 response 24 Weeks
- Secondary Outcome Measures
Name Time Method Change in subject reported outcomes 24 Weeks ACRn, AUC ACRn, ACR50, ACR70, and DAS28 24 Weeks PK parameters 24 Weeks Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status 24 Weeks