Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.
Verified date | March 2010 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 813 |
Est. completion date | February 2008 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR20 response | 24 Weeks | No | |
Secondary | Change in subject reported outcomes | 24 Weeks | No | |
Secondary | ACRn, AUC ACRn, ACR50, ACR70, and DAS28 | 24 Weeks | No | |
Secondary | PK parameters | 24 Weeks | No | |
Secondary | Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status | 24 Weeks | Yes |
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