Trials / Completed
CompletedNCT00547521
Phase IIIB Subcutaneous Abatacept Monotherapy Study
A Phase IIIb, Multi-center, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background Methotrexate
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | abatacept | solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open |
| DRUG | Methotrexate (MTX) | Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2008-12-01
- Completion
- 2014-02-01
- First posted
- 2007-10-22
- Last updated
- 2015-03-23
- Results posted
- 2011-01-24
Locations
22 sites across 4 countries: United States, Australia, Mexico, South Africa
Source: ClinicalTrials.gov record NCT00547521. Inclusion in this directory is not an endorsement.