drugset / Trial / NCT00409838
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate
Timeline
- Start
- 2007-04
- Primary completion
- 2008-07
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 10 mg/kg | Intravenous |
| Subject | Abatacept | Other / unclassified | 500 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 750 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 1 g | Intravenous |
| Background | Methotrexate | Small molecule | 15 mg | Oral |