drugset / Trial / NCT00422227
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
Timeline
- Start
- 2007-06
- Primary completion
- 2009-03
- Completion
- 2009-03
Publications
- Fleischmann R, Koenig AS, Szumski A, Nab HW, Marshall L, Bananis E. Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford). 2014 Nov;53(11):1984-93. doi: 10.1093/rheumatology/keu235. Epub 2014 Jun 6.
- Bae SC, Gun SC, Mok CC, Khandker R, Nab HW, Koenig AS, Vlahos B, Pedersen R, Singh A. Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis. BMC Musculoskelet Disord. 2013 Jan 8;14:13. doi: 10.1186/1471-2474-14-13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 25 mg | Subcutaneous |
| Comparator | Hydroxychloroquine | Small molecule | 6.5 mg/kg | Oral |
| Comparator | Hydroxychloroquine | Small molecule | 200 mg | Oral |
| Comparator | Hydroxychloroquine | Small molecule | 400 mg | Oral |
| Comparator | Leflunomide | Small molecule | 20 mg | Oral |
| Comparator | Sulfasalazine | Small molecule | 3 g | Oral |
| Comparator | Methotrexate | Small molecule | 7.5 mg | — |
| Comparator | Methotrexate | Small molecule | 25 mg | — |