drugset / Trial / NCT00445770
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
Timeline
- Start
- 2006-07
- Primary completion
- 2010-07
- Completion
- 2010-07
Publications
- Takeuchi T, Miyasaka N, Pedersen RD, Sugiyama N, Hirose T. Radiographic and clinical effects of 10 mg and 25 mg twice-weekly etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis. Mod Rheumatol. 2021 Mar;31(2):319-325. doi: 10.1080/14397595.2020.1805142. Epub 2020 Sep 7.
- Takeuchi T, Miyasaka N, Pedersen R, Sugiyama N, Hirose T. Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naive patients with active rheumatoid arthritis. Mod Rheumatol. 2020 Mar;30(2):259-268. doi: 10.1080/14397595.2019.1589918. Epub 2019 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etanercept | Protein / enzyme biologic | 10 mg | Subcutaneous |
| Subject | Etanercept | Protein / enzyme biologic | 25 mg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 8 mg | Oral |