drugset / Trial / NCT00966875
A Study in Patients With Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA): * The safety of LY2439821 and any side effects that might be associated with it. * Whether LY2439821 can help participants with active RA. * How much LY2439821 should be given to participants.
Timeline
- Start
- 2009-08
- Primary completion
- 2011-03
- Completion
- 2012-06
Publications
- Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H. Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831. Epub 2015 Dec 15.
- Genovese MC, Greenwald M, Cho CS, Berman A, Jin L, Cameron GS, Benichou O, Xie L, Braun D, Berclaz PY, Banerjee S. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014 Jul;66(7):1693-704. doi: 10.1002/art.38617.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixekizumab | Monoclonal antibody | 3 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 10 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 160 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 180 mg | Subcutaneous |