drugset / Trial / NCT02379091
Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).
Timeline
- Start
- 2014-12-17
- Primary completion
- 2016-05-11
- Completion
- 2016-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Namilumab | Monoclonal antibody | 20 mg | Subcutaneous |
| Subject | Namilumab | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Namilumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Background | Folic/folinic acid | Unknown | — | Oral |
| Background | Methotrexate | Small molecule | — | Oral |