Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis
Summary
This study is designed to explore the activity of granulocyte-macrophage colony stimulating factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential impact of inhibition of this axis by GSK3196165, and to evaluate whether there are any differences in the GM-CSF axis between subjects with early RA compared with those with more established disease. This study also aims to establish the potential impact of GSK3196165 on inflammatory structural joint damage in the hand/wrist using magnetic resonance imaging (MRI). This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled parallel group study. Approximately 40 subjects with active RA despite treatment with disease-modifying antirheumatic drugs (DMARDs) (including conventional or biologic) will be randomized into the study, following a screening period of up to 6 weeks. The total treatment period is up to 10 weeks, with a 12-week follow-up period after the last dose (Week 22).
Timeline
- Start
- 2016-06-15
- Primary completion
- 2017-10-30
- Completion
- 2017-10-30
Outcome
Mixed primary results
registry analysis (other test); Placebo vs GSK3196165 180 mg; p <0.001; Ratio 14.201 (95% CI 6.251 to 32.262); Repeated measures analysis NCT02799472 ↗
registry analysis (other test); Placebo vs GSK3196165 180 mg; p = 0.558; Ratio 0.953 (95% CI 0.809 to 1.123); Repeated measures analysis NCT02799472 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Otilimab | Monoclonal antibody | — | Subcutaneous |
| Background | Folic (or folinic) acid | Unknown | 5 mg | Oral |
| Background | MTX | Unknown | 15 mg | Oral |
| Background | MTX | Unknown | 25 mg | Oral |