Trials / Completed
CompletedNCT02799472
Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis
A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDs
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3196165 | GSK3196165 is supplied as liquid and will be administered as SC injection. |
| DRUG | Placebo | 0.9% weight by volume (w/v) sodium chloride solution administered as SC injection. |
| DRUG | MTX | Capsule, tablet or liquid administered orally or as SC injection. |
| DRUG | Folic (or folinic) acid | Capsule, tablet or liquid and will be administered orally. |
Timeline
- Start date
- 2016-06-15
- Primary completion
- 2017-10-30
- Completion
- 2017-10-30
- First posted
- 2016-06-14
- Last updated
- 2021-01-11
- Results posted
- 2018-11-16
Locations
16 sites across 3 countries: United States, Germany, Poland
Source: ClinicalTrials.gov record NCT02799472. Inclusion in this directory is not an endorsement.