Trials / Terminated
TerminatedNCT02965599
Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis
A Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid Arthritis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
GSK3117391 has the potential to complement existing therapies in the treatment of chronic inflammatory disorders such as rheumatoid arthritis (RA). This study will evaluate the efficacy, safety and tolerability of oral GSK3117391 (Dose A) administered to subjects with severe RA despite treatment with disease-modifying anti-rheumatic drugs (DMARDs). This is a randomised, double-blind (sponsor open), multicentre, placebo-controlled, parallel group study. The total maximum study duration is approximately 10 weeks. Following a screening period of up to 28 days, subjects will be randomized (1:1) to placebo or GSK3117391 (Dose A) administered orally for a period of 28 days. Subjects will be followed up for 7 to 14 days post final dose. Approximately 40 subjects with severe RA will be randomised into the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3117391 | GSK3117391 (Dose A) is a white, opaque, gelatin capsule. |
| DRUG | Placebo | Placebo is a white, opaque, gelatin capsule. |
Timeline
- Start date
- 2016-12-27
- Primary completion
- 2017-11-14
- Completion
- 2017-11-14
- First posted
- 2016-11-17
- Last updated
- 2020-10-30
- Results posted
- 2019-03-26
Locations
5 sites across 2 countries: Poland, Romania
Source: ClinicalTrials.gov record NCT02965599. Inclusion in this directory is not an endorsement.