At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Meet ACR/EULAR 2010 RA classification criteria; not diagnosed before age 16
- ✓Functional class I, II, or III (ACR 1992 classification)
- ✓Active disease: swollen joint count ≥4 (66-joint count) AND tender joint count ≥4 (68-joint count) at screening and Day 1
- ✕Pregnant, lactating, or planning pregnancy/breastfeeding
- ✕History of other inflammatory rheumatologic or autoimmune disorders (except secondary Sjögren's syndrome in RA)
- ✕History of respiratory disease compromising safety (interstitial lung disease, pulmonary fibrosis, COPD, moderate-severe asthma, bronchiectasis, pulmonary alveolar proteinosis)
- ✕Clinically significant unexplained persistent cough or clinically significant unstable dyspnea
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDs
In Brief
A Phase 2 clinical trial evaluating GSK3196165, Placebo, and 2 other interventions for Arthritis, Rheumatoid. Completed, enrolled 39 participants across 16 sites in 3 countries.
Detailed 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).
Study Details
Timeline
Interventions
GSK3196165 is supplied as liquid and will be administered as SC injection.
0.9% weight by volume (w/v) sodium chloride solution administered as SC injection.
Capsule, tablet or liquid administered orally or as SC injection.
Capsule, tablet or liquid and will be administered orally.