Clinical Trials Logo
  1. Home
  2. Arthritis, Rheumatoid
  3. NCT04134728

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors — contRAst 3  

Arthritis, Rheumatoid Clinical Trial

Official title:
A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors

Clinical Trial Summary

This study (contRAst 3 [202018: NCT04134728]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD[s]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD[s]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X [209564: NCT04333147]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04134728
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date October 31, 2019
Completion date February 1, 2022
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01682512 - Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis Phase 3
Completed NCT00539760 - A Phase I Rheumatoid Arthritis Study in Healthy Volunteers Phase 1
Active, not recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Completed NCT01208181 - A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107) Phase 3
Completed NCT03254810 - Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects Phase 1
Completed NCT01711814 - A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study Phase 2
Completed NCT03315494 - Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers Phase 1
Withdrawn NCT03241446 - Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) Phase 1
Completed NCT02748785 - MTX Discontinuation and Vaccine Response Phase 4
Completed NCT02553018 - Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe Phase 3
Active, not recruiting NCT02260778 - Treat-to-target in RA: Collaboration To Improve adOption and adhereNce N/A
Completed NCT02569736 - Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
Completed NCT01750931 - This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. Phase 2
Withdrawn NCT01204138 - Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA Phase 2
Not yet recruiting NCT01154647 - Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes N/A
Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00660647 - Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) Phase 3
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2