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Monoclonal Antibodies

GSK3196165 90mg + csDMARD (Global Cohort) for Rheumatoid Arthritis (contRAst 2 Trial)

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights

contRAst 2 Trial Summary

This study is evaluating whether a drug may help treat rheumatoid arthritis.

Eligible Conditions
  • Rheumatoid Arthritis

contRAst 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 12), week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 12), week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort)
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
Secondary outcome measures
Change From Baseline in Arthritis Pain VAS at Week 12 (Asia Cohort)
Change From Baseline in Arthritis Pain VAS at Week 12 (Global Cohort)
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
+184 more

Side effects data

From 2022 Phase 3 trial • 550 Patients • NCT04134728
6%
Injection site reaction
5%
Urinary tract infection
3%
Cough
1%
COVID-19 pneumonia
1%
Neutropenia
1%
COVID-19
1%
Sepsis
1%
Post procedural hypotension
1%
Humerus fracture
1%
Alanine aminotransferase increased
1%
Liver abscess
1%
Osteomyelitis bacterial
1%
Basal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK3196165 90mg + csDMARD
GSK3196165 150mg + csDMARD
Sarilumab 200mg + csDMARD
Placebo + csDMARD and GSK3196165 90 mg + csDMARD
Pooled Placebo
Placebo + csDMARD and GSK3196165 150 mg + csDMARD
Placebo + csDMARD and Sarilumab 200 mg + csDMARD

contRAst 2 Trial Design

12Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: GSK3196165 90mg + csDMARD (Global Cohort)Experimental Treatment1 Intervention
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
Group II: GSK3196165 90mg + csDMARD (Asia Cohort)Experimental Treatment1 Intervention
Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
Group III: GSK3196165 150mg + csDMARD (Global Cohort)Experimental Treatment1 Intervention
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
Group IV: GSK3196165 150mg + csDMARD (Asia Cohort)Experimental Treatment1 Intervention
Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
Group V: Tofacitinib 5mg + csDMARD (Asia Cohort)Active Control1 Intervention
Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.
Group VI: Tofacitinib 5mg + csDMARD (Global Cohort)Active Control1 Intervention
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.
Group VII: Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)Placebo Group2 Interventions
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Group VIII: Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)Placebo Group2 Interventions
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Group IX: Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)Placebo Group2 Interventions
Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
Group X: Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)Placebo Group2 Interventions
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Group XI: Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort)Placebo Group2 Interventions
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Group XII: Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort)Placebo Group2 Interventions
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3196165 (Otilimab)
2019
Completed Phase 3
~2090

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,749 Previous Clinical Trials
8,065,664 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,275 Patients Enrolled for Rheumatoid Arthritis
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
168,244 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,142,166 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
155 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What inflammatory diseases does csDMARDs typically target?

"arthritis in young patients, intolerance to methotrexate drugs, and patients that have plateaued in their methotrexate treatment can all be helped by csDMARDs."

Answered by AI

In how many different medical clinics is this trial taking place today?

"The 84 sites for this clinical trial are presently recruiting patients. The locations for the sites are in Grand Blanc, Worcester, Clearwater and other locations. If you enroll, it would be helpful to select the clinic closest to you to reduce travel demands."

Answered by AI

Do csDMARDs have a long history of being safe for human trials?

"CSDMARDs have received a score of 3 from our team at Power. This is because these drugs have reached Phase 3 in clinical trials, meaning that there is both efficacy data and multiple rounds of safety data supporting their use."

Answered by AI

How often are csDMARDs tested in other medical trials?

"There are currently 35 clinical trials being conducted to research csDMARDs. 8 of those trials are in Phase 3. Many of the trials for csDMARDs are based in Shanghai, but there are 882 locations running studies for this treatment worldwide."

Answered by AI

How many individuals are being chosen to participate in this clinical trial?

"This study is not recruiting at this time, according to the latest update on October 17th, 2022. The study was first posted on June 5th, 2019. There are presently 376 trials actively enrolling patients with arthritis, rheumatoid and 35 trials for csDMARDs actively looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
California
Georgia
Michigan
How old are they?
65+
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
2019. "Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03970837.
~302 spots leftby Apr 2025
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