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Monoclonal Antibodies

GSK3196165 150mg + MTX for Rheumatoid Arthritis (contRAst 1 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
Key inclusion criteria
>=18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 12), week 24 and week 52
Awards & highlights

contRAst 1 Trial Summary

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

Eligible Conditions
  • Rheumatoid Arthritis

contRAst 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

contRAst 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline 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 Achieving 20 Percentage (%) Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo
Secondary outcome measures
Change From Baseline in Arthritis Pain VAS at Week 12
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
+94 more

Side effects data

From 2022 Phase 3 trial • 550 Patients • NCT04134728
11%
Injection site reaction
7%
Neutropenia
6%
Alanine aminotransferase increased
4%
Urinary tract infection
1%
Aspartate aminotransferase increased
1%
Gilbert's syndrome
1%
Atrial fibrillation
1%
Obstructive pancreatitis
1%
Drowning
1%
COVID-19 pneumonia
1%
Sciatica
1%
Peripheral arterial occlusive disease
1%
Cough
1%
Rectal cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Placebo
Sarilumab 200mg + csDMARD
Placebo + csDMARD and GSK3196165 150 mg + csDMARD
Placebo + csDMARD and GSK3196165 90 mg + csDMARD
GSK3196165 90mg + csDMARD
GSK3196165 150mg + csDMARD
Placebo + csDMARD and Sarilumab 200 mg + csDMARD

contRAst 1 Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: GSK3196165 90mg + MTXExperimental Treatment1 Intervention
Participants received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with methotrexate (MTX).
Group II: GSK3196165 150mg + MTXExperimental Treatment1 Intervention
Participants received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with MTX.
Group III: Tofacitinib 5mg + MTXActive Control1 Intervention
Participants received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with MTX plus placebo injection weekly to maintain the blind for 52 weeks.
Group IV: Placebo + MTX and Tofacitinib 5mg + MTXPlacebo Group2 Interventions
Participants received Placebo capsule weekly in combination with MTX for 12 weeks. At Week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with MTX plus placebo injection to maintain the blind for 52 weeks.
Group V: Placebo + MTX and GSK3196165 90mg + MTXPlacebo Group2 Interventions
Participants received Placebo weekly SC injection in combination with MTX for 12 weeks. At Week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with MTX until Week 52.
Group VI: Placebo + MTX and GSK3196165 150mg + MTXPlacebo Group2 Interventions
Participants received Placebo weekly SC injection in combination with MTX for 12 weeks. At Week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with MTX until Week 52.
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
4,745 Previous Clinical Trials
8,065,485 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,275 Patients Enrolled for Rheumatoid Arthritis
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
168,471 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,142,441 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.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~263 spots leftby Mar 2025