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Monoclonal Antibodies

csDMARD(s) for Rheumatoid Arthritis (contRAst X 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 week 24, 48, 96 and 144
Awards & highlights

contRAst X Trial Summary

This trial is studying the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years in adults with RA.

Eligible Conditions
  • Rheumatoid Arthritis

contRAst X Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24, 48, 96 and 144
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24, 48, 96 and 144 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
+23 more
Secondary outcome measures
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Absolute Values SF-36 Domain Scores
Absolute Values SF-36 Physical Component Scores (PCS)
+13 more

contRAst X Trial Design

2Treatment groups
Experimental Treatment
Group I: Otilimab 90 mgExperimental Treatment2 Interventions
Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.
Group II: Otilimab 150 mgExperimental Treatment2 Interventions
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,064,536 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,275 Patients Enrolled for Rheumatoid Arthritis
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
167,092 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,141,014 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.

To what extent do csDMARD(s) pose a threat to people's safety?

"CsDMARD(s) have been studied in Phase 3 clinical trials, so there is some efficacy data available as well as multiple rounds of safety data. We rate the safety of csDMARD(s) as a 3."

Answered by AI

How many people are currently trialing this medication?

"Correct. The clinical trial is currently recruiting patients, as stated on clinicaltrials.gov. This study was posted on May 12th, 2020 and was last updated on July 21st, 2020. They are looking for 3000 patients from 69 different sites."

Answered by AI

Could you please compare and contrast other similar medical studies involving csDMARD(s)?

"The first clinical trial for csDMARD(s) was in 2019 at GSK Investigational Site. To date, there have been 9 completed clinical trials and 2 active studies. A high concentration of these studies are based in Vandalia, Ohio."

Answered by AI

Does this trial break new ground for research in this area?

"At this moment in time, there are 2 ongoing studies for csDMARD(s) in 27 countries and 164 cities. The first study took place in 2019 and was completed successfully in the Phase 3 drug approval stage. GlaxoSmithKline sponsored the study which involved 1,764 patients. In the years since 2019, a total of 9 trials have been completed."

Answered by AI

What is the main goals of this research?

"The purpose of this trial is to monitor the incidence of adverse events, serious adverse events, and adverse events of special interest over a Baseline period and up to 4 years. Additionally, the study aims to assess secondary outcomes like the absolute values of DAS28-CRP at Week 24, the proportion of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=10) at Week 24, and the absolute values of arthritis pain VAS at Week 48 and every 48 weeks thereafter."

Answered by AI

Are people still enrolling in this research project?

"That is correct. The online clinical trials registry indicates that this research is presently looking for volunteers. The listing was created on May 12th, 2020 and was updated on July 21st, 2022. 69 hospitals or clinics around the world are recruiting 3000 individuals in total."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
Other
Arizona
How old are they?
65+
18 - 65
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have pain all over my body. Over the counter meds provided little relief.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
2020. "Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04333147.
~593 spots leftby Apr 2025
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