Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- \>=18 years of age
- Has had RA for \>=6 months and was not diagnosed before 16 years of age
- Has active disease, as defined by having both:\*
- \>=6/68 tender/painful joints (tender joint count \[TJC\]), and
- \>=6/66 swollen joints (swollen joint count \[SJC\])
- Has had an inadequate response despite currently taking at least one and at the most two concomitant csDMARDs for at least 12 weeks, from the following:
- Methotrexate (MTX)
- Hydroxychloroquine or chloroquine
- Sulfasalazine
- Leflunomide
- Bucillamine
- Iguratimod
- Tacrolimus
- Has had inadequate response to at least one bDMARD at an approved dose and/or at least one JAK inhibitors at an approved dose. In both cases this may be with or without combination with a csDMARD.
- If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
- Key exclusion criteria:
- Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
- Has received prior treatment with an antagonist of GM-CSF or its receptor.
- Has known infection with human immunodeficiency virus (HIV) or current acute or chronic hepatitis B and/or hepatitis C.
Exclusion
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04134728
Start Date
October 31 2019
End Date
February 1 2022
Last Update
July 17 2023
Active Locations (131)
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1
GSK Investigational Site
Mesa, Arizona, United States, 85210
2
GSK Investigational Site
Phoenix, Arizona, United States, 85032
3
GSK Investigational Site
Sun City, Arizona, United States, 85351
4
GSK Investigational Site
Tucson, Arizona, United States, 85704