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Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

NCT04333147 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2916

Last updated 2024-02-07

Study results available
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Summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X \[209564: NCT04333147\]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) \[csDMARD(s)\] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Conditions

  • Arthritis, Rheumatoid

Interventions

BIOLOGICAL

Otilimab (GSK3196165)

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

DRUG

csDMARD(s)

Stable dose of csDMARD(s) as standard of care (SoC).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2023-02-24
Completion
2023-02-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • India
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333147 on ClinicalTrials.gov