GSK 209564 contRAst-X
Research type
Research Study
Full title
A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.
IRAS ID
279713
Contact name
Peter Charles Taylor
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2019-000878-30
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a long-term safety and efficacy study. The participants in this study will be adults with rheumatoid arthritis (RA) who have completed the treatment phase of a qualifying GSK3196165 – also known as “otilimab” - clinical study (including phase 3 studies contRAst 1 (201790 - IRAS ID266684), contRAst 2 (201791 - IRAS ID 269798) and contRAst 3 (202018 - IRAS ID 269887) and who, in the investigator’s judgement will benefit from extended treatment with otilimab. The primary aim of this study is to provide long-term safety data for otilimab, dosed at 90 mg or 150 mg every week.
It is anticipated that approximately 3000 participants from the qualifying studies already planned (201790, 201791 and 202018) may be eligible to participate in this long-term extension study. This number may increase if the number of qualifying studies increases. All subjects will be considered evaluable.
Participants will be assigned to receive otilimab 90 mg or 150 mg weekly SC (subcutaneous - under the skin) injection as follows and will continue to receive the same background conventional synthetic disease modifying antirheumatic drug(s) (csDMARD) treatment as they received in their qualifying study. However, if clinically indicated, a participant's background csDMARD(s) dose may be changed, including dose reduction/discontinuation per the guidance within protocol.
It is expected that an autoinjector (AI) device will become available to supplement/replace the pre-filled syringes (PFS). When the AI device becomes available, a sub-study of approximately 200 new participants who join the extension study at this time, will examine AI device usability and steady state PK.REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0172
Date of REC Opinion
28 Apr 2020
REC opinion
Favourable Opinion