Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03970837
Status:
TERMINATED
Last Update Posted:
2023-11-30
First Post:
2019-05-16
Brief Title:
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic csBiologic b Disease Modifying Anti-rheumatic Drugs DMARDs
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A 52-week Phase 3 Multicentre Randomised Double Blind Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only Asia cohort is early terminatedLimited efficacy demonstrated in the contRAst program does not support a suitable benefitrisk profile for otilimab as a potential treatment for RA GSK has decided not to progress with regulatory submissions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
contRAst 2
Brief Summary:
This study contRAst 2 201791 NCT03970837 is a phase 3 randomized multicenter double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARDs for the treatment of adult participants with moderate to severe active rheumatoid arthritis RA who have had an inadequate response to csDMARDs or bDMARDs The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 663111 to receive GSK3196165 150 milligrams mg subcutaneous SC weekly GSK3196165 90 mg SC weekly tofacitinib capsules cap 5 mg twice a day or placebo three arms each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment respectively all in combination with csDMARDs Participants who in investigators judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study contRAst X 209564 NCT04333147 For those participants who do not continue into the long term-extension study there will be an 8 week safety follow-up visit following the treatment phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None