Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
CompletedPhase 3Results postedLast updated 27 March 2024
What this trial tests
Phase 3 trial testing GSK3196165 (Otilimab) in Arthritis, Rheumatoid in 1,537 participants. Completed in 16 August 2022.
18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving 20 Percentage (%) Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With PlaceboPrimary· Week 12
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 whe
Group
Value
95% CI
GSK3196165 90mg + MTX
54.7
GSK3196165 150mg + MTX
50.9
Tofacitinib 5mg + MTX
63.6
Pooled Placebo
42.7
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12Secondary· Week 12
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low
Group
Value
95% CI
GSK3196165 90mg + MTX
20.9
GSK3196165 150mg + MTX
19.8
Tofacitinib 5mg + MTX
32.5
Pooled Placebo
13.9
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12Secondary· Baseline (Day 1) and Week 12
Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0=least difficulty and 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Base
Group
Value
95% CI
GSK3196165 90mg + MTX
-0.46
± 0.025
GSK3196165 150mg + MTX
-0.38
± 0.024
Tofacitinib 5mg + MTX
-0.5
± 0.034
Pooled Placebo
-0.27
± 0.034
Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24 (Non-Inferiority Versus Tofacitinib)Secondary· Week 24
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 whe
Group
Value
95% CI
GSK3196165 90mg + MTX
63.9
GSK3196165 150mg + MTX
61.3
Tofacitinib 5mg + MTX
74.4
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria (ACR50/70) at Week 24 and ACR 20/50/70 at and Week 52 for Treatment Arms Who Started Study Intervention From Day 1Secondary· Week 24 and Week 52
ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20%/50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst\], Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ- DI)
ACR20, Week 52
Group
Value
95% CI
GSK3196165 90mg + MTX
63.9
GSK3196165 150mg + MTX
61.1
Tofacitinib 5mg + MTX
75.8
ACR50, Week 24
Group
Value
95% CI
GSK3196165 90mg + MTX
31.4
GSK3196165 150mg + MTX
29.1
Tofacitinib 5mg + MTX
46.7
ACR50, Week 52
Group
Value
95% CI
GSK3196165 90mg + MTX
35.0
GSK3196165 150mg + MTX
34.2
Tofacitinib 5mg + MTX
48.4
ACR70, Week 24
Group
Value
95% CI
GSK3196165 90mg + MTX
12.5
GSK3196165 150mg + MTX
10.1
Tofacitinib 5mg + MTX
25.1
ACR70, Week 52
Group
Value
95% CI
GSK3196165 90mg + MTX
16.7
GSK3196165 150mg + MTX
14.4
Tofacitinib 5mg + MTX
26.9
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched ArmsSecondary· Week 24 and Week 52
ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20%/50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst\], Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ- DI)
ACR20, Week 24
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
56.7
Placebo + MTX and GSK3196165 150mg + MTX
71.2
Placebo + MTX and Tofacitinib 5mg + MTX
69.9
ACR20, Week 52
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
70.5
Placebo + MTX and GSK3196165 150mg + MTX
67.8
Placebo + MTX and Tofacitinib 5mg + MTX
84.6
ACR50, Week 24
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
37.0
Placebo + MTX and GSK3196165 150mg + MTX
35.0
Placebo + MTX and Tofacitinib 5mg + MTX
40.7
ACR50, Week 52
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
28.6
Placebo + MTX and GSK3196165 150mg + MTX
42.5
Placebo + MTX and Tofacitinib 5mg + MTX
50.7
ACR70, Week 24
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
7.9
Placebo + MTX and GSK3196165 150mg + MTX
15.0
Placebo + MTX and Tofacitinib 5mg + MTX
19.6
ACR70, Week 52
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
10.3
Placebo + MTX and GSK3196165 150mg + MTX
20.2
Placebo + MTX and Tofacitinib 5mg + MTX
25.8
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1Secondary· Week 24 and Week 52
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low
Week 24
Group
Value
95% CI
GSK3196165 90mg + MTX
29.9
GSK3196165 150mg + MTX
29.8
Tofacitinib 5mg + MTX
45.9
Week 52
Group
Value
95% CI
GSK3196165 90mg + MTX
35.5
GSK3196165 150mg + MTX
37.1
Tofacitinib 5mg + MTX
51.7
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched ArmsSecondary· Week 24 and Week 52
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low
Week 24
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
32.9
Placebo + MTX and GSK3196165 150mg + MTX
37.4
Placebo + MTX and Tofacitinib 5mg + MTX
45.8
Week 52
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
38.5
Placebo + MTX and GSK3196165 150mg + MTX
44
Placebo + MTX and Tofacitinib 5mg + MTX
52.4
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12Secondary· Week 12
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI
Group
Value
95% CI
GSK3196165 90mg + MTX
3.8
GSK3196165 150mg + MTX
2.4
Tofacitinib 5mg + MTX
5.8
Pooled Placebo
1.0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1Secondary· Week 24 and Week 52
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI
Week 24
Group
Value
95% CI
GSK3196165 90mg + MTX
6.1
GSK3196165 150mg + MTX
5.2
Tofacitinib 5mg + MTX
12.1
Week 52
Group
Value
95% CI
GSK3196165 90mg + MTX
9.4
GSK3196165 150mg + MTX
4.4
Tofacitinib 5mg + MTX
15.1
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched ArmsSecondary· Week 24 and Week 52
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI
Week 24
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
4.4
Placebo + MTX and GSK3196165 150mg + MTX
8.4
Placebo + MTX and Tofacitinib 5mg + MTX
6.4
Week 52
Group
Value
95% CI
Placebo + MTX and GSK3196165 90mg + MTX
4.6
Placebo + MTX and GSK3196165 150mg + MTX
9.6
Placebo + MTX and Tofacitinib 5mg + MTX
11.1
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria (ACR50/70) at Week 12Secondary· Week 12
ACR50/70 is calculated as a 50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from
ACR50, Week 12
Group
Value
95% CI
GSK3196165 90mg + MTX
23.3
GSK3196165 150mg + MTX
20.0
Tofacitinib 5mg + MTX
34.1
Pooled Placebo
12.2
ACR70, Week 12
Group
Value
95% CI
GSK3196165 90mg + MTX
8.5
GSK3196165 150mg + MTX
6.1
Tofacitinib 5mg + MTX
13.9
Pooled Placebo
3.5
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5mg + MTX collected during the timeframe Week 12 to Week 59. GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5mg + MTX collected during the timeframe Week 0 to Week 59..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GSK3196165 90mg + MTX
Serious: 33/513 (6%)
Deaths: 2/513
GSK3196165 150mg + MTX
Serious: 39/510 (8%)
Deaths: 7/510
Tofacitinib 5mg + MTX
Serious: 23/273 (8%)
Deaths: 3/273
Pooled Placebo
Serious: 8/241 (3%)
Deaths: 1/241
Placebo + MTX and GSK3196165 90mg + MTX
Serious: 8/80 (10%)
Deaths: 0/80
Placebo + MTX and GSK3196165 150mg + MTX
Serious: 9/82 (11%)
Deaths: 1/82
Placebo + MTX and Tofacitinib 5mg + MTX
Serious: 5/68 (7%)
Deaths: 0/68
Serious adverse events (109 terms)
Reaction
System
GSK3196165 90mg + MTX
GSK3196165 150mg + MTX
Tofacitinib 5mg + MTX
Pooled Placebo
Placebo + MTX and GSK31961…
Placebo + MTX and GSK31961…
Placebo + MTX and Tofaciti…
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This study \[contRAst 1 (201790: NCT03980483)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. 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 6:6:3:1:1:1 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 MTX. Participants who, in investigator's 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04134728 — Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Ac
· Phase 3
· completed
NCT03970837 — Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheu
· Phase 3
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 27 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03980483.