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.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)Primary· Up to approximately 145 Weeks
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.
Participants with AEs
Group
Value
95% CI
Otilimab 90 mg
902
Otilimab 150 mg
931
Participants with SAEs
Group
Value
95% CI
Otilimab 90 mg
123
Otilimab 150 mg
114
Participants with AESI
Group
Value
95% CI
Otilimab 90 mg
120
Otilimab 150 mg
95
Change From Baseline in Hematology Parameter of Platelet Count at Week 24Primary· Baseline (Day 01) and Week 24
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Group
Value
95% CI
Otilimab 90 mg
-11.9
± 66.86
Otilimab 150 mg
-9.7
± 66.82
Change From Baseline in Hematology Parameter of Platelet Count at Week 48Primary· Baseline (Day 01) and Week 48
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Group
Value
95% CI
Otilimab 90 mg
-12.5
± 66.47
Otilimab 150 mg
-7.6
± 71.36
Change From Baseline in Hematology Parameter of Platelet Count at Week 96Primary· Baseline (Day 01) and Week 96
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Group
Value
95% CI
Otilimab 90 mg
-13.8
± 60.72
Otilimab 150 mg
-5.7
± 72.81
Change From Baseline in Hematology Parameter of Platelet Count at Week 144Primary· Baseline (Day 01) and Week 144
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Group
Value
95% CI
Otilimab 90 mg
17.0
± NA
Otilimab 150 mg
-37.5
± 40.31
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24Primary· Baseline (Day 01) and Week 24
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Group
Value
95% CI
Otilimab 90 mg
0.4
± 10.10
Otilimab 150 mg
0.3
± 9.89
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48Primary· Baseline (Day 01) and Week 48
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Group
Value
95% CI
Otilimab 90 mg
-0.5
± 10.38
Otilimab 150 mg
-1.1
± 10.62
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96Primary· Baseline (Day 01) and Week 96
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Group
Value
95% CI
Otilimab 90 mg
1.0
± 11.37
Otilimab 150 mg
1.2
± 10.24
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144Primary· Baseline (Day 01) and Week 144
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Group
Value
95% CI
Otilimab 90 mg
-1.0
± NA
Otilimab 150 mg
2.0
± 2.83
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24Primary· Baseline (Day 01) and Week 24
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Neutrophils
Group
Value
95% CI
Otilimab 90 mg
-0.348
± 2.18
Otilimab 150 mg
-0.390
± 2.13
Lymphocytes
Group
Value
95% CI
Otilimab 90 mg
-0.001
± 0.55
Otilimab 150 mg
-0.012
± 0.55
Monocytes
Group
Value
95% CI
Otilimab 90 mg
0.003
± 0.18
Otilimab 150 mg
0.00
± 0.194
Eosinophils
Group
Value
95% CI
Otilimab 90 mg
0.027
± 0.1623
Otilimab 150 mg
0.022
± 0.171
Basophils
Group
Value
95% CI
Otilimab 90 mg
-0.001
± 0.0405
Otilimab 150 mg
-0.001
± 0.04
Total WBC
Group
Value
95% CI
Otilimab 90 mg
-0.32
± 2.212
Otilimab 150 mg
-0.38
± 2.230
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48Primary· Baseline (Day 01) and Week 48
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Neutrophils
Group
Value
95% CI
Otilimab 90 mg
-0.318
± 2.2215
Otilimab 150 mg
-0.541
± 2.1426
Lymphocytes
Group
Value
95% CI
Otilimab 90 mg
-0.022
± 0.5385
Otilimab 150 mg
-0.051
± 0.5725
Monocytes
Group
Value
95% CI
Otilimab 90 mg
-0.002
± 0.1871
Otilimab 150 mg
-0.013
± 0.2461
Eosinophils
Group
Value
95% CI
Otilimab 90 mg
0.018
± 0.1435
Otilimab 150 mg
0.028
± 0.1844
Basophils
Group
Value
95% CI
Otilimab 90 mg
-0.004
± 0.0391
Otilimab 150 mg
-0.006
± 0.0403
Total WBC
Group
Value
95% CI
Otilimab 90 mg
-0.33
± 2.283
Otilimab 150 mg
-0.58
± 2.262
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96Primary· Baseline (Day 01) and Week 96
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Neutrophils
Group
Value
95% CI
Otilimab 90 mg
-0.243
± 1.8851
Otilimab 150 mg
-0.582
± 2.4346
Lymphocytes
Group
Value
95% CI
Otilimab 90 mg
0.090
± 0.6453
Otilimab 150 mg
0.018
± 0.5816
Monocytes
Group
Value
95% CI
Otilimab 90 mg
-0.042
± 0.2001
Otilimab 150 mg
-0.001
± 0.2035
Eosinophils
Group
Value
95% CI
Otilimab 90 mg
0.025
± 0.1725
Otilimab 150 mg
0.029
± 0.1526
Basophils
Group
Value
95% CI
Otilimab 90 mg
-0.007
± 0.0423
Otilimab 150 mg
-0.013
± 0.0346
Total WBC
Group
Value
95% CI
Otilimab 90 mg
-0.18
± 2.043
Otilimab 150 mg
-0.53
± 2.568
Adverse events — posted to ClinicalTrials.gov
Time frame: All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07176390 — A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
· Phase 2
· recruiting
NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases
· recruiting
NCT06528431 — Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
· Phase 4
· recruiting
NCT06492200 — Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis
· NA
· recruiting
NCT06246123 — A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
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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: 7 February 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/NCT04333147.