Trial · NCT04333147
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
NCT04333147, Phase 3, Terminated, GlaxoSmithKline; results first posted 2024-02-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA). Trials, record NCT04333147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04333147
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
- NCT number
- NCT04333147
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,916 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Otilimab (GSK3196165), csDMARD(s)
- First posted
- 2020-04-03
- Last updated
- 2024-02-07
- Results first posted
- 2024-02-07
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | 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. |
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Primary | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | 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. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Up to approximately 145 Weeks | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | Baseline (Day 01) and Week 144 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | Baseline (Day 01) and Week 144 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group323
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Otilimab 90 mg | Participants with AEs | 902 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Otilimab 150 mg | Participants with AEs | 931 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Otilimab 90 mg | Participants with SAEs | 123 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Otilimab 150 mg | Participants with SAEs | 114 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Otilimab 90 mg | Participants with AESI | 120 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Otilimab 150 mg | Participants with AESI | 95 | Participants | |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Otilimab 90 mg | -11.9 | Standard Deviation 66.86 | Giga cells per liter (10^9 cells/L) | |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Otilimab 150 mg | -9.7 | Standard Deviation 66.82 | Giga cells per liter (10^9 cells/L) | |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Otilimab 90 mg | -12.5 | Standard Deviation 66.47 | Giga cells per liter (10^9 cells/L) | |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Otilimab 150 mg | -7.6 | Standard Deviation 71.36 | Giga cells per liter (10^9 cells/L) |
1 to 10 of 323Source ClinicalTrials.gov
See all 323 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Otilimab 90 mg | 1,456 | |
| Overall Study | STARTED | Otilimab 150 mg | 1,459 | |
| Overall Study | COMPLETED | Otilimab 90 mg | 0 | |
| Overall Study | COMPLETED | Otilimab 150 mg | 0 | |
| Overall Study | NOT COMPLETED | Otilimab 90 mg | 1,456 | |
| Overall Study | NOT COMPLETED | Otilimab 150 mg | 1,459 |
Source ClinicalTrials.gov
Adverse events380
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Otilimab 90 mg | 141 | 1,456 | 153 |
| other | COVID-19 | Infections and infestations | Otilimab 150 mg | 141 | 1,459 | 148 |
| other | Upper respiratory tract infection | Infections and infestations | Otilimab 90 mg | 65 | 1,456 | 74 |
| other | Upper respiratory tract infection | Infections and infestations | Otilimab 150 mg | 88 | 1,459 | 100 |
| other | Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Otilimab 90 mg | 118 | 1,456 | 158 |
| other | Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Otilimab 150 mg | 129 | 1,459 | 175 |
| serious | Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | Otilimab 90 mg | 0 | 1,456 | 0 |
| serious | Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | Otilimab 150 mg | 1 | 1,459 | 1 |
| serious | Eosinophilia | Blood and lymphatic system disorders | Otilimab 90 mg | 0 | 1,456 | 0 |
| serious | Eosinophilia | Blood and lymphatic system disorders | Otilimab 150 mg | 1 | 1,459 | 1 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Otilimab 90 mg | 10 | 1,456 |
| Total, all-cause mortality | Otilimab 150 mg | 9 | 1,459 |
| Total, other adverse events | Otilimab 90 mg | 279 | 1,456 |
| Total, other adverse events | Otilimab 150 mg | 308 | 1,459 |
| Total, serious adverse events | Otilimab 90 mg | 123 | 1,456 |
| Total, serious adverse events | Otilimab 150 mg | 114 | 1,459 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40044198 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Otilimab 90 mg vs Otilimab 150 mg: Number of Participants With Anti-GSK3196165 Antibodies | Trial comparisons |
| Otilimab 90 mg vs Otilimab 150 mg: deaths from any cause | Trial comparisons |
| Otilimab 90 mg vs Otilimab 150 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04333147
GET https://conductscience.org/api/trials/v1/NCT04333147/registered?page=2