Trial · NCT03120949
Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
NCT03120949, Phase 3, Completed, R-Pharm International, LLC; results first posted 2022-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis. Trials, record NCT03120949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03120949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
- NCT number
- NCT03120949
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,106 participants, actual
- Lead sponsor
- R-Pharm International, LLC
- Conditions
- Rheumatoid Arthritis
- Interventions
- Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w, Concomitant treatment
- First posted
- 2017-04-19
- Last updated
- 2023-10-12
- Other registries' IDs
- eudract:2015-005309-35
- Results first posted
- 2022-06-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | up to Week 126 | Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term |
| Primary | Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population) | up to Week 126 | Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included. |
| Primary | Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI) | up to Week 126 | |
| Primary | Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment | up to Week 126 | |
| Primary | Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure | up to Week 126 | Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. |
| Primary | Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure | up to Week 126 | Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. |
| Primary | Incidence Rate of Treatment Emergent AESIs (Safety Population) | up to Week 126 | Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. |
| Secondary | American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures: * Patient Global Assessment of Disease Activity (VAS) * Patient Assessment of Pain (VAS) * HAQ-DI * Physician Global Assessment (VAS) * Level of acute phase reactant (CRP) |
| Secondary | American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: * Patient Global Assessment of Disease Activity (VAS) * Patient Assessment of Pain (VAS) * HAQ-DI * Physician Global Assessment (VAS) * Level of acute phase reactant (CRP) |
| Secondary | American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures: * Patient Global Assessment of Disease Activity (VAS) * Patient Assessment of Pain (VAS) * HAQ-DI * Physician Global Assessment (VAS) * Level of acute phase reactant (CRP) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | up to Week 126 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population) | up to Week 126 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI) | up to Week 126 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment | up to Week 126 | Safety Population (3 Subjects discontinued treatment due to an AE but they did not have an AE that led to treatment discontinuation.) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure | up to Week 126 | subjects per 100 subject-years | NUMBER | |
| PRIMARY | Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure | up to Week 126 | subjects per 100 subject-years | NUMBER | |
| PRIMARY | Incidence Rate of Treatment Emergent AESIs (Safety Population) | up to Week 126 | An AE is defined as treatment-emergent under a given study treatment, if AE's onset date is on or after the date of first dose the corresponding treatment and prior to initiation of the next study treatment, if any. | subjects per 100 subject-years | NUMBER |
| SECONDARY | American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82 | up to Week 82 | mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group690
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 1: OKZ 64 mg q4w + MTX | Infections and infestations | 401 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 2: OKZ 64 mg q2w + MTX | Infections and infestations | 408 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 1: OKZ 64 mg q4w + MTX | Infections and infestations: Nasopharyngitis | 71 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 2: OKZ 64 mg q2w + MTX | Infections and infestations: Nasopharyngitis | 87 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 1: OKZ 64 mg q4w + MTX | Infections and infestations: Upper respiratory tract infection | 59 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 2: OKZ 64 mg q2w + MTX | Infections and infestations: Upper respiratory tract infection | 67 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 1: OKZ 64 mg q4w + MTX | Infections and infestations: Bronchitis | 59 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 2: OKZ 64 mg q2w + MTX | Infections and infestations: Bronchitis | 45 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 1: OKZ 64 mg q4w + MTX | Investigations | 284 | Participants | |
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Treatment Arm 2: OKZ 64 mg q2w + MTX | Investigations | 290 | Participants |
1 to 10 of 690Source ClinicalTrials.gov
See all 690 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm 1: OKZ 64 mg q4w + MTX | 1,058 | |
| Overall Study | STARTED | Treatment Arm 2: OKZ 64 mg q2w + MTX | 1,047 | |
| Overall Study | mITT | Treatment Arm 1: OKZ 64 mg q4w + MTX | 1,057 | |
| Overall Study | mITT | Treatment Arm 2: OKZ 64 mg q2w + MTX | 1,047 | |
| Overall Study | Safety Population | Treatment Arm 1: OKZ 64 mg q4w + MTX | 1,043 | |
| Overall Study | Safety Population | Treatment Arm 2: OKZ 64 mg q2w + MTX | 1,061 | |
| Overall Study | COMPLETED | Treatment Arm 1: OKZ 64 mg q4w + MTX | 830 | |
| Overall Study | COMPLETED | Treatment Arm 2: OKZ 64 mg q2w + MTX | 844 | |
| Overall Study | NOT COMPLETED | Treatment Arm 1: OKZ 64 mg q4w + MTX | 228 | |
| Overall Study | NOT COMPLETED | Treatment Arm 2: OKZ 64 mg q2w + MTX | 203 |
Source ClinicalTrials.gov
Adverse events430
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 | Nasopharyngitis | Infections and infestations | Treatment Arm 1: OKZ 64 mg q4w + MTX | 71 | 1,043 | 90 |
| other | Nasopharyngitis | Infections and infestations | Treatment Arm 2: OKZ 64 mg q2w + MTX | 87 | 1,061 | 108 |
| other | Upper respiratory tract infection | Infections and infestations | Treatment Arm 1: OKZ 64 mg q4w + MTX | 59 | 1,043 | 70 |
| other | Upper respiratory tract infection | Infections and infestations | Treatment Arm 2: OKZ 64 mg q2w + MTX | 67 | 1,061 | 84 |
| other | Bronchitis | Infections and infestations | Treatment Arm 1: OKZ 64 mg q4w + MTX | 59 | 1,043 | 66 |
| other | Bronchitis | Infections and infestations | Treatment Arm 2: OKZ 64 mg q2w + MTX | 45 | 1,061 | 51 |
| other | Alanine aminotransferase increased | Investigations | Treatment Arm 1: OKZ 64 mg q4w + MTX | 95 | 1,043 | 156 |
| other | Alanine aminotransferase increased | Investigations | Treatment Arm 2: OKZ 64 mg q2w + MTX | 115 | 1,061 | 194 |
| other | Aspartate aminotransferase increased | Investigations | Treatment Arm 1: OKZ 64 mg q4w + MTX | 52 | 1,043 | 80 |
| other | Aspartate aminotransferase increased | Investigations | Treatment Arm 2: OKZ 64 mg q2w + MTX | 63 | 1,061 | 94 |
1 to 10 of 430Source ClinicalTrials.gov
See all 430 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm 1: OKZ 64 mg q4w + MTX | 13 | 1,043 |
| Total, all-cause mortality | Treatment Arm 2: OKZ 64 mg q2w + MTX | 13 | 1,061 |
| Total, other adverse events | Treatment Arm 1: OKZ 64 mg q4w + MTX | 356 | 1,043 |
| Total, other adverse events | Treatment Arm 2: OKZ 64 mg q2w + MTX | 386 | 1,061 |
| Total, serious adverse events | Treatment Arm 1: OKZ 64 mg q4w + MTX | 129 | 1,043 |
| Total, serious adverse events | Treatment Arm 2: OKZ 64 mg q2w + MTX | 120 | 1,061 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42142212 | 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 |
|---|---|
| Treatment Arm 1: OKZ 64 mg q4w + MTX vs Treatment Arm 2: OKZ 64 mg q2w + MTX: Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment | Trial comparisons |
| Treatment Arm 1: OKZ 64 mg q4w + MTX vs Treatment Arm 2: OKZ 64 mg q2w + MTX: deaths from any cause | Trial comparisons |
| Treatment Arm 1: OKZ 64 mg q4w + MTX vs Treatment Arm 2: OKZ 64 mg q2w + MTX: 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/NCT03120949
GET https://conductscience.org/api/trials/v1/NCT03120949/registered?page=2