Trial · NCT02861014
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
NCT02861014, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT). Trials, record NCT02861014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02861014
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
- NCT number
- NCT02861014
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 681 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Ocrelizumab
- First posted
- 2016-08-10
- Last updated
- 2022-01-27
- Other registries' IDs
- eudract:2015-005597-38
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period | Week 96 | A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan |
| Secondary | Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period | Baseline up to 24 weeks | A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan |
| Secondary | Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period | Baseline up to 48 weeks | A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan |
| Secondary | Time to First Protocol-Defined Event of Disease Activity | Baseline up to 96 Weeks | The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse defined as: Symptoms must persist for \>24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment * 24 weeks confirmed disability progression based on increases in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan. |
| Secondary | Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Baseline, Weeks: 24, 48, 72, 96 | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. |
| Secondary | Absolute Change From Baseline in EDSS Category at Week 96 | Up to Week 96 | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. |
| Secondary | Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96 | Week 96 | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. |
| Secondary | Annualized Protocol-defined Relapse Rate at Week 96 | Week 96 | |
| Secondary | Time to Onset of 24-week Confirmed Disability Progression | Baseline up to 96 Weeks | |
| Secondary | Time to Onset of First Protocol-Defined Relapse | Baseline up to 96 Weeks | A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria: * Symptoms must persist for \>24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) * Symptoms should be preceded by neurological stability for at least 30 days * Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least: * ≥ 0.5 points on EDSS scale * or ≥ 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual * or ≥ 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period | Week 96 | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period | Baseline up to 24 weeks | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period | Baseline up to 48 weeks | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Protocol-Defined Event of Disease Activity | Baseline up to 96 Weeks | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Weeks | MEDIAN |
| SECONDARY | Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Baseline, Weeks: 24, 48, 72, 96 | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Points on scale | MEAN |
| SECONDARY | Absolute Change From Baseline in EDSS Category at Week 96 | Up to Week 96 | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96 | Week 96 | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Percentage of Participants | NUMBER |
| SECONDARY | Annualized Protocol-defined Relapse Rate at Week 96 | Week 96 | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. | Relapses per participant per year | NUMBER |
| SECONDARY | Time to Onset of 24-week Confirmed Disability Progression | Baseline up to 96 Weeks | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Weeks | MEDIAN |
| SECONDARY | Time to Onset of First Protocol-Defined Relapse | Baseline up to 96 Weeks | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Weeks | MEDIAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period | Ocrelizumab | 74.8 | 95% Confidence Interval 71.3 to 78.0 | Percentage of Participants | |
| Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period | Ocrelizumab | 87.1 | 95% Confidence Interval 84.3 to 89.5 | Percentage of Participants | |
| Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period | Ocrelizumab | 82.6 | 95% Confidence Interval 79.5 to 85.4 | Percentage of Participants | |
| Time to First Protocol-Defined Event of Disease Activity | Ocrelizumab | NA | 95% Confidence Interval NA to NA | Weeks | |
| Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Ocrelizumab | Baseline | 2.09 | Standard Deviation 1.06 | Points on scale |
| Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Ocrelizumab | Week 24 | -0.02 | Standard Deviation 0.64 | Points on scale |
| Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Ocrelizumab | Week 48 | 0.01 | Standard Deviation 0.82 | Points on scale |
| Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Ocrelizumab | Week 72 | -0.03 | Standard Deviation 0.85 | Points on scale |
| Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) | Ocrelizumab | Week 96 | -0.01 | Standard Deviation 0.85 | Points on scale |
| Absolute Change From Baseline in EDSS Category at Week 96 | Ocrelizumab | Worsened (>0.5) | 13.4 | Percentage of Participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Analysis | STARTED | Ocrelizumab | 680 | |
| Primary Analysis | COMPLETED | Ocrelizumab | 641 | |
| Primary Analysis | NOT COMPLETED | Ocrelizumab | 39 | |
| Safety Follow-up | STARTED | Ocrelizumab | 64 | |
| Safety Follow-up | COMPLETED | Ocrelizumab | 14 | |
| Safety Follow-up | NOT COMPLETED | Ocrelizumab | 50 |
Source ClinicalTrials.gov
Adverse events164
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 | Ocrelizumab | 210 | 680 | 449 |
| other | NASOPHARYNGITIS | Infections and infestations | Ocrelizumab Safety Follow-up | 11 | 64 | 19 |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Ocrelizumab | 47 | 680 | 56 |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Ocrelizumab Safety Follow-up | 4 | 64 | 4 |
| other | DIARRHOEA | Gastrointestinal disorders | Ocrelizumab | 42 | 680 | 52 |
| other | DIARRHOEA | Gastrointestinal disorders | Ocrelizumab Safety Follow-up | 0 | 64 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Ocrelizumab | 38 | 680 | 40 |
| other | NAUSEA | Gastrointestinal disorders | Ocrelizumab Safety Follow-up | 0 | 64 | 0 |
| other | FATIGUE | General disorders | Ocrelizumab | 67 | 680 | 106 |
| other | FATIGUE | General disorders | Ocrelizumab Safety Follow-up | 0 | 64 | 0 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ocrelizumab | 1 | 680 |
| Total, all-cause mortality | Ocrelizumab Safety Follow-up | 0 | 64 |
| Total, other adverse events | Ocrelizumab | 531 | 680 |
| Total, other adverse events | Ocrelizumab Safety Follow-up | 14 | 64 |
| Total, serious adverse events | Ocrelizumab | 49 | 680 |
| Total, serious adverse events | Ocrelizumab Safety Follow-up | 6 | 64 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ocrelizumab vs Ocrelizumab Safety Follow-up: deaths from any cause | Trial comparisons |
| Ocrelizumab vs Ocrelizumab Safety Follow-up: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
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/NCT02861014
GET https://conductscience.org/api/trials/v1/NCT02861014/registered?page=2