Trial · NCT02047734
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
NCT02047734, Phase 3, Completed, Celgene; results first posted 2021-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis. Trials, record NCT02047734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02047734
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
- NCT number
- NCT02047734
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,320 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Ozanimod, Ozanimod placebo, Interferon beta-1a, Interferon beta-1a placebo
- First posted
- 2014-01-28
- Last updated
- 2021-02-11
- Other registries' IDs
- eudract:2012-002714-40
- Results first posted
- 2021-02-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 | At the end of month 24 | A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study \* 365.25. ARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term. |
| Secondary | Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months | 24 month treatment period; MRI scans were performed at Months 12 and 24 | The adjusted mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since Baseline over 24 months. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. The adjusted mean per scan over 24 months was based based on a negative binomial regression model using observed data, adjusted for region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions. The natural log transformation of the number of available MRI scans over 24 months is used as an offset term. |
| Secondary | Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 | Month 24 | MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. The number of gadolinium-enhancing (GdE) lesions at 24 months was analyzed based on observed data using a negative binomial regression model adjusted for region (Eastern Europe vs Rest of World), Baseline age, and Baseline number of GdE lesions, with natural log transformation of number of available MRI scans over 24 months as an offset term (1 scan for per participant). |
| Secondary | Time to Onset of Disability Progression Confirmed After 3 Months | From first dose to the end of the 24-month treatment period | EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present. The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments. Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later. |
| Secondary | Time to Onset of Disability Progression Confirmed After 6 Months | From first dose to the end of the 24-month treatment period | EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present. The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments. Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later. |
| Secondary | Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24 | Month 24 | Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions at the Month 24 MRI scan. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. |
| Secondary | Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24 | Month 24 | MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. |
| Secondary | Percent Change From Baseline in Normalized Brain Volume to Month 24 | Baseline and Month 24 | Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes. |
| Secondary | Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test | Baseline to Month 24 | The MSFC-LCLA is a battery including the following 4 individual scales: * Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds * 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function * Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability * Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity, charts are scored according to the number of letters that are identified correctly Z-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A Z-score represents the number of standard deviations a patient's test result is higher (Z \> 0) or lower (Z \< 0) than the average test result (Z = 0) of the reference population. A positive change indicates improvement. |
| Secondary | Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores | Baseline to Month 24 | The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures. The two summary scores - physical health and mental health - are derived from a weighted combination of scale scores. The physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress. The mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function. Each composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 | At the end of month 24 | The ITT population included all randomized participants who received at least 1 dose of study drug; participants were analyzed according to the treatment they were randomized to receive and not according to what they actually received, if different. | relapses/year | NUMBER |
| SECONDARY | Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months | 24 month treatment period; MRI scans were performed at Months 12 and 24 | ITT Population included all randomized participants who received at least 1 dose of study drug. Includes participants with non-missing MRI results. | lesions/scan | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 | Month 24 | The ITT population consisted of all randomized participants who received at least 1 dose of study medication. Includes participants with non-missing GdE MRI results at Month 24. | lesions | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Onset of Disability Progression Confirmed After 3 Months | From first dose to the end of the 24-month treatment period | The ITT population consisted of all randomized participants who received at least 1 dose of study medication. | days | MEDIAN |
| SECONDARY | Time to Onset of Disability Progression Confirmed After 6 Months | From first dose to the end of the 24-month treatment period | The ITT population consisted of all randomized participants who received at least 1 dose of study medication. | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24 | Month 24 | ITT population included all randomized participants who received at least 1 dose of study drug; participants with missing data at Month 24 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24 | Month 24 | The ITT population consisted of all randomized participants who received at least 1 dose of study medication; Participants with missing data at Month 24 were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Normalized Brain Volume to Month 24 | Baseline and Month 24 | ITT Population; last observation carried forward was used for participants with missing data at Month 24 (only post-baseline MRI scans were carried forward) | percent change | MEAN |
| SECONDARY | Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test | Baseline to Month 24 | The ITT population with available MSFC Z-scores | Z-score | MEAN |
| SECONDARY | Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores | Baseline to Month 24 | The ITT population consisted of all randomized participants who received at least 1 dose of study medication. Missing data were imputed using a mixed-effects regression model. | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 | Interferon Beta-1a | 0.276 | 95% Confidence Interval 0.234 to 0.324 | relapses/year | |
| Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 | Ozanimod 0.5 mg | 0.218 | 95% Confidence Interval 0.183 to 0.259 | relapses/year | |
| Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 | Ozanimod 1 mg | 0.172 | 95% Confidence Interval 0.142 to 0.208 | relapses/year | |
| Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months | Interferon Beta-1a | 3.183 | 95% Confidence Interval 2.640 to 3.838 | lesions/scan | |
| Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months | Ozanimod 0.5 mg | 2.092 | 95% Confidence Interval 1.741 to 2.514 | lesions/scan | |
| Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months | Ozanimod 1 mg | 1.835 | 95% Confidence Interval 1.523 to 2.211 | lesions/scan | |
| Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 | Interferon Beta-1a | 0.373 | 95% Confidence Interval 0.256 to 0.543 | lesions | |
| Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 | Ozanimod 0.5 mg | 0.197 | 95% Confidence Interval 0.131 to 0.296 | lesions | |
| Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24 | Ozanimod 1 mg | 0.176 | 95% Confidence Interval 0.116 to 0.266 | lesions | |
| Time to Onset of Disability Progression Confirmed After 3 Months | Interferon Beta-1a | NA | 95% Confidence Interval NA to NA | days |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Interferon Beta-1a (IFN β-1a) | 443 | |
| Overall Study | STARTED | Ozanimod 0.5 mg | 443 | |
| Overall Study | STARTED | Ozanimod 1 mg | 434 | |
| Overall Study | Received Treatment | Interferon Beta-1a (IFN β-1a) | 441 | |
| Overall Study | Received Treatment | Ozanimod 0.5 mg | 439 | |
| Overall Study | Received Treatment | Ozanimod 1 mg | 433 | |
| Overall Study | COMPLETED | Interferon Beta-1a (IFN β-1a) | 376 | |
| Overall Study | COMPLETED | Ozanimod 0.5 mg | 374 | |
| Overall Study | COMPLETED | Ozanimod 1 mg | 388 | |
| Overall Study | NOT COMPLETED | Interferon Beta-1a (IFN β-1a) | 67 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events294
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 | Influenza Like Illness | General disorders | Interferon Beta-1a | 215 | 440 | |
| other | Influenza Like Illness | General disorders | Ozanimod 0.5 mg | 26 | 439 | |
| other | Influenza Like Illness | General disorders | Ozanimod 1 mg | 27 | 434 | |
| other | Pyrexia | General disorders | Interferon Beta-1a | 27 | 440 | |
| other | Pyrexia | General disorders | Ozanimod 0.5 mg | 12 | 439 | |
| other | Pyrexia | General disorders | Ozanimod 1 mg | 10 | 434 | |
| other | Nasopharyngitis | Infections and infestations | Interferon Beta-1a | 48 | 440 | |
| other | Nasopharyngitis | Infections and infestations | Ozanimod 0.5 mg | 59 | 439 | |
| other | Nasopharyngitis | Infections and infestations | Ozanimod 1 mg | 68 | 434 | |
| other | Pharyngitis | Infections and infestations | Interferon Beta-1a | 15 | 440 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interferon Beta-1a | 0 | 440 |
| Total, all-cause mortality | Ozanimod 0.5 mg | 1 | 439 |
| Total, all-cause mortality | Ozanimod 1 mg | 0 | 434 |
| Total, other adverse events | Interferon Beta-1a | 275 | 440 |
| Total, other adverse events | Ozanimod 0.5 mg | 185 | 439 |
| Total, other adverse events | Ozanimod 1 mg | 199 | 434 |
| Total, serious adverse events | Interferon Beta-1a | 28 | 440 |
| Total, serious adverse events | Ozanimod 0.5 mg | 31 | 439 |
| Total, serious adverse events | Ozanimod 1 mg | 28 | 434 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02047734
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