Trial · NCT02294058
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
NCT02294058, Phase 3, Completed, Celgene; results first posted 2020-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS). Trials, record NCT02294058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02294058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
- NCT number
- NCT02294058
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,346 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Multiple Sclerosis
- Interventions
- Ozanimod, Interferon beta-1a, Placebo to ozanimod, Placebo to interferon beta-1a
- First posted
- 2014-11-19
- Last updated
- 2020-11-25
- Other registries' IDs
- eudract:2014-002320-27
- Results first posted
- 2020-11-25
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) During the Treatment Period | 12 months | The relapse rate was based on confirmed relapses. 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 relapses divided by the total number of days in the study \* 365.25. ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term. |
| Secondary | Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months | 12 month treatment period; MRI scans were assessed at Month 6 and Month 12 | The 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 treatment period. |
| Secondary | Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 | Month 12 | |
| Secondary | Time to Onset of Disability Progression Confirmed After 3 Months | From first dose to the end of the 12-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 12-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 6 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 Lesion-Free at Month 12 | Month 12 | MRI scans were analyzed by blinded centralized reading facility. |
| Secondary | Percentage of Participants Who Were T2 Lesion-Free at Month 12 | Month 12 | MRI scans were analyzed by blinded centralized reading facility. |
| Secondary | Percent Change From Baseline in Normalized Brain Volume at Month 12 | Baseline to Month 12 | Brain volume (a measure of brain atrophy) was analyzed by MRI. |
| Secondary | Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test | Baseline to Month 12 | 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 12 | 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 outcomesOutcomes11
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) During the Treatment Period | 12 months | The ITT population consisted of all randomized participants who received at least 1 dose of study medication. | relapses/year | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months | 12 month treatment period; MRI scans were assessed at Month 6 and Month 12 | ITT population; participants with non-missing MRI results. | T2 lesions/scan | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 | Month 12 | ITT population; participants with non-missing MRI results. | lesions | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Onset of Disability Progression Confirmed After 3 Months | From first dose to the end of the 12-month treatment period | ITT population | days | MEDIAN |
| SECONDARY | Time to Onset of Disability Progression Confirmed After 6 Months | From first dose to the end of the 12-month treatment period | ITT population | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12 | Month 12 | The ITT population; Participants who were missing the Month 12 MRI data were considered non-responders; ie, as not being lesion-free (non-responder imputation). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were T2 Lesion-Free at Month 12 | Month 12 | The ITT population; participants who were missing the Month 12 MRI data were considered non-responders, ie, as not being lesion-free. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Normalized Brain Volume at Month 12 | Baseline to Month 12 | The ITT population with available MRI data at Baseline and Month 12 | percent change | MEDIAN |
| SECONDARY | Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test | Baseline to Month 12 | The ITT population with available Baseline and Month 12 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 12 | ITT population with available Baseline data; missing post-baseline data were imputed using a mixed-effects regression model (random slope and intercept). | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group69
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) During the Treatment Period | Interferon Beta-1a | 0.350 | 95% Confidence Interval 0.279 to 0.440 | relapses/year | |
| Adjusted Annualized Relapse Rate (ARR) During the Treatment Period | Ozanimod 0.5 mg | 0.241 | 95% Confidence Interval 0.188 to 0.308 | relapses/year | |
| Adjusted Annualized Relapse Rate (ARR) During the Treatment Period | Ozanimod 1 mg | 0.181 | 95% Confidence Interval 0.140 to 0.236 | relapses/year | |
| Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months | Interferon Beta-1a | 2.836 | 95% Confidence Interval 2.331 to 3.451 | T2 lesions/scan | |
| Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months | Ozanimod 0.5 mg | 2.139 | 95% Confidence Interval 1.777 to 2.575 | T2 lesions/scan | |
| Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months | Ozanimod 1 mg | 1.465 | 95% Confidence Interval 1.203 to 1.784 | T2 lesions/scan | |
| Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 | Interferon Beta-1a | 0.433 | 95% Confidence Interval 0.295 to 0.635 | lesions | |
| Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 | Ozanimod 0.5 mg | 0.287 | 95% Confidence Interval 0.197 to 0.418 | lesions | |
| Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 | Ozanimod 1 mg | 0.160 | 95% Confidence Interval 0.106 to 0.242 | 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 69Source ClinicalTrials.gov
See all 69 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 | 448 | |
| Overall Study | STARTED | Ozanimod 0.5 mg | 451 | |
| Overall Study | STARTED | Ozanimod 1 mg | 447 | |
| Overall Study | Safety Population | Interferon Beta-1a | 445 | |
| Overall Study | Safety Population | Ozanimod 0.5 mg | 453 | |
| Overall Study | Safety Population | Ozanimod 1 mg | 448 | |
| Overall Study | COMPLETED | Interferon Beta-1a | 412 | |
| Overall Study | COMPLETED | Ozanimod 0.5 mg | 425 | |
| Overall Study | COMPLETED | Ozanimod 1 mg | 418 | |
| Overall Study | NOT COMPLETED | Interferon Beta-1a | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events129
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 | 227 | 445 | |
| other | Influenza Like Illness | General disorders | Ozanimod 0.5 mg | 18 | 453 | |
| other | Influenza Like Illness | General disorders | Ozanimod 1 mg | 17 | 448 | |
| other | Pyrexia | General disorders | Interferon Beta-1a | 28 | 445 | |
| other | Pyrexia | General disorders | Ozanimod 0.5 mg | 5 | 453 | |
| other | Pyrexia | General disorders | Ozanimod 1 mg | 5 | 448 | |
| other | Nasopharyngitis | Infections and infestations | Interferon Beta-1a | 36 | 445 | |
| other | Nasopharyngitis | Infections and infestations | Ozanimod 0.5 mg | 44 | 453 | |
| other | Nasopharyngitis | Infections and infestations | Ozanimod 1 mg | 30 | 448 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Interferon Beta-1a | 24 | 445 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interferon Beta-1a | ||
| Total, all-cause mortality | Ozanimod 0.5 mg | ||
| Total, all-cause mortality | Ozanimod 1 mg | ||
| Total, other adverse events | Interferon Beta-1a | 273 | 445 |
| Total, other adverse events | Ozanimod 0.5 mg | 88 | 453 |
| Total, other adverse events | Ozanimod 1 mg | 57 | 448 |
| Total, serious adverse events | Interferon Beta-1a | 11 | 445 |
| Total, serious adverse events | Ozanimod 0.5 mg | 16 | 453 |
| Total, serious adverse events | Ozanimod 1 mg | 13 | 448 |
Source ClinicalTrials.gov
Papers3
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.
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