Trial · NCT00289978
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
NCT00289978, Phase 3, Completed, Novartis; results first posted 2011-03-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis. Trials, record NCT00289978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00289978
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
- NCT number
- NCT00289978
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,272 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- Fingolimod 1.25 mg, Fingolimod 0.5 mg, Placebo
- First posted
- 2006-02-10
- Last updated
- 2012-04-11
- Results first posted
- 2011-03-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated Annualized Aggregate Relapse Rate (ARR) | Baseline to end of study (Month 24) | The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25. |
| Secondary | Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) | Baseline to end of study (Month 24) | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method. |
| Secondary | Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline | Baseline to end of study (Month 24) | The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estimated Annualized Aggregate Relapse Rate (ARR) | Baseline to end of study (Month 24) | This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug. | Relapses per year | NUMBER |
| SECONDARY | Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) | Baseline to end of study (Month 24) | Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline | Baseline to end of study (Month 24) | Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication. | T2 lesions | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Estimated Annualized Aggregate Relapse Rate (ARR) | Fingolimod 1.25 mg | 0.16 | 95% Confidence Interval 0.13 to 0.19 | Relapses per year | |
| Estimated Annualized Aggregate Relapse Rate (ARR) | Fingolimod 0.5 mg | 0.18 | 95% Confidence Interval 0.15 to 0.22 | Relapses per year | |
| Estimated Annualized Aggregate Relapse Rate (ARR) | Placebo | 0.40 | 95% Confidence Interval 0.34 to 0.47 | Relapses per year | |
| Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) | Fingolimod 1.25 mg | 83.4 | 95% Confidence Interval 1.87 | Percentage of participants | |
| Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) | Fingolimod 0.5 mg | 82.3 | 95% Confidence Interval 1.89 | Percentage of participants | |
| Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) | Placebo | 75.9 | 95% Confidence Interval 2.17 | Percentage of participants | |
| Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline | Fingolimod 1.25 mg | 2.5 | Standard Deviation 5.52 | T2 lesions | |
| Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline | Fingolimod 0.5 mg | 2.5 | Standard Deviation 7.19 | T2 lesions | |
| Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline | Placebo | 9.8 | Standard Deviation 13.17 | T2 lesions |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod 1.25 mg | 429 | |
| Overall Study | STARTED | Fingolimod 0.5 mg | 425 | |
| Overall Study | STARTED | Placebo | 418 | |
| Overall Study | COMPLETED | Fingolimod 1.25 mg | 332 | |
| Overall Study | COMPLETED | Fingolimod 0.5 mg | 369 | |
| Overall Study | COMPLETED | Placebo | 332 | |
| Overall Study | NOT COMPLETED | Fingolimod 1.25 mg | 97 | |
| Overall Study | NOT COMPLETED | Fingolimod 0.5 mg | 56 | |
| Overall Study | NOT COMPLETED | Placebo | 86 |
Source ClinicalTrials.gov
Adverse events549
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 | Vertigo | Ear and labyrinth disorders | Fingolimod 1.25 mg | 18 | 429 | |
| other | Vertigo | Ear and labyrinth disorders | Fingolimod 0.5 mg | 18 | 425 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 21 | 418 | |
| other | Diarrhoea | Gastrointestinal disorders | Fingolimod 1.25 mg | 40 | 429 | |
| other | Diarrhoea | Gastrointestinal disorders | Fingolimod 0.5 mg | 50 | 425 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 30 | 418 | |
| other | Nausea | Gastrointestinal disorders | Fingolimod 1.25 mg | 38 | 429 | |
| other | Nausea | Gastrointestinal disorders | Fingolimod 0.5 mg | 38 | 425 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 36 | 418 | |
| other | Fatigue | General disorders | Fingolimod 1.25 mg | 46 | 429 |
1 to 10 of 549Source ClinicalTrials.gov
See all 549 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod 1.25 mg | ||
| Total, all-cause mortality | Fingolimod 0.5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Fingolimod 1.25 mg | 346 | 429 |
| Total, other adverse events | Fingolimod 0.5 mg | 355 | 425 |
| Total, other adverse events | Placebo | 323 | 418 |
| Total, serious adverse events | Fingolimod 1.25 mg | 51 | 429 |
| Total, serious adverse events | Fingolimod 0.5 mg | 43 | 425 |
| Total, serious adverse events | Placebo | 56 | 418 |
Source ClinicalTrials.gov
Papers9
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.
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/NCT00289978
GET https://conductscience.org/api/trials/v1/NCT00289978/events?page=2