Trial · NCT00340834
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
NCT00340834, Phase 3, Completed, Novartis; results first posted 2011-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase. Trials, record NCT00340834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00340834
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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 With Optional Extension Phase
- NCT number
- NCT00340834
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,292 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Multiple Sclerosis
- Interventions
- Fingolimod 1.25 mg, Fingolimod 0.5 mg, Interferon β-1a 30 µg
- First posted
- 2006-06-21
- Last updated
- 2017-09-21
- Results first posted
- 2011-05-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | Baseline to Month 12 | 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score. |
| Secondary | Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | Baseline to Month 12 | The number of new or newly enlarged T2 lesions 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. |
| Secondary | Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | Baseline to Month 12 | The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: 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. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. |
| Secondary | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 0 to end of study (up to approximately 4.5 years) | 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score. |
| Secondary | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 12 to end of study (up to approximately 3.5 years) | The number of new or newly enlarged T2 lesions 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. |
| Secondary | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Baseline to end of study (up to approximately 4.5 years) | The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: 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. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes6
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) in the Core Phase of the Study | Baseline to Month 12 | Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication. | Estimate relapses per year | NUMBER |
| SECONDARY | Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | Baseline to Month 12 | Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication. | T2 lesions | MEAN |
| SECONDARY | Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | Baseline to Month 12 | Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 0 to end of study (up to approximately 4.5 years) | Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication. | Estimated relapses per year | NUMBER |
| SECONDARY | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 12 to end of study (up to approximately 3.5 years) | Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication. | T2 lesions | MEAN |
| SECONDARY | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Baseline to end of study (up to approximately 4.5 years) | Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
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) in the Core Phase of the Study | Fingolimod 1.25 mg | 0.203 | 95% Confidence Interval 0.157 to 0.264 | Estimate relapses per year | |
| Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | Fingolimod 0.5 mg | 0.161 | 95% Confidence Interval 0.122 to 0.212 | Estimate relapses per year | |
| Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | 0.331 | 95% Confidence Interval 0.262 to 0.417 | Estimate relapses per year | |
| Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | Fingolimod 1.25 mg | 1.6 | Standard Deviation 3.23 | T2 lesions | |
| Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | Fingolimod 0.5 mg | 1.6 | Standard Deviation 3.16 | T2 lesions | |
| Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | 2.6 | Standard Deviation 5.50 | T2 lesions | |
| Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | Fingolimod 1.25 mg | 93.3 | 95% Confidence Interval 90.92 to 95.77 | Percentage of participants | |
| Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | Fingolimod 0.5 mg | 94.1 | 95% Confidence Interval 91.82 to 96.33 | Percentage of participants | |
| Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | 92.1 | 95% Confidence Interval 89.45 to 94.66 | Percentage of participants | |
| Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Fingolimod 1.25 mg | Month 12 to Month 24, n=330, 356, 341 | 0.156 | 95% Confidence Interval 0.114 to 0.214 | Estimated relapses per year |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase of Study | STARTED | Fingolimod 1.25 mg | 426 | |
| Core Phase of Study | STARTED | Fingolimod 0.5 mg | 431 | |
| Core Phase of Study | STARTED | Interferon β-1a 30 µg | 435 | |
| Core Phase of Study | STARTED | Interferon β-1a/Fingolimod 1.25 mg | 0 | |
| Core Phase of Study | STARTED | Interferon β-1a/Fingolimod 0.5 mg | 0 | |
| Core Phase of Study | COMPLETED | Fingolimod 1.25 mg | 369 | |
| Core Phase of Study | COMPLETED | Fingolimod 0.5 mg | 398 | |
| Core Phase of Study | COMPLETED | Interferon β-1a 30 µg | 386 | |
| Core Phase of Study | COMPLETED | Interferon β-1a/Fingolimod 1.25 mg | 0 | |
| Core Phase of Study | COMPLETED | Interferon β-1a/Fingolimod 0.5 mg | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,270
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 | Lymphopenia | Blood and lymphatic system disorders | COR FTY720 1.25 mg | 3 | 420 | |
| other | Lymphopenia | Blood and lymphatic system disorders | COR FTY720 0.5 mg | 1 | 429 | |
| other | Lymphopenia | Blood and lymphatic system disorders | COR Interferon Beta-1a | 0 | 431 | |
| other | Lymphopenia | Blood and lymphatic system disorders | EXT FTY720 1.25 mg | 108 | 504 | |
| other | Lymphopenia | Blood and lymphatic system disorders | EXT FTY720 0.5 mg | 77 | 523 | |
| other | Diarrhoea | Gastrointestinal disorders | COR FTY720 1.25 mg | 35 | 420 | |
| other | Diarrhoea | Gastrointestinal disorders | COR FTY720 0.5 mg | 32 | 429 | |
| other | Diarrhoea | Gastrointestinal disorders | COR Interferon Beta-1a | 21 | 431 | |
| other | Diarrhoea | Gastrointestinal disorders | EXT FTY720 1.25 mg | 48 | 504 | |
| other | Diarrhoea | Gastrointestinal disorders | EXT FTY720 0.5 mg | 50 | 523 |
1 to 10 of 1,270Source ClinicalTrials.gov
See all 1,270 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COR FTY720 1.25 mg | ||
| Total, all-cause mortality | COR FTY720 0.5 mg | ||
| Total, all-cause mortality | COR Interferon Beta-1a | ||
| Total, all-cause mortality | EXT FTY720 1.25 mg | ||
| Total, all-cause mortality | EXT FTY720 0.5 mg | ||
| Total, other adverse events | COR FTY720 1.25 mg | 310 | 420 |
| Total, other adverse events | COR FTY720 0.5 mg | 302 | 429 |
| Total, other adverse events | COR Interferon Beta-1a | 359 | 431 |
| Total, other adverse events | EXT FTY720 1.25 mg | 446 | 504 |
| Total, other adverse events | EXT FTY720 0.5 mg | 439 | 523 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers7
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.
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