Trial · NCT01201356
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
NCT01201356, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis. Trials, record NCT01201356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01201356
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
- NCT number
- NCT01201356
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,125 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Interventions
- Fingolimod
- First posted
- 2010-09-14
- Last updated
- 2021-04-21
- Other registries' IDs
- eudract:2010-020515-37
- Results first posted
- 2019-11-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death | Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years | Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed. |
| Secondary | Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed. |
| Secondary | Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5°C) or infection. In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed. |
| Secondary | Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod | Month 0 (Core Baseline) to End of Study (an average of Month 156) | Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed. |
| Secondary | Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume | Month 3 to End of Study (Study Completion Visit) | Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit. |
| Secondary | Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume | Month 3 to End of Study (Study Completion Visit) | T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit. |
| Secondary | Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod | Month 3 to Month 156 | Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement. |
| Secondary | Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod | Month 3 to Month 156 | The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = \[(SIENA/100+1) \^ (365.25/#days)-1\]\*100 where SIENA=(Vk/V0-1)\*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed. |
| Secondary | Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod | Month 12 to Month 156 | Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of \>=1 and \<=5.5, and by 0.5 points for patients with an FDF baseline EDSS\>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed. |
| Secondary | Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score | Month 3 to Month 6 Follow-up | The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration. If baseline EDSS score is \<=5, improvement is indicated by an EDSS score change of \<= -1, stable is indicated by an EDSS score change of \> -1 and \<= 0.5, deterioration is indicated by an EDSS score change of \> 0.5; if baseline EDSS score is \> 5, improvement is indicated by an EDSS score change of \<= -0.5, stable is indicated by an EDSS score change of \> -0.5 and \<= 0, deterioration is indicated by an EDSS score change of \> 0. Only descriptive analysis performed. |
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 | Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death | Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Annual number of relapses per patient | NUMBER |
| SECONDARY | Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Participants | NUMBER |
| SECONDARY | Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod | Month 0 (Core Baseline) to End of Study (an average of Month 156) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Annual number of T2 lesions per patient | NUMBER |
| SECONDARY | Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume | Month 3 to End of Study (Study Completion Visit) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | mm^3 | MEAN |
| SECONDARY | Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume | Month 3 to End of Study (Study Completion Visit) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | mm^3 | MEAN |
| SECONDARY | Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod | Month 3 to Month 156 | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Percent change | MEAN |
| SECONDARY | Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod | Month 3 to Month 156 | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Ratio | MEAN |
| SECONDARY | Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod | Month 12 to Month 156 | Fingolimod full analysis set | Participants | NUMBER |
| SECONDARY | Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score | Month 3 to Month 6 Follow-up | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group352
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death | Fingolimod 0.5 mg/Day | Adverse Event (AEs) | 2125 | Participants | |
| Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death | Fingolimod 0.5 mg/Day | Serious Adverse Events (SAEs) | 515 | Participants | |
| Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death | Fingolimod 0.5 mg/Day | Deaths | 16 | Participants | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 6 | 0.325 | Annual number of relapses per patient | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 12 | 0.273 | Annual number of relapses per patient | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 24 | 0.237 | Annual number of relapses per patient | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 36 | 0.217 | Annual number of relapses per patient | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 48 | 0.208 | Annual number of relapses per patient | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 60 | 0.197 | Annual number of relapses per patient | |
| Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Fingolimod 0.5 mg/Day | Month 0 to Month 72 | 0.190 | Annual number of relapses per patient |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod 0.5 mg/Day | 4,125 | |
| Overall Study | Safety Set | Fingolimod 0.5 mg/Day | 4,083 | |
| Overall Study | Fingolimod Full Analysis Set | Fingolimod 0.5 mg/Day | 4,046 | |
| Overall Study | COMPLETED | Fingolimod 0.5 mg/Day | 3,481 | |
| Overall Study | NOT COMPLETED | Fingolimod 0.5 mg/Day | 644 |
Source ClinicalTrials.gov
Adverse events407
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 | Fingolimod 0.5 mg/Day | 219 | 4,083 | |
| other | Fatigue | General disorders | Fingolimod 0.5 mg/Day | 232 | 4,083 | |
| other | Bronchitis | Infections and infestations | Fingolimod 0.5 mg/Day | 214 | 4,083 | |
| other | Influenza | Infections and infestations | Fingolimod 0.5 mg/Day | 275 | 4,083 | |
| other | Nasopharyngitis | Infections and infestations | Fingolimod 0.5 mg/Day | 706 | 4,083 | |
| other | Upper respiratory tract infection | Infections and infestations | Fingolimod 0.5 mg/Day | 346 | 4,083 | |
| other | Urinary tract infection | Infections and infestations | Fingolimod 0.5 mg/Day | 335 | 4,083 | |
| other | Hypercholesterolaemia | Metabolism and nutrition disorders | Fingolimod 0.5 mg/Day | 212 | 4,083 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fingolimod 0.5 mg/Day | 208 | 4,083 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fingolimod 0.5 mg/Day | 279 | 4,083 |
1 to 10 of 407Source ClinicalTrials.gov
See all 407 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod 0.5 mg/Day | 16 | 4,083 |
| Total, other adverse events | Fingolimod 0.5 mg/Day | 2,125 | 4,083 |
| Total, serious adverse events | Fingolimod 0.5 mg/Day | 515 | 4,083 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31598139 | DERIVED |
Source PubMed
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/NCT01201356
GET https://conductscience.org/api/trials/v1/NCT01201356/results?page=2