Trial · NCT02342704
Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
NCT02342704, Phase 4, Terminated, Biogen; results first posted 2017-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants. Trials, record NCT02342704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02342704
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
- NCT number
- NCT02342704
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 111 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- natalizumab, fingolimod
- First posted
- 2015-01-21
- Last updated
- 2017-06-09
- Other registries' IDs
- eudract:2013-004622-29
- Results first posted
- 2017-06-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions | Up to Week 52 | |
| Secondary | Cumulative Number of New T1-Gd+ Lesions | Baseline, Week 4, Week 12, Week 24 | |
| Secondary | Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Baseline, Week 24 | As assessed by magnetic resonance imaging (MRI). |
| Secondary | Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52 | Baseline, Week 52 | As assessed by MRI. |
| Secondary | Cumulative Number of New or Enlarging T2 Lesions | Baseline, Week 24 | |
| Secondary | Proportion of Participants With No Evidence of Disease Activity (NEDA) | Up to Week 52 | NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions. |
| Secondary | Time to First Relapse | Up to Week 52 | A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. |
| Secondary | Cumulative Risk of Relapse | Up to Week 52 | A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. |
| Secondary | Time to Complete Recovery From First Relapse | Up to Week 52 | 12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks. |
| Secondary | Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24 | Baseline, Week 24 | The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. |
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 | Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions | Up to Week 52 | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | ||
| SECONDARY | Cumulative Number of New T1-Gd+ Lesions | Baseline, Week 4, Week 12, Week 24 | Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment. | lesions | MEAN |
| SECONDARY | Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Baseline, Week 24 | Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment. | percentage change | MEAN |
| SECONDARY | Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52 | Baseline, Week 52 | Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment. | percentage change | MEAN |
| SECONDARY | Cumulative Number of New or Enlarging T2 Lesions | Baseline, Week 24 | Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment. | lesions | MEAN |
| SECONDARY | Proportion of Participants With No Evidence of Disease Activity (NEDA) | Up to Week 52 | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | ||
| SECONDARY | Time to First Relapse | Up to Week 52 | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | ||
| SECONDARY | Cumulative Risk of Relapse | Up to Week 52 | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | ||
| SECONDARY | Time to Complete Recovery From First Relapse | Up to Week 52 | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | ||
| SECONDARY | Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24 | Baseline, Week 24 | Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values. | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Number of New T1-Gd+ Lesions | Natalizumab | From Baseline to Week 4 | 0.62 | Standard Deviation 1.512 | lesions |
| Cumulative Number of New T1-Gd+ Lesions | Fingolimod | From Baseline to Week 4 | 1.69 | Standard Deviation 4.122 | lesions |
| Cumulative Number of New T1-Gd+ Lesions | Natalizumab | From Baseline to Week 12 | 0.68 | Standard Deviation 1.695 | lesions |
| Cumulative Number of New T1-Gd+ Lesions | Fingolimod | From Baseline to Week 12 | 2.27 | Standard Deviation 4.499 | lesions |
| Cumulative Number of New T1-Gd+ Lesions | Natalizumab | From Baseline to Week 24 | 0.72 | Standard Deviation 1.69 | lesions |
| Cumulative Number of New T1-Gd+ Lesions | Fingolimod | From Baseline to Week 24 | 2.6 | Standard Deviation 4.745 | lesions |
| Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Natalizumab | T1 Lesion Volume Change | 0.5 | Standard Deviation 31.235 | percentage change |
| Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Fingolimod | T1 Lesion Volume Change | 1.81 | Standard Deviation 19.703 | percentage change |
| Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Natalizumab | T2 Lesion Volume Change | 0.08 | Standard Deviation 4.399 | percentage change |
| Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Fingolimod | T2 Lesion Volume Change | 3.32 | Standard Deviation 5.036 | percentage change |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Natalizumab | 54 | |
| Overall Study | STARTED | Fingolimod | 54 | |
| Overall Study | COMPLETED | Natalizumab | 1 | |
| Overall Study | COMPLETED | Fingolimod | 3 | |
| Overall Study | NOT COMPLETED | Natalizumab | 53 | |
| Overall Study | NOT COMPLETED | Fingolimod | 51 |
Source ClinicalTrials.gov
Adverse events26
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 | Headache | Nervous system disorders | Natalizumab | 6 | 54 | |
| other | Headache | Nervous system disorders | Fingolimod | 4 | 54 | |
| other | Multiple sclerosis relapse | Nervous system disorders | Natalizumab | 1 | 54 | |
| other | Multiple sclerosis relapse | Nervous system disorders | Fingolimod | 8 | 54 | |
| other | Hypoaesthesia | Nervous system disorders | Natalizumab | 0 | 54 | |
| other | Hypoaesthesia | Nervous system disorders | Fingolimod | 3 | 54 | |
| other | Migraine | Nervous system disorders | Natalizumab | 0 | 54 | |
| other | Migraine | Nervous system disorders | Fingolimod | 3 | 54 | |
| other | Upper respiratory tract infection | Infections and infestations | Natalizumab | 1 | 54 | |
| other | Upper respiratory tract infection | Infections and infestations | Fingolimod | 5 | 54 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Natalizumab | ||
| Total, all-cause mortality | Fingolimod | ||
| Total, other adverse events | Natalizumab | 14 | 54 |
| Total, other adverse events | Fingolimod | 23 | 54 |
| Total, serious adverse events | Natalizumab | 0 | 54 |
| Total, serious adverse events | Fingolimod | 2 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33082194 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Natalizumab vs Fingolimod: serious adverse events |
Source Trial comparisons
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/NCT02342704
GET https://conductscience.org/api/trials/v1/NCT02342704/events?page=2