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NCT01895335 · ClinicalTrials.gov registry record · Phase 4
Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
A Phase 4 study of Multiple Sclerosis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,001
- Enrollment target
- 20
- Study locations
NCT01895335: Completed Phase 4 study of Multiple Sclerosis, sponsored by Sanofi.
NCT01895335 is a Phase 4 study of Multiple Sclerosis that has completed, run by Sanofi. The registered enrollment target is 1,001 participants, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01895335, a Phase 4 study of Multiple Sclerosis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,001 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant. To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.
Primary Outcome
TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. H
Conditions Studied
Interventions
- DRUG Teriflunomide
Study Locations (20)
California
- Investigational Site Number 840018 - Fullerton
- Investigational Site Number 840037 - Fullerton
- Investigational Site Number 840108 - Long Beach
- Investigational Site Number 840014 - Newport Beach
- Investigational Site Number 840019 - Oceanside
Colorado
- Investigational Site Number 840097 - Boulder
- Investigational Site Number 840040 - Colorado Springs
- Investigational Site Number 840046 - Denver
- Investigational Site Number 840016 - Englewood
- Investigational Site Number 840094 - Fort Collins
Arizona
- Investigational Site Number 840087 - Phoenix
- Investigational Site Number 840114 - Phoenix
- Investigational Site Number 840080 - Scottsdale
- Investigational Site Number 840032 - Tucson
Florida
- Investigational Site Number 840024 - Bradenton
- Investigational Site Number 840089 - Clearwater
- Investigational Site Number 840055 - Coconut Creek
Alabama
- Investigational Site Number 840077 - Birmingham
- Investigational Site Number 840007 - Cullman
Arkansas
- Investigational Site Number 840021 - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,001 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-11 |
| Phase | Phase 4 |
What the finished NCT01895335 record still lists
NCT01895335 is an interventional study that assigns participants to a tested intervention. Its 1,001 participants enrollment target places it among the larger protocols in the corpus, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (72% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Teriflunomide is the first listed.
NCT01895335 names 20 study sites across 6 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT01895335 about?
NCT01895335 is a clinical study titled "Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients". Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide ...
What is the current status of trial NCT01895335?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,001 participants. The study started on 2013-06. Estimated completion is 2015-11.
What conditions does trial NCT01895335 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT01895335?
The interventions under investigation include: Teriflunomide (DRUG).
Who is sponsoring clinical trial NCT01895335?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01895335 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01895335's enrollment target sits among peer trials
1,001 25th of 315 higher than 291 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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