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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 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.

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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.

Conditions Studied

Multiple Sclerosis

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

FieldValue
Enrollment Target 1,001 participants
Start Date 2013-06
Est. Completion 2015-11
Phase Phase 4

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT01895335

The ClinicalTrials.gov registry entry for NCT01895335 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,001 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (72% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.