CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
teriflunomidedrug
Likely dose
teriflunomide 14 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01970410
NCT01970410Phase 4Completed

MAIN STUDY: Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? SUB-STUDY: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide

Providence Health & Services·interventional·Posted Oct 28, 2013·Updated Jan 30, 2023

In Brief

A Phase 4 clinical trial evaluating teriflunomide for Multiple Sclerosis. Completed, enrolled 55 participants across 3 sites.

Detailed Summary

MAIN STUDY: The purpose of this study is to determine if teriflunomide will be safe and effective to prevent relapses in patients with relapsing types of MS when switching from natalizumab to teriflunomide in patients at risk for PML. This is a two center interventional study of patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab positive, and who had been free of clinical relapses during prior 12 months of natalizumab therapy who will be switching to teriflunomide. SUB-STUDY: To study the number of patients experiencing a reduction in the anti-JCV antibody Index value in patients who had received at least one dose of teriflunomide during participation in the SWITCH protocol (main study).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 28, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 30, 2021
Study CompletionFeb 14, 2022
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 12.7 years ago

Interventions

teriflunomidedrug

14 mg oral teriflunomide daily