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MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV

NCT01970410 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-01-30

Study results available
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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).

Conditions

Interventions

DRUG

teriflunomide

14 mg oral teriflunomide daily

Sponsors & Collaborators

  • Multiple Sclerosis Center of Northeastern New York

    collaborator OTHER

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Keith R Edwards, MD · Multiple Sclerosis Center of Northeastern New York

  • Stanley Cohan, MD, Ph. D · Providence Multiple Sclerosis Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2021-04-30
Completion
2022-02-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970410 on ClinicalTrials.gov