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Alternative Treatment Paradigm for Natalizumab Trial

NCT01710228 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-12-29

No results posted yet for this study

Summary

This study is being done to determine the difference between natalizumab therapy followed by two different withdrawal strategies using Glatiramer Acetate (GA) treatment paradigms in preventing clinical relapses and other markers of disease activity in patients diagnosed with Multiple Sclerosis (MS).

We hypothesize that GA plus corticosteroids versus GA alone will prevent or reduce the re-occurrence of MS disease activity after discontinuation of natalizumab over a 12 month period. We further hypothesize that natalizumab therapy followed by GA treatment allows the reconstitution of the peripheral and CNS immune homeostasis.

Primary objective:

The primary endpoint will be the annualized relapse rate over the post randomization months as well as estimates of change over the natalizumab therapy period over the entire 12 months.

Secondary objectives:

To determine if and how long it takes for restoration of immune homeostasis under GA therapy following discontinuation of natalizumab.

Conditions

  • Multiple Sclerosis (MS)

Interventions

DRUG

methylprednisolone

192 MG FOR 5 CONSECUTIVE DAYS EVERY 4 WEEKS FOR 10 MONTHS

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Olaf Stuve, MD PhD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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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 NCT01710228 on ClinicalTrials.gov