Treatment Interruption of Natalizumab (RESTORE)

September 12, 2013 updated by: Biogen

Randomized Treatment Interruption of Natalizumab

This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.

The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks:

  • when MS symptoms return, and
  • if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.

This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Research Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Research Site
    • Bayern
      • Munchen, Bayern, Germany, 81675
        • Research Site
    • Brandenburg
      • Hennigsdorf, Brandenburg, Germany, 16761
        • Research Site
    • Hessen
      • Marburg, Hessen, Germany, 35039
        • Research Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Research Site
    • Sachsen
      • Dresden, Sachsen, Germany, 1307
        • Research Site
  • Spain
      • Barcelona, Spain, 8035
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
      • Valencia, Spain, 46009
        • Research Site
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Research Site
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Research Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Research Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • Research Site
    • California
      • San Francisco, California, United States, 94117
        • Research Site
    • Colorado
      • Fort Collins, Colorado, United States
        • Research Site
    • Florida
      • Pompano Beach, Florida, United States, 33060
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Atlanta, Georgia, United States, 30327
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Lake Barrington, Illinois, United States, 60010
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 2135
        • Research Site
      • Boston, Massachusetts, United States, 2215
        • Research Site
    • New York
      • Buffalo, New York, United States, 14203
        • Research Site
      • Latham, New York, United States, 12110
        • Research Site
      • Patchogue, New York, United States, 11772
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
      • Uniontown, Ohio, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98111
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major criteria include:

  • A diagnosis of a relapsing form of MS
  • Treatment with natalizumab according to locally approved prescribing information
  • Other protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: natalizumab
Drug: natalizumab
300 mg intravenous every 4 weeks
Placebo Comparator: IV placebo
Other: IV placebo
placebo intravenous every 4 weeks
Active Comparator: interferon β-1a, glatiramer acetate, or methylprednisolone
Drug: interferon beta 1-a
30 ug intramuscular once per week
Drug: methylprednisolone
1000 mg intravenous every 4 weeks
Drug: glatiramer acetate
20 mg subcutaneous once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.
Time Frame: 28 Weeks
Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5
28 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
Time Frame: 28 Weeks
MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.
28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101MS205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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