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Treatment Interruption of Natalizumab (RESTORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071083
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : January 30, 2013
Last Update Posted : September 19, 2013
Elan Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: natalizumab Drug: interferon beta 1-a Drug: methylprednisolone Other: IV placebo Drug: glatiramer acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Treatment Interruption of Natalizumab
Study Start Date : March 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071083

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United States, Alabama
Research Site
Cullman, Alabama, United States, 35058
United States, California
Research Site
San Francisco, California, United States, 94117
United States, Colorado
Research Site
Fort Collins, Colorado, United States
United States, Florida
Research Site
Pompano Beach, Florida, United States, 33060
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30309
Research Site
Atlanta, Georgia, United States, 30327
United States, Illinois
Research Site
Chicago, Illinois, United States, 60612
Research Site
Lake Barrington, Illinois, United States, 60010
United States, Iowa
Research Site
Des Moines, Iowa, United States, 50314
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 2135
Research Site
Boston, Massachusetts, United States, 2215
United States, New York
Research Site
Buffalo, New York, United States, 14203
Research Site
Latham, New York, United States, 12110
Research Site
Patchogue, New York, United States, 11772
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
Research Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
Research Site
Uniontown, Ohio, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84103
United States, Washington
Research Site
Seattle, Washington, United States, 98111
Research Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Research Site
Munchen, Bayern, Germany, 81675
Research Site
Hennigsdorf, Brandenburg, Germany, 16761
Research Site
Marburg, Hessen, Germany, 35039
Research Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Research Site
Dresden, Sachsen, Germany, 1307
Research Site
Hamburg, Germany, 20246
Research Site
L´Hospitalet de Llobregat, Barcelona, Spain, 8907
Research Site
Málaga, Malaga, Spain, 29010
Research Site
El Palmar, Murcia, Spain, 30120
Research Site
Barcelona, Spain, 8035
Research Site
Valencia, Spain, 46009
Research Site
Valencia, Spain, 46010
Sponsors and Collaborators
Elan Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biogen Identifier: NCT01071083    
Other Study ID Numbers: 101MS205
First Posted: February 19, 2010    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: September 19, 2013
Last Verified: November 2012
Keywords provided by Biogen:
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Glatiramer Acetate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Immunologic Factors