Treatment Interruption of Natalizumab - Full Text View

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Treatment Interruption of Natalizumab

Resource links provided by NLM:

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
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.

Enrollment:	175
Study Start Date:	March 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071083

Hide Study Locations

Locations

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, 30327
Research Site
Atlanta, Georgia, United States, 30309
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
Germany
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
Spain
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, 46010
Research Site
Valencia, Spain, 46009

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

More Information

No publications provided

Responsible Party:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT01071083 History of Changes
Other Study ID Numbers:	101MS205
Study First Received:	February 17, 2010
Results First Received:	October 25, 2012
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

MS

Additional relevant MeSH terms:

Multiple Sclerosis
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
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Copolymer 1
Methylprednisolone Hemisuccinate

Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics

ClinicalTrials.gov processed this record on May 19, 2013

Treatment Interruption of Natalizumab (RESTORE)