Treatment Interruption of Natalizumab
RESTORE
Randomized Treatment Interruption of Natalizumab
1 other identifier
interventional
175
3 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
January 30, 2013
CompletedSeptember 19, 2013
November 1, 2012
1.7 years
February 17, 2010
October 25, 2012
September 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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 Outcomes (1)
Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
28 Weeks
Study Arms (3)
natalizumab
ACTIVE COMPARATORIV placebo
PLACEBO COMPARATORinterferon β-1a, glatiramer acetate, or methylprednisolone
ACTIVE COMPARATORInterventions
30 ug intramuscular once per week
1000 mg intravenous every 4 weeks
20 mg subcutaneous once daily
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (33)
Research Site
Cullman, Alabama, 35058, United States
Research Site
San Francisco, California, 94117, United States
Research Site
Fort Collins, Colorado, United States
Research Site
Pompano Beach, Florida, 33060, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Atlanta, Georgia, 30327, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Lake Barrington, Illinois, 60010, United States
Research Site
Des Moines, Iowa, 50314, United States
Research Site
Boston, Massachusetts, 2135, United States
Research Site
Boston, Massachusetts, 2215, United States
Research Site
Buffalo, New York, 14203, United States
Research Site
Latham, New York, 12110, United States
Research Site
Patchogue, New York, 11772, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Uniontown, Ohio, United States
Research Site
Salt Lake City, Utah, 84103, United States
Research Site
Seattle, Washington, 98111, United States
Research Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Research Site
München, Bavaria, 81675, Germany
Research Site
Hennigsdorf, Brandenburg, 16761, Germany
Research Site
Hamburg, Hamburg, 20246, Germany
Research Site
Marburg, Hesse, 35039, Germany
Research Site
Bochum, North Rhine-Westphalia, 44791, Germany
Research Site
Dresden, Saxony, 1307, Germany
Research Site
Barcelona, Barcelona, 8035, Spain
Research Site
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Research Site
Málaga, Malaga, 29010, Spain
Research Site
El Palmar, Murcia, 30120, Spain
Research Site
Valencia, Valencia, 46009, Spain
Research Site
Valencia, Valencia, 46010, Spain
Related Publications (2)
Fox RJ, Cree BAC, de Seze J, Gold R, Hartung HP, Jeffery D, Kappos L, Montalban X, Weinstock-Guttman B, Singh CM, Altincatal A, Belviso N, Avila RL, Ho PR, Su R, Engle R, Sangurdekar D, de Moor C, Fisher E, Kieseier BC, Rudick RA. Temporal Relationship Between Serum Neurofilament Light Chain and Radiologic Disease Activity in Patients With Multiple Sclerosis. Neurology. 2024 May 14;102(9):e209357. doi: 10.1212/WNL.0000000000209357. Epub 2024 Apr 22.
PMID: 38648580DERIVEDNakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
PMID: 26049148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Idec Medical Director
- Organization
- Biogen Idec Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 19, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
September 19, 2013
Results First Posted
January 30, 2013
Record last verified: 2012-11