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Treatment Interruption of Natalizumab (RESTORE)

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
natalizumab
interferon beta 1-a
methylprednisolone
IV placebo
glatiramer acetate
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring MS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

natalizumab

IV placebo

interferon β-1a, glatiramer acetate, or methylprednisolone

Arm Description

Outcomes

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.
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.
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.

Full Information

First Posted
February 17, 2010
Last Updated
September 12, 2013
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01071083
Brief Title
Treatment Interruption of Natalizumab
Acronym
RESTORE
Official Title
Randomized Treatment Interruption of Natalizumab
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
Elan Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
natalizumab
Arm Type
Active Comparator
Arm Title
IV placebo
Arm Type
Placebo Comparator
Arm Title
interferon β-1a, glatiramer acetate, or methylprednisolone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
natalizumab
Intervention Description
300 mg intravenous every 4 weeks
Intervention Type
Drug
Intervention Name(s)
interferon beta 1-a
Intervention Description
30 ug intramuscular once per week
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
1000 mg intravenous every 4 weeks
Intervention Type
Other
Intervention Name(s)
IV placebo
Intervention Description
placebo intravenous every 4 weeks
Intervention Type
Drug
Intervention Name(s)
glatiramer acetate
Intervention Description
20 mg subcutaneous once daily
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
28 Weeks
Secondary Outcome Measure Information:
Title
Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
Description
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.
Time Frame
28 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Research Site
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Research Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2135
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2215
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Research Site
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Research Site
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Uniontown
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Research Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Hennigsdorf
State/Province
Brandenburg
ZIP/Postal Code
16761
Country
Germany
Facility Name
Research Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
Facility Name
Research Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Research Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1307
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
L´Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Research Site
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26049148
Citation
Nakamura 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.
Results Reference
derived

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Treatment Interruption of Natalizumab

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