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Treatment Interruption of Natalizumab (RESTORE)

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ClinicalTrials.gov Identifier: NCT01071083
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : January 30, 2013
Last Update Posted : September 19, 2013
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01071083


  Show 33 Study Locations
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01071083     History of Changes
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:
MS

Additional relevant MeSH terms:
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
Interferons
Methylprednisolone Hemisuccinate
Prednisolone
Interferon-beta
Interferon beta-1a
Prednisolone acetate
Methylprednisolone acetate
 Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Natalizumab
Glatiramer Acetate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids