Treatment Interruption of Natalizumab (RESTORE)

This study has been completed.

Sponsor:

Collaborator:

Elan Pharmaceuticals

Information provided by (Responsible Party):

Biogen Idec

ClinicalTrials.gov Identifier:

NCT01071083

First received: February 17, 2010

Last updated: September 12, 2013

Last verified: November 2012

History of Changes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 33 Study Locations

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:	September 12, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:


MS

Additional relevant MeSH terms:


Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Copolymer 1 Methylprednisolone Methylprednisolone Hemisuccinate Methylprednisolone acetate Prednisolone Prednisolone acetate Prednisolone hemisuccinate	Prednisolone phosphate Adjuvants, Immunologic Anti-Inflammatory Agents Antiemetics Antineoplastic Agents Antineoplastic Agents, Hormonal Autonomic Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunologic Factors Immunosuppressive Agents Neuroprotective Agents

ClinicalTrials.gov processed this record on March 03, 2015

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