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 (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Treatment Interruption of Natalizumab

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen:

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 ]
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 ]
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 (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

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

Elan Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Biogen
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

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

ClinicalTrials.gov processed this record on July 21, 2017

Treatment Interruption of Natalizumab (RESTORE)