Treatment Interruption of Natalizumab (RESTORE)
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| ClinicalTrials.gov Identifier: NCT01071083 |
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Recruitment Status :
Completed
First Posted : February 19, 2010
Results First Posted : January 30, 2013
Last Update Posted : September 19, 2013
|
Sponsor:
Biogen
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
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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 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
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Natalizumab
| 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 |
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.
Information from the National Library of Medicine
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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
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
Locations
| United States, Alabama | |
| Research Site | |
| Cullman, Alabama, United States, 35058 | |
| United States, California | |
| Research Site | |
| San Francisco, California, United States, 94117 | |
| United States, Colorado | |
| Research Site | |
| Fort Collins, Colorado, United States | |
| United States, Florida | |
| Research Site | |
| Pompano Beach, Florida, United States, 33060 | |
| United States, Georgia | |
| Research Site | |
| Atlanta, Georgia, United States, 30309 | |
| Research Site | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States, 60612 | |
| Research Site | |
| Lake Barrington, Illinois, United States, 60010 | |
| United States, Iowa | |
| Research Site | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States, 2135 | |
| Research Site | |
| Boston, Massachusetts, United States, 2215 | |
| United States, New York | |
| Research Site | |
| Buffalo, New York, United States, 14203 | |
| Research Site | |
| Latham, New York, United States, 12110 | |
| Research Site | |
| Patchogue, New York, United States, 11772 | |
| United States, North Carolina | |
| Research Site | |
| Charlotte, North Carolina, United States, 28207 | |
| Research Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Research Site | |
| Cleveland, Ohio, United States, 44195 | |
| Research Site | |
| Uniontown, Ohio, United States | |
| United States, Utah | |
| Research Site | |
| Salt Lake City, Utah, United States, 84103 | |
| United States, Washington | |
| Research Site | |
| Seattle, Washington, United States, 98111 | |
| Germany | |
| Research Site | |
| Freiburg, Baden-Wuerttemberg, Germany, 79106 | |
| Research Site | |
| Munchen, Bayern, Germany, 81675 | |
| Research Site | |
| Hennigsdorf, Brandenburg, Germany, 16761 | |
| Research Site | |
| Marburg, Hessen, Germany, 35039 | |
| Research Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44791 | |
| Research Site | |
| Dresden, Sachsen, Germany, 1307 | |
| Research Site | |
| Hamburg, Germany, 20246 | |
| Spain | |
| Research Site | |
| L´Hospitalet de Llobregat, Barcelona, Spain, 8907 | |
| Research Site | |
| Málaga, Malaga, Spain, 29010 | |
| Research Site | |
| El Palmar, Murcia, Spain, 30120 | |
| Research Site | |
| Barcelona, Spain, 8035 | |
| Research Site | |
| Valencia, Spain, 46009 | |
| Research Site | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT01071083 |
| 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 Interferon-beta Interferon beta-1a Methylprednisolone Glatiramer Acetate Natalizumab (T,G)-A-L |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Immunologic Factors |