Trial record 1 of 1 for:    Randomized Treatment Interruption of Natalizumab
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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

February 17, 2010
September 12, 2013
March 2010
November 2011   (final data collection date for primary outcome measure)
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
Markers of immune function and disease activity during natalizumab treatment interruption and after natalizumab treatment is resumed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01071083 on ClinicalTrials.gov Archive Site
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.
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Treatment Interruption of Natalizumab
Randomized Treatment Interruption of Natalizumab

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
  • Drug: natalizumab
    300 mg intravenous every 4 weeks
  • Drug: interferon beta 1-a
    30 ug intramuscular once per week
  • Drug: methylprednisolone
    1000 mg intravenous every 4 weeks
  • Other: IV placebo
    placebo intravenous every 4 weeks
  • Drug: glatiramer acetate
    20 mg subcutaneous once daily
  • Active Comparator: natalizumab
    Intervention: Drug: natalizumab
  • Placebo Comparator: IV placebo
    Intervention: Other: IV placebo
  • Active Comparator: interferon β-1a, glatiramer acetate, or methylprednisolone
    Interventions:
    • Drug: interferon beta 1-a
    • Drug: methylprednisolone
    • Drug: glatiramer acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Spain
 
NCT01071083
101MS205
Not Provided
Biogen Idec
Biogen Idec
Elan Pharmaceuticals
Not Provided
Biogen Idec
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP