Treatment Interruption of Natalizumab

Relapsing Remitting Multiple Sclerosis Clinical Trial

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Official title:

Randomized Treatment Interruption of Natalizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071083
• Other study ID #: 101MS205
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2010
• Last updated: September 12, 2013
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis

Intervention

Drug:
• natalizumab
300 mg intravenous every 4 weeks
• interferon beta 1-a
30 ug intramuscular once per week
• methylprednisolone
1000 mg intravenous every 4 weeks

Other:
• IV placebo
placebo intravenous every 4 weeks

Drug:
• glatiramer acetate
20 mg subcutaneous once daily

Locations

Country	Name	City	State
Germany	Research Site	Bochum	Nordrhein-Westfalen
Germany	Research Site	Dresden	Sachsen
Germany	Research Site	Freiburg	Baden-Wuerttemberg
Germany	Research Site	Hamburg
Germany	Research Site	Hennigsdorf	Brandenburg
Germany	Research Site	Marburg	Hessen
Germany	Research Site	Munchen	Bayern
Spain	Research Site	Barcelona
Spain	Research Site	El Palmar	Murcia
Spain	Research Site	L´Hospitalet de Llobregat	Barcelona
Spain	Research Site	Málaga	Malaga
Spain	Research Site	Valencia
Spain	Research Site	Valencia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buffalo	New York
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cullman	Alabama
United States	Research Site	Des Moines	Iowa
United States	Research Site	Fort Collins	Colorado
United States	Research Site	Lake Barrington	Illinois
United States	Research Site	Latham	New York
United States	Research Site	Patchogue	New York
United States	Research Site	Pompano Beach	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Francisco	California
United States	Research Site	Seattle	Washington
United States	Research Site	Uniontown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	28 Weeks	No
Secondary	Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.	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.	28 Weeks	No