Clinical trial NCT01071083: Treatment Interruption of Natalizumab
Official title: Randomized Treatment Interruption of Natalizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: MS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2010-02-19
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 28 Weeks
Secondary outcomes:
measure: Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Research Site
state: Alabama
city: San Francisco
country: United States
facility: Research Site
state: California
city: Fort Collins
country: United States
facility: Research Site
state: Colorado
city: Pompano Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lake Barrington
country: United States
facility: Research Site
state: Illinois
city: Des Moines
country: United States
facility: Research Site
state: Iowa
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Latham
country: United States
facility: Research Site
state: New York
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Uniontown
country: United States
facility: Research Site
state: Ohio
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Freiburg
country: Germany
facility: Research Site
state: Baden-Wuerttemberg
city: Munchen
country: Germany
facility: Research Site
state: Bayern
city: Hennigsdorf
country: Germany
facility: Research Site
state: Brandenburg
city: Marburg
country: Germany
facility: Research Site
state: Hessen
city: Bochum
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Hamburg
country: Germany
facility: Research Site
city: L´Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Málaga
country: Spain
facility: Research Site
state: Malaga
city: El Palmar
country: Spain
facility: Research Site
state: Murcia
city: Barcelona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
Study officials:
References:
citation: 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.