Treatment Interruption of Natalizumab

Phase 2

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: natalizumab; Other: IV placebo; Drug: interferon beta 1-a; Drug: methylprednisolone; Drug: glatiramer acetate

• Registration Number: NCT01071083
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-19
• Study Start: 2010-03
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2012-10-25
• Status Verified: 2012-11
• Results First Submitted QC: 2012-12-20
• Results First Posted: 2013-01-30
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
natalizumab	natalizumab	-
IV placebo	IV placebo	-
interferon β-1a, glatiramer acetate, or methylprednisolone	interferon beta 1-a	-
interferon β-1a, glatiramer acetate, or methylprednisolone	methylprednisolone	-
interferon β-1a, glatiramer acetate, or methylprednisolone	glatiramer acetate	-

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.	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.

Trial Locations

Locations (1)

Research Site; 🇪🇸 Valencia, Spain