Phase 2 Completed N=175 Randomized Quadruple-blind Treatment

Treatment Interruption of Natalizumab

Multiple Sclerosis

Source: ClinicalTrials.gov NCT01071083 ↗

Enrolled (actual)

175

Serious AEs

—

Results posted

Jan 2013

Primary outcomePrimary: 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. — 4.7; 60.5; 28.6; 53.3 Percentage of subjects meeting criteria

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.

Outcome Measures

Outcome	Result	p-value
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.	4.7; 60.5; 28.6; 53.3; 54.8	—
SECONDARY Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.	0.0; 52.5; 8.3; 49.7; 46.1	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01071083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.