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Treatment Interruption of Natalizumab

NCT01071083 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2013-09-19

Study results available
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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.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

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

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01071083 on ClinicalTrials.gov