Treatment Interruption of Natalizumab (RESTORE)

Biogen

Status and phase: Completed; Phase 2

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: glatiramer acetate; Drug: methylprednisolone; Other: IV placebo; Drug: interferon beta 1-a; Drug: natalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071083

101MS205

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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175 participants in 3 patient groups, including a placebo group

natalizumab

Active Comparator group

Treatment:

Drug: natalizumab

IV placebo

Placebo Comparator group

Treatment:

Other: IV placebo

interferon β-1a, glatiramer acetate, or methylprednisolone

Active Comparator group

Treatment:

Drug: interferon beta 1-a

Drug: methylprednisolone

Drug: glatiramer acetate