A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-02-28

Brief Summary

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General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rebif® New Formulation (IFN-beta-1a, RNF)

Group Type EXPERIMENTAL

Rebif® New Formulation (IFN-beta-1a, RNF)

Intervention Type DRUG

RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.

Placebo/RNF

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo will be administered subcutaneously three times a week for 16 weeks.

Rebif® New Formulation (IFN-beta-1a, RNF)

Intervention Type DRUG

RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.

Interventions

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Rebif® New Formulation (IFN-beta-1a, RNF)

RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.

Intervention Type DRUG

Placebo

Matching placebo will be administered subcutaneously three times a week for 16 weeks.

Intervention Type DRUG

Rebif® New Formulation (IFN-beta-1a, RNF)

RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.

Intervention Type DRUG

Other Intervention Names

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IFN-beta-1a IFN-beta-1a

Eligibility Criteria

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Inclusion Criteria

* Males and females between 18 and 60 years of age
* Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study
* Have Relapsing Remitting Multiple Sclerosis (RRMS) according to the revised McDonald criteria 2005
* Have brain and/or spinal MRI with findings typical of Multiple Sclerosis (MS)
* Have disease duration for more than 12 months
* Have disease activity characterized by at least one clinical event and one or more Gadolinium-enhancing MRI lesions within the 6 months prior to randomization
* Have score of \<=5.5 on the Expanded Disability Status Scale (EDSS)
* Be willing and able to comply with the protocol for the duration of the study
* Have given written informed consent prior to any study-related procedure not part of the normal medical practice

Exclusion Criteria

* Have any disease other than MS that could better explain his/her signs and symptoms
* Have complete transverse myelitis or bilateral optic neuritis
* Have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone \[ACTH\]), or total lymphoid irradiation
* Have received within 3 months prior to baseline any approved disease-modifying therapy for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure
* Have received within 30 days prior to baseline oral or systemic corticosteroids or ACTH

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No