Phase 3 N=180 Randomized Double-blind Treatment

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

Multiple Sclerosis, Relapsing-Remitting

Bottom Line

View on ClinicalTrials.gov: NCT00441103 ↗

Enrolled (actual)

180

Serious AEs

3.9%

Results posted

Jul 2010

Primary outcome: Primary: Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16 — 0.9; 3.0 lesions — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rebif® New Formulation (IFN-beta-1a, RNF) (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16	0.9; 3.0	<0.001 sig
PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	100; 39; 72; 43; 4; 3	—
SECONDARY Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.	2.31; 0.65	<0.001 sig
SECONDARY Number of CU Active MRI Lesions	0.62; 1.27	—

Summary

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.

Eligibility Criteria

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
Other protocol defined exclusion criteria could apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00441103). 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.