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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Rebif® New Formulation (IFN-beta-1a, RNF) (Drug); Placebo (Drug); Rebif® New Formulation (IFN-beta-1a, RNF) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Bettina Stubinski, MD, Study Director, Affiliation: Merck Serono SA - Geneva, an affiliate of Merck KGaA Darmstadt, Germany

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.

Clinical Details

Official title: A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcome:

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.

Number of CU Active MRI Lesions

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Full FDA approved prescribing information can be found here

Starting date: December 2006
Last updated: June 6, 2014

Page last updated: August 20, 2015

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