Status:
COMPLETED
A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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-be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00441103
Start Date
December 1 2006
End Date
February 1 2009
Last Update
July 9 2014
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