Status:
COMPLETED
Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Pfizer
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
Detailed Description
As has been seen with other recombinant protein molecules, the use of injectable recombinant proteins may result in the development of neutralising antibodies (NAbs). Antibodies are considered neutral...
Eligibility Criteria
Inclusion
- Participant has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in accordance with the McDonald criteria
- Participant is eligible for interferon therapy
- Participant is between 18 and 60 years old
- Participant has an Expanded Disability Status Scale (EDSS) \< 6.0.
- Participant is willing to follow study procedures
- Participant has given written informed consent
- Female participants must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
- Being post-menopausal or surgically sterile, or
- Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study.
- Confirmation that the participant is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy test is not required if the participant is post-menopausal or surgically sterile.
Exclusion
- Participant has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
- Participant had any prior interferon beta therapy (either beta-1b or beta-1a)
- Participant has an ongoing MS relapse.
- Participant received any other approved disease modifying therapy for MS (e.g. glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 1(SD1).
- Participant had prior use of cladribine or has previously received total lymphoid irradiation.
- Participant received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days of SD1.
- Participant received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1.
- Participant received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months prior to SD1.
- Participant requires chronic or monthly pulse corticosteroids during the study.
- Participant received any investigational drug or experimental procedure within 12 weeks of SD1.
- Participant has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase \> 2.5 times the upper limit of the normal values.
- Participant has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
- Participant suffers from current autoimmune disease.
- Participant suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol.
- Participant has a known allergy to IFN or the excipients.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00110396
Start Date
January 1 2005
End Date
April 1 2007
Last Update
July 15 2015
Active Locations (1)
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1
Local US Medical Information
Rockland, Massachusetts, United States, 02370