Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
NCT00110396
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis | |||
Official Title ICMJE | A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis | |||
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 neutralising by their ability to inhibit the biological effect of interferon in a bioassay system. EMD Serono has actively pursued improvements in the formulation of interferon (IFN) beta-1a to reduce aggregate levels and to develop a formulation that is HSA-free. Reducing aggregates should reduce antigenicity of the product while removal of HSA may have an unpredictable effect on antigenicity. EMD Serono will conduct a study to assess the immunogenicity and safety of the new HSA-free formulation, manufactured using IFN-ß-1a drug substance produced by a new clone from the FBS-free process. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Multiple Sclerosis | |||
Intervention ICMJE | Biological: Interferon-beta-1a FBS-free/HSA-free
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks. | |||
Study Arms ICMJE | Experimental: Rebif New Formulation Cohort
Intervention: Biological: Interferon-beta-1a FBS-free/HSA-free | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 260 | |||
Original Enrollment ICMJE | 230 | |||
Actual Study Completion Date ICMJE | April 2007 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00110396 | |||
Other Study ID Numbers ICMJE | 25632 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Susan Fischer, EMD Serono Inc | |||
Study Sponsor ICMJE | EMD Serono | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | EMD Serono | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |