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Sponsors and Collaborators: |
EMD Serono Pfizer |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00110396 |
The primary objective of the study is to compare the antigenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: Interferon-beta-1a FBS-free/HSA-free |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (IFN-Beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis |
Enrollment: | 230 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | November 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Interferon-beta-1a FBS-free/HSA-free
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
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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. 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. 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.
The design of this study assumes that the Phase I tolerability and pharmacokinetic (PK) data of the selected formulation is similar to the currently approved HSA-containing formulation.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Local US Medical Information | |
Rockland, Massachusetts, United States, 02370 |
Study Director: | Bettina Stubinski, MD | Merck Serono International SA |
Responsible Party: | EMD Serono Inc ( Susan Fischer ) |
Study ID Numbers: | 25632 |
Study First Received: | May 6, 2005 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00110396 |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis Relapsing forms of multiple sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon beta 1a |
Interferon-beta Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |