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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 6, 2005 | ||||
| Last Updated Date | March 21, 2009 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Proportion of subjects who are NAb positive at the Week 96 visit. [ Time Frame: At week 96 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Proportion of subjects who are NAb positive at the Week 96 visit. | ||||
| Change History | Complete list of historical versions of study NCT00110396 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The secondary endpoints include various antigenicity measurements. [ Time Frame: At various time points ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
The secondary endpoints include various antigenicity measurements. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rebif New Formulation 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® (IFN-Beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis | ||||
| Brief Summary | 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. |
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| 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. 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE | 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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| Study Arms / Comparison Groups | 1: Experimental
Intervention: Drug: Interferon-beta-1a FBS-free/HSA-free |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 230 | ||||
| Completion Date | November 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00110396 | ||||
| Responsible Party | Susan Fischer, EMD Serono Inc | ||||
| Study ID Numbers ICMJE | 25632 | ||||
| Study Sponsor ICMJE | EMD Serono | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | EMD Serono | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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