NCT00110396

Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Interferon-beta-1a FBS-free/HSA-free	Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-05-09
• Last updated: 2015-07-15
• Results posted: 2010-07-09

Locations

1 site across 1 country: United States