NCT00367484

Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple Sclerosis

Multicentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study are: \- comparison of the incidence and time course of the development of neutralizing antibodies (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif®

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Rebif® (clone 484-39)	s.c. administered Rebif®

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2006-08-23
• Last updated: 2014-02-27
• Results posted: 2010-08-27