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

NCT00367484 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2014-02-27

Study results available
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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

BIOLOGICAL

Rebif® (clone 484-39)

s.c. administered Rebif®

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Bettina Stubinski, M.D. · Merck Serono SA - Geneva

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-01-31
Completion
2006-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00367484 on ClinicalTrials.gov