MedTrace Logo

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

NCT00110396 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2015-07-15

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

Interferon-beta-1a FBS-free/HSA-free

Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.

Sponsors & Collaborators

Principal Investigators

  • Bettina Stubinski, MD · 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
2005-01-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00110396 on ClinicalTrials.gov