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RNF and Betaseron® Tolerability Study

NCT00428584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2013-08-07

Study results available
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Summary

To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.

Conditions

  • Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

New Formulation of rebif - human interferon beta-1a

New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.

DRUG

Interferon beta -1b

Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.

Sponsors & Collaborators

Principal Investigators

  • Fernando Dangond, MD · EMD Serono

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-11-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT00428584 on ClinicalTrials.gov