RNF and Betaseron® Tolerability Study — REFORMS

Relapsing Remitting Multiple Sclerosis (RRMS) Clinical Trial

Official title:
A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Relapsing Remitting Multiple Sclerosis (RRMS)
Sclerosis

Clinical Trial Details

NCT number	NCT00428584
Study type	Interventional
Source	EMD Serono
Contact
Status	Completed
Phase	Phase 3
Start date	December 2006
Completion date	September 2009

View Details

See also
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Completed	`NCT05242133` - Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis	Phase 3
Completed	`NCT01125475` - A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects	N/A
Completed	`NCT00871780` - A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients	Phase 4
Completed	`NCT01235455` - Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors	N/A