A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)

EMD Serono1 site in 1 country232 target enrollmentApril 2007

ConditionsRelapsing Multiple Sclerosis

InterventionsRebif New Formulation Non Titrated Rebif New Formulation Titrated

DrugsRebif New Formulation Non Titrated Rebif New Formulation Titrated

Overview

Phase: Phase 3
Intervention: Rebif New Formulation Non Titrated
Conditions: Relapsing Multiple Sclerosis
Sponsor: EMD Serono
Enrollment: 232
Locations: 1
Primary Endpoint: Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

November 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EMD Serono

Eligibility Criteria

Inclusion Criteria

•Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
•Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
•Subject currently using Rebiject II and 29 gauge needle
•Subject is between 18 and 60 years old inclusive
•Subject is able to read and understand English
•Subject is willing to follow study procedures
•Subject has given written informed consent and signed HIPAA
•Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)

Exclusion Criteria

•Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
•Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
•Subjects who have previously been on Rebif New Formulation (RNF).
•Subject with progressive forms of Multiple Sclerosis (MS).
•Subject with history of any chronic pain syndrome.
•Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
•Subject has complete transverse myelitis or bilateral optic neuritis.
•Subjects that use any investigational drug or experimental procedure within 12 weeks of visit
•Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
•Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase \> 2.5 times the upper limit of the normal values.

Arms & Interventions

1

Rebif New Formulation - Non Titrated

Intervention: Rebif New Formulation Non Titrated

2

Rebif New Formulation - Titrated

Intervention: Rebif New Formulation Titrated

Outcomes

Primary Outcomes

Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)

Time Frame: % change from Baseline to Week 12

The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 \& 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% \* (score at week 12 - score at baseline) / score at baseline.

Secondary Outcomes

Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)(Baseline and Week 12)
Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)(Baseline to Week 12)
Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12(Baseline to Week 12)
Tolerability in Pain Using Visual Analog Scale (VAS)(Baseline to Week 12)
Tolerability - Redness at Injection Site(Baseline to Week 12 (LOCF))