Rebif New Formulation (RNF) Quality of Life (QOL) Study

Study 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).

Official Title
-----------------
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)

Conditions
-----------------
Relapsing Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Rebif New Formulation Non Titrated
* Drug: Rebif New Formulation Titrated


Participation Criteria
=================
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 1. 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. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal. Subject suffers from other current autoimmune disease. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol Subject is pregnant or attempting to conceive Visual or physical impairment that precludes completion of diaries and questionnaires.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Rebif New Formulation - Non Titrated | Drug: Rebif New Formulation Non Titrated<br>* human interferon beta 1a - Rebif New Formulation<br>|
| Active Comparator: 2<br>Rebif New Formulation - Titrated | Drug: Rebif New Formulation Titrated<br>* Human interferon beta 1a Rebif New Formulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) | 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. | % change from Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). | 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) | The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 - score at baseline. | Baseline to Week 12 | 
| Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 | The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain). | Baseline to Week 12 | 
| Tolerability in Pain Using Visual Analog Scale (VAS) | The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free. | Baseline to Week 12 | 
| Tolerability - Redness at Injection Site | Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better. | Baseline to Week 12 (LOCF) |