Rebif New Formulation (RNF) Quality of Life (QOL) Study (RebiQoL)
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|ClinicalTrials.gov Identifier: NCT00472797|
Recruitment Status : Completed
First Posted : May 14, 2007
Results First Posted : September 2, 2009
Last Update Posted : August 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Multiple Sclerosis||Drug: Rebif New Formulation Non Titrated Drug: Rebif New Formulation Titrated||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||232 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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)|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||November 2009|
Active Comparator: 1
Rebif New Formulation - Non Titrated
Drug: Rebif New Formulation Non Titrated
human interferon beta 1a - Rebif New Formulation
Active Comparator: 2
Rebif New Formulation - Titrated
Drug: Rebif New Formulation Titrated
Human interferon beta 1a Rebif New Formulation
- 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.
- Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) [ Time Frame: Baseline and Week 12 ]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).
- Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) [ Time Frame: Baseline to Week 12 ]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.
- Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 [ Time Frame: Baseline to Week 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).
- Tolerability in Pain Using Visual Analog Scale (VAS) [ Time Frame: Baseline to Week 12 ]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.
- Tolerability - Redness at Injection Site [ Time Frame: Baseline to Week 12 (LOCF) ]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.
- SF-36 Physical and Mental Component Scores [ Time Frame: Change from Baseline to Each Visit ]Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472797
|United States, Massachusetts|
|EMD Serono, Inc.|
|Rockland, Massachusetts, United States, 02370|
|Study Director:||Fernando Dangond, MD||EMD Serono|