EMD Serono, Inc.
Rockland, Massachusetts, 02370, United States
NCT Number: NCT00472797
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).
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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Rockland, Massachusetts, 02370, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
human interferon beta 1a - Rebif New Formulation
Human interferon beta 1a Rebif New Formulation
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.
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).
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.
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).
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.
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.
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.
EMD Serono
Industry
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)
Acronym: RebiQoL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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