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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) (RebiQoL)
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).
Details
| Lead sponsor | EMD Serono |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 232 |
| Start date | 2007-04 |
| Completion | 2009-11 |
Conditions
- Relapsing Multiple Sclerosis
Interventions
- Rebif New Formulation Non Titrated
- Rebif New Formulation Titrated
Primary outcomes
- Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) — % 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.
Countries
United States