RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02117050
• Date of registration: 15/04/2014
• Prospective Registration: Yes
• Primary sponsor: EMD Serono
• Public title: RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate RESOunD
• Scientific title: RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)
• Date of first enrolment: June 2014
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02117050
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Medical Responsible, MD
• Affiliation: EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion criteria

Key inclusion Criteria:

- Diagnosis of relapsing form of MS

- Have declared a desire/plan to discontinue treatment with Tecfidera due to
tolerability issues and/or lack of efficacy

- Expanded Disability Status Scale (EDSS) score 0 to 5.0 inclusive

- Other protocol defined inclusion criteria could apply

Key exclusion Criteria:

- Pregnant or lactating

- Significant renal or hepatic impairment or other significant disease that would
compromise adherence and completion of the trial

- Other protocol defined exclusion criteria could apply



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Rebif®

Primary Outcome(s)

Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24 [Time Frame: Baseline, Week 24]

Secondary Outcome(s)

Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24 [Time Frame: Baseline, Week 24]

Annualized Relapse Rate (ARR) [Time Frame: Week 24]

Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24 [Time Frame: Baseline, Week 12 and Week 24]

Secondary ID(s)

EMR200136-586

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02117050