Clinical trial NCT02117050: RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
Official 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Rebif ®
Tecfidera ™
treatment change
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering discontinuing treatment with Tecfidera™.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24
timeFrame: Baseline, Week 24
measure: 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
timeFrame: Baseline, Week 24
measure: Annualized Relapse Rate (ARR)
timeFrame: Week 24
Other outcomes:
Locations:
city: Boston
country: United States
facility: Call EMD Serono Medical Information for information on recruiting sites
state: Massachusetts
Study officials:
affiliation: EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible, MD
role: STUDY_DIRECTOR
References: