RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

Multiple Sclerosis Clinical Trial

— RESOunD  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02117050
• Other study ID #: EMR200136-586
• Status: Terminated
• Phase: Phase 4
• First received: April 15, 2014
• Last updated: June 3, 2015
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Rebif®
Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.

Locations

Country	Name	City	State
United States	Call EMD Serono Medical Information for information on recruiting sites	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline, Week 24	No
Secondary	Change from baseline in Patient-Determined Disease Steps Questionnaire (PDDS) score at Week 24		Baseline, Week 24	No
Secondary	Change from baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) score at Week 24		Baseline, Week 24	No
Secondary	Change from baseline in TSQM (Version II) - Total score at Week 12 and Week 24		Baseline, Week 12, and Week 24	No
Secondary	Change from baseline in TSQM (Version II) - Medication effectiveness, side effects, and convenience subscale scores at Week 24		Baseline, Week 24	No
Secondary	Change from baseline in TSQM (Version II) - Global satisfaction, medication effectiveness, side effects, and convenience subscale scores at Week 12		Baseline, Week 12	No
Secondary	Change from baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) questionnaire score at Week 24		Baseline, Week 24	No
Secondary	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		Baseline, Week 24	No
Secondary	Annualized Relapse Rate (ARR)		Week 24	No

External Links

•   The North American Research Committee on Multiple Sclerosis - Information about the PDDS Questionaire