NCT02117050

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™.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4 multiple-sclerosis

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

April 15, 2014

Results QC Date

November 28, 2016

Last Update Submit

November 28, 2016

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisRebif ®Tecfidera ™treatment change

Outcome Measures

Primary Outcomes (1)

  • 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

    The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Global satisfaction sub-scale of TSQM was to be used to measure overall satisfaction with medication using a 100-point scale. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 0 to 100, where higher scores indicated greater satisfaction.

    Baseline, Week 24

Secondary Outcomes (8)

  • Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24

    Baseline, Week 24

  • Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24

    Baseline, Week 24

  • Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24

    Baseline, Week 12 and Week 24

  • Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24

    Baseline, Week 24

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

    Baseline, Week 12

  • +3 more secondary outcomes

Study Arms (1)

Rebif® via Rebidose® auto-injector

EXPERIMENTAL
Drug: Rebif®

Interventions

Rebif®DRUG

Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (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.

Also known as: interferon-beta-1a
Rebif® via Rebidose® auto-injector

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Call EMD Serono Medical Information for information on recruiting sites

Boston, Massachusetts, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Limitations and Caveats

The study was prematurely terminated due to enrollment issues. Only 1 subject was enrolled in this study, but did not receive any dose. Neither efficacy nor safety analysis was done for the study.

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Serono, a division of Merck KGaA
service@merckgroup.com
+49-6151-72-5200

Study Officials

  • Medical Responsible, MD

    EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 17, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 23, 2017

Results First Posted

January 23, 2017

Record last verified: 2016-11

Locations

US(1)