Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients

Completed

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: Rebif

• Registration Number: NCT01601119
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

The objective is to establish the impact of current disease modifying therapies (DMTs) and associated support services on Patient Reported Experience Measures and Patient Reported Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the United Kingdom (UK).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

Inclusion Criteria

• Relapsing Multiple Sclerosis patients aged 18 years or over.
• Naive to previous DMT therapy and not yet started treatment with a disease modifying therapy.

Exclusion Criteria

• Participating in an MS-related clinical trial.
• Unwilling to provide electronic online consent.
• Any disability that may impair them from being able to complete the online questionnaire.
• Do not have regular access to the Internet.
• Unable to complete the baseline questionnaire before they receive their first DMT injection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rebif cohort	Rebif	Subject will receive Rebif as the treatment medication as per the standard or current practices or as directed by the healthcare professional. Allocation of subjects to a specific cohort was based on the first DMT they will be prescribed regardless of any subsequent treatment switches.

Primary Outcome Measures

Name	Time	Method
Treatment Satisfaction	96 weeks	The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.

Secondary Outcome Measures

Name	Time	Method
Device satisfaction	96 weeks	Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) is an MS-specific treatment satisfaction questionnaire that evaluates injection system satisfaction and side effects.
Evaluation of support services	96 weeks	Patient evaluation of Manufacturer, Homecare and NHS support services
Work Productivity	96 weeks	Work Productivity and Activity Impairment (WPAI) Questionnaire
Health Related Quality of Life	96 weeks	Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire
Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire	96 weeks

Trial Locations

Locations (1)

Please contact the; 🇬🇧 Merck KGaA Communication Center for locations, United Kingdom