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

Relapsing Multiple Sclerosis Clinical Trial

Official title:

The Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601119
• Other study ID #: EMR200136_550
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: May 28, 2015
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Rebif
The subjects will receive Rebif as per the current practices or as directed by the physician.

Other:
• Other: Disease modifying therapies (DMT)
The subjects will receive other DMTs as per the current practices or as directed by the physician.

Locations

Country	Name	City	State
United Kingdom	Please contact the	Merck KGaA Communication Center for locations

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Limited, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction	The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.	96 weeks	No
Secondary	Work Productivity	Work Productivity and Activity Impairment (WPAI) Questionnaire	96 weeks	No
Secondary	Health Related Quality of Life	Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire	96 weeks	No
Secondary	Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire		96 weeks	No
Secondary	Device satisfaction	Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) is an MS-specific treatment satisfaction questionnaire that evaluates injection system satisfaction and side effects.	96 weeks	No
Secondary	Evaluation of support services	Patient evaluation of Manufacturer, Homecare and NHS support services	96 weeks	No