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

NCT ID: NCT01601119

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

545 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Relapsing Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rebif cohort

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.

Rebif

Intervention Type DRUG

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

Other DMT cohort

Subjects will receive DMT other than Rebif 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.

Other: Disease modifying therapies (DMT)

Intervention Type OTHER

The subjects will receive other DMTs as per the current practices or as directed by the physician.

Interventions

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Rebif

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

Intervention Type DRUG

Other: Disease modifying therapies (DMT)

The subjects will receive other DMTs as per the current practices or as directed by the physician.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono Limited, UK

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Serono Limited, UK

Locations

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Please contact the

Merck KGaA Communication Center For Locations, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EMR200136_550

Identifier Type: -

Identifier Source: org_study_id

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