NCT01601119

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

2.5 years

First QC Date

May 15, 2012

Last Update Submit

May 28, 2015

Conditions

Relapsing Multiple Sclerosis

Keywords

Multiple SclerosisPatient reported outcomePatient reported experience

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Work Productivity

    96 weeks

  • Health Related Quality of Life

    96 weeks

  • Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire

    96 weeks

  • Device satisfaction

    96 weeks

  • Evaluation of support services

    96 weeks

Study Arms (2)

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.

Drug: Rebif

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: Other: Disease modifying therapies (DMT)

Interventions

RebifDRUG

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

Rebif cohort
Other: Disease modifying therapies (DMT)OTHER

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

Other DMT cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the UK newly diagnosed with RMS (and naive to previous DMT) and receiving a DMT that can be self-administered

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Please contact the

Merck KGaA Communication Center For Locations, United Kingdom

Location

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

Study Officials

  • Medical Director

    Merck Serono Limited, UK

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

GB(1)