Relapsing Multiple SclerosisNCT01601119
Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients
An observational study of Relapsing Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Rebif and Other: Disease modifying therapies (DMT)
- How many people
- 545 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the UK newly diagnosed with RMS (and naive to previous DMT) and receiving a DMT that can be self-administered
Who may be able to join
- Relapsing Multiple Sclerosis patients aged 18 years or over.
- Naive to previous DMT therapy and not yet started treatment with a disease modifying therapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Please contact the
Merck KGaA Communication Center For Locations
About this study
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
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).
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Rebif, Other: Disease modifying therapies (DMT)
- Keywords
- Multiple Sclerosis, Patient reported outcome, Patient reported experience
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebifDrug
The subjects will receive Rebif as per the current practices or as directed by the physician.
Other: Disease modifying therapies (DMT)Other
The subjects will receive other DMTs as per the current practices or as directed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Other: Disease modifying therapies (DMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction
The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.
Measured: 96 weeks
Secondary outcomes (5)
Work Productivity
Work Productivity and Activity Impairment (WPAI) Questionnaire
Measured: 96 weeks
Health Related Quality of Life
Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire
Measured: 96 weeks
Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire
Measured: 96 weeks
Device satisfaction
Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) is an MS-specific treatment satisfaction questionnaire that evaluates injection system satisfaction and side effects.
Measured: 96 weeks
Evaluation of support services
Patient evaluation of Manufacturer, Homecare and NHS support services
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Serono Limited, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601119
- Sponsor's protocol ID
- EMR200136_550
- Status last verified
- May 2015
- First submitted
- 15 May 2012
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01601119
- Acronym / sponsor ID
- EMR200136_550
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Patient reported outcome, Patient reported experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebif cohort | – | Drug: RebifSubject 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. |
| Other DMT cohort | – | Other: Other: Disease modifying therapies (DMT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the UK newly diagnosed with RMS (and naive to previous DMT) and receiving a DMT that can be self-administered
Key inclusion criteria (2 listed)
- Relapsing Multiple Sclerosis patients aged 18 years or over.
- Naive to previous DMT therapy and not yet started treatment with a disease modifying therapy.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebifThe subjects will receive Rebif as per the current practices or as directed by the physician. | Drug | Rebif cohort |
| Other: Disease modifying therapies (DMT)The subjects will receive other DMTs as per the current practices or as directed by the physician. | Other | Other DMT cohort |
Primary outcome
Treatment Satisfaction
Time frame: 96 weeks
The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.
5 secondary outcomes
Work Productivity
Time frame: 96 weeks
Health Related Quality of Life
Time frame: 96 weeks
Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire
Time frame: 96 weeks
Device satisfaction
Time frame: 96 weeks
Evaluation of support services
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Serono Limited, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.