Plain English Summary
Background and study aims
This is a research study being carried out at six hospitals in the UK. It will look back over 3 years at how well patients with multiple sclerosis (MS) respond to medicines known as disease modifying therapies (DMTs), which are used to treat MS. We are also looking at the effect a relapse has on the everyday life of a person with MS. DMTs have all been tested in clinical trials and approved for treating patients, but in this study we want to get more information about the experience of patients using them. This study is designed to increase understanding of how well DMTs work as initial treatments for Relapsing Remitting MS (RRMS), in patients real-world setting rather than in formal clinical trials.
We understand the progression and accumulation of disability in the later stages of MS quite well, but the physical, psychological and financial impact of relapses in early disease is less clear and potentially underestimated. Differing perceptions between physicians and patients on the nature and severity of a relapse may contribute to this.
Who can participate?
Patients with a diagnosis of RRMS, and who started a DMT for the first time in 2008, will be eligible to participate.
What does the study involve?
Patients will be identified at 6 UK centres and will be invited to participate by post. They will be sent an information sheet, and details of a person to contact if they require further information. Once the consent has been returned (by post), the participant will be enrolled in the study and will receive another package by post. Included in this pack are a retrospective questionnaire to provide information on the participants experience of their last relapse, and three short questionnaires to inform us of their current health status. Once this is returned, the participant will have completed their role in study.
We will also look at the medical records of those who allow us to do so. We will look at the number of relapses that occur in the 3 years after the first prescription of DMTs, any changes in medication, and the number of clinic visits needed during this time.
What are the possible benefits and risks of participating?
There are no direct risks or benefits to the participant in this study as there will be no change in patient care. The benefit is adding to the literature in this area to inform clinical and policy decisions about patient care.
Where is the study run from?
This study is coordinated independently by pH Associates. The six centres taking part will be: The Royal Victoria Infirmary - Newcastle, Queens Hospital - Romford, Charing Cross Hospital - London, Leicester General Infirmary - Leicester, Norfolk and Norwich University Hospital Norwich, and Morristen Hospital - Swansea.
When is study starting and how long is it expected to run for?
May 2012 to December 2012.
Who is funding the study?
Novartis Pharmaceuticals UK Ltd (UK)
Who is the main contact?
Heather Davies
heather.davies@novartis.com
Lucinda Davies (pH Associates)
lucinda@phassociates.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CFTY720DGB02
Study information
Scientific title
A multi-centre observational study of relapsing-remitting multiple sclerosis (RRMS) treated with first disease modifying therapies (DMTs) in current UK clinical practice: patterns of clinical decision making and the patient experience of relapse
Acronym
Study hypothesis
To describe the number of documented relapses experienced by people with MS (PwMS) in the first 3 years following DMT initiation
Ethics approval
Yes - London-Bromley, approved 4th April 2012, ref: 12 LO 0248
Study design
Multi-centre observational study
Primary study design
Observational
Secondary study design
Other
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Condition
Multiple Sclerosis
Intervention
1. Retrospective questionnaire on the patients experience of the last relapse
2. Three short health questionnaires
3. Review of medical records over 3 years from the first prescription of a disease-modifying treatment for relapsing-remitting multiple sclerosis
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To describe the number of documented relapses experienced by patients with MS in the first 3 years following DMT initiation
Secondary outcome measures
1. To describe the number of documented relapses experienced by patients with MS in the 3 years following DMT initiation by severity
2. To describe the DMT prescribing patterns in the first three years following DMT initiation
3. To compare clinician-documented and patient-reported relapse symptoms
4. To describe the change in patient contact with health care professionals resulting from relapse
5. To describe the financial impact of a relapse on patients with MS
6. To describe the impact of a relapse on patients attitudes to DMT
Overall trial start date
01/06/2012
Overall trial end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with RRMS by 2005 MacDonald criteria
2. Patients initiated on DMT for the first time after 1 January 2008 and at least 36 months before date of screening for inclusion
3. Patients who consent to complete the questionnaire and for their medical records to be reviewed for the purposes of healthcare research
4. Patients who are able to complete the study questionnaires or have a carer who is able and willing to record the patients responses to the study questionnaires
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Patients who are unwilling or unable to provide patient consent
2. Patients who are unable to complete the study questionnaires themselves and have no appropriate carer able and willing to assist them
Recruitment start date
01/06/2012
Recruitment end date
01/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Novartis Pharmaceuticals UK Ltd
Frimley
GU16 7SR
United Kingdom
Sponsor information
Organisation
Novartis Pharmaceuticals Ltd (UK)
Sponsor details
c/o Dr Heather Davies
200 Frimley Business Park
Frimley
GU16 7SR
United Kingdom
+44 1276 694402
heather.davies@novartis.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Novartis Pharmaceuticals UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list