Multiple Sclerosis, Relapsing-RemittingNCT02598167
Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Hoffmann-La Roche at 18 sites in Spain.
Trial summary
This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 223 participants
- Where
- 18 sitesSpain
- Study dates
- 7 Dec 2015to 23 Feb 2016
- 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: Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months
Who may be able to join
- Participants aged greater than or equal to (>/=) 18 years
- Participants who have a diagnosis of RRMS as documented in their medical records
- Participants who have been prescribed a DMT for at least 3 months
- Participants who have an expanded disability status scale (EDSS) score of 1-6 points
Who cannot join
- Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital Universitario del Sureste; Servicio de Neurologia
Arganda, Madrid, 28500
Hospital del Mar; Servicio de Neurologia
Barcelona, 08003
Hospital General de Castellon; Servicio de Neurología
Castellon, Castellon, 12004
Hospital Universitario Reina Sofia; Servicio de Neurologia
Córdoba, 14011
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
Girona, 17007
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
Lleida, Lerida, 25198
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
Madrid, 28007
Fundacion Jimenez Diaz; Servicio de Neurología
Madrid, 28040
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, 28041
Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología
Móstoles, Madrid, 28933
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario de Canarias; Servicio de Neurologia
San Cristóbal de La Laguna, Tenerife
Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología
Sant Joan Despí, Barcelona, 08970
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
Valencia, 46010
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, 46017
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Valencia, 46026
Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
Vigo, Pontevedra, 36312
About this study
Official title: Assessing Patients Preferences Towards Disease-modifying Therapeutic Options in Relapsing Remitting Multiple Sclerosis
This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RRMS Population | Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months according to standard local clinical practice will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
Measured: Up to 3 months
Percentage of Participants With DMT Administration Schedule Preferences
Measured: Up to 3 months
Percentage of Participants With DMT Route of Administration Preferences
Measured: Up to 3 months
DMT Efficacy Based on Annualized Relapse Rate
Measured: Up to 3 months
Secondary outcomes (11)
Participants Education Level
Measured: Baseline
Participants Employment Status
Measured: Baseline
Participants RRMS Disease Duration
Measured: Baseline
Number of Relapses of RRMS in Last 2 Years
Measured: Baseline
Duration since Last Relapse of RRMS
Measured: Baseline
Participants Current DMT for RRMS
Measured: Baseline
Number of Previous DMTs Taken Prior to Switch to Current DMT
Measured: Baseline
Expanded Disability Status Scale (EDSS) Score
Measured: Up to 3 months
Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score
Measured: Up to 3 months
Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score
Measured: Up to 3 months
Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start7 Dec 2015
- Primary completion23 Feb 2016
- Study completion23 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598167
- Sponsor's protocol ID
- ML29715
- Status last verified
- Oct 2017
- First submitted
- 4 Nov 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patients Preferences Towards Disease-modifying Therapeutic Options in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02598167
- Acronym / sponsor ID
- ML29715
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 23 Feb 2016 (actual)
- Study completion
- 23 Feb 2016 (actual)
- First posted
- 5 Nov 2015 (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.
This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRMS Population | – | –Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months according to standard local clinical practice will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months
Key inclusion criteria (4 listed)
- Participants aged greater than or equal to (>/=) 18 years
- Participants who have a diagnosis of RRMS as documented in their medical records
- Participants who have been prescribed a DMT for at least 3 months
- Participants who have an expanded disability status scale (EDSS) score of 1-6 points
Key exclusion criteria (1 listed)
- Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)
Time frame: Up to 3 months
Percentage of Participants With DMT Administration Schedule Preferences
Time frame: Up to 3 months
Percentage of Participants With DMT Route of Administration Preferences
Time frame: Up to 3 months
DMT Efficacy Based on Annualized Relapse Rate
Time frame: Up to 3 months
11 secondary outcomes
Participants Education Level
Time frame: Baseline
Participants Employment Status
Time frame: Baseline
Participants RRMS Disease Duration
Time frame: Baseline
Number of Relapses of RRMS in Last 2 Years
Time frame: Baseline
Duration since Last Relapse of RRMS
Time frame: Baseline
Participants Current DMT for RRMS
Time frame: Baseline
Number of Previous DMTs Taken Prior to Switch to Current DMT
Time frame: Baseline
Expanded Disability Status Scale (EDSS) Score
Time frame: Up to 3 months
Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score
Time frame: Up to 3 months
Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score
Time frame: Up to 3 months
Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score
Time frame: Up to 3 months
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 25 Oct 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Hoffmann-La Roche at 18 sites in Spain.
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 4 inclusion and 1 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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. 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?
Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe) (time frame: Up to 3 months). The study lists 4 primary outcomes in all. 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 25 Oct 2017.