Multiple SclerosisNCT02969304
Study of Utilization Patterns of Dimethyl Fumarate in Germany
An observational study of Multiple Sclerosis, run by Biogen at 1 site in Germany.
Trial summary
The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- dimethyl fumarate
- How many people
- 930 participants
- Where
- 1 siteGermany
- Study dates
- 30 Dec 2016to 2 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective analysis of a research database, which contains German sick fund claims, to assess the usage of dimethyl fumarate in Germany. The research database is comprised of German sick fund data, which is compiled by Gesundheitsforen Leipzig (GFL). This GFL database currently contains sick fund claims data for approximately 4 million patients, which accounts for approximately 5-6% of the total sick fund population in Germany.
Who may be able to join
- New users of dimethyl fumarate will be included in the analysis
Who cannot join
- Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany
The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.
Read the detailed description
Dimethyl fumarate will not be provided to participants as a part of this study.
- Conditions
- Multiple Sclerosis
- Being tested
- dimethyl fumarate
- Keywords
- Tecfidera, Off-label, Utilization
- Medical subject headings
- Multiple Sclerosis, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
Also called Tecfidera, DMF, BG00012
Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate
On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate
| Study group | Role | What they receive |
|---|---|---|
| Off-Label | Any DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis. Receives: Drug: dimethyl fumarate | |
| On-Label | Prescriptions for patients who are ≥18 years of age and diagnosed with MS Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Secondary outcomes (6)
Demographic characteristics of dimethyl fumarate users
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Prescription drug history of dimethyl fumarate users
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Duration of therapy in participants newly initiating dimethyl fumarate treatment
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Medical history of dimethyl fumarate users
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Concomitant medication use of dimethyl fumarate users
Measured: Up to 18 months after market introduction of dimethyl fumarate in Germany
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start30 Dec 2016
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969304
- Sponsor's protocol ID
- 109MS409
- Status last verified
- Jul 2017
- First submitted
- 21 Oct 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany
- ClinicalTrials.gov ID
- NCT02969304
- Acronym / sponsor ID
- 109MS409
- Conditions
- Multiple Sclerosis
- Keywords
- Tecfidera, Off-label, Utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 930 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 21 Nov 2016 (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 primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.
Detailed description
Dimethyl fumarate will not be provided to participants as a part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-Label | – | Drug: dimethyl fumarateAny DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis. |
| On-Label | – | Drug: dimethyl fumaratePrescriptions for patients who are ≥18 years of age and diagnosed with MS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective analysis of a research database, which contains German sick fund claims, to assess the usage of dimethyl fumarate in Germany. The research database is comprised of German sick fund data, which is compiled by Gesundheitsforen Leipzig (GFL). This GFL database currently contains sick fund claims data for approximately 4 million patients, which accounts for approximately 5-6% of the total sick fund population in Germany.
Key inclusion criteria (1 listed)
- New users of dimethyl fumarate will be included in the analysis
Key exclusion criteria (2 listed)
- Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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 |
|---|---|---|
| dimethyl fumarateAlso: Tecfidera, DMF, BG00012Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate | Drug | Off-Label, On-Label |
Primary outcome
Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
6 secondary outcomes
Demographic characteristics of dimethyl fumarate users
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Prescription drug history of dimethyl fumarate users
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Duration of therapy in participants newly initiating dimethyl fumarate treatment
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Medical history of dimethyl fumarate users
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Concomitant medication use of dimethyl fumarate users
Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
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 19 Jul 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.
Medical Director study director
Biogen
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 Multiple Sclerosis, run by Biogen at 1 site in Germany.
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 1 inclusion and 2 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 19 Jul 2017. 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 Germany. 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?
Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany (time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany). 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 19 Jul 2017.