Multiple SclerosisMS; FTY720NCT06705608
Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study
An observational study of Multiple Sclerosis and Skin Cancer, run by University of British Columbia.
Trial summary
The goal of this retrospective observational study is to investigate the long-term safety of Fingolimod in individuals with Multiple Sclerosis (MS), specifically focusing on the risk of developing skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Skin Cancer, Skin Cancer Melanoma
- What is being tested?
- Fingolimod, Natalizumab and Dimethyl fumarate (DMF)
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 31 Dec 2020
- 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: Individuals diagnosed with MS at age 18 or older who received fingolimod, natalizumab, alemtuzumab, DMF, or teriflunomide for the treatment of relapsing-remitting MS between 2003 and 2020.
Who may be able to join
- Identified MS cohort with hospital/physician and prescription claims classified according to the international classification of disease codes and drug identification numbers respectively, using a validated case definition. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounter, outpatient encounter, or DMT dispensation) for MS in a 1-year window
- MS patients who initiated and used fingolimod, natalizumab, alemtuzumab, dimethyl fumarate, or teriflunomide as monotherapy following MS identification.
Who cannot join
- Pediatric (<18 years old) MS cases.
- MS cases with less than three years of baseline data before the first drug dispensation.
- MS cases with skin cancer in the three-year baseline period
About this study
Official title: Fingolimod and Risk of Skin Cancer Among Individuals with Multiple Sclerosis: a Population-based Cohort Study
The goal of this retrospective observational study is to investigate the long-term safety of Fingolimod in individuals with Multiple Sclerosis (MS), specifically focusing on the risk of developing skin cancer. The main question it aims to answer is:
- Does the use of Fingolimod increase the incidence of skin cancer in individuals with MS compared to those using other disease-modifying therapies? Participants who are new users of Fingolimod or other active comparators as part of their regular medical care for MS will be included in this study. Researchers will use advanced causal inference techniques to analyze healthcare data and compare the incidence of skin cancer between these groups.
- Conditions
- Multiple Sclerosis, Skin Cancer, Skin Cancer Melanoma, Skin Cancers - Basal Cell Carcinoma, Skin Cancer, Squamous Cell, Multiple Sclerosis (MS) - Relapsing-remitting
- Being tested
- Fingolimod, Natalizumab, Dimethyl fumarate (DMF), Alemtuzumab, Teriflunomide
- Keywords
- multiple sclerosis and skin cancer, fingolimod, disease modifying therapy, FTY720, fingolimod and skin cancer
- Medical subject headings
- Multiple Sclerosis, Skin Neoplasms, Melanoma, Carcinoma, Basal Cell, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
patients who received fingolimod for treating RRMS
NatalizumabDrug
patients who received natalizumab for treating RRMS (active comparator)
Dimethyl fumarate (DMF)Drug
patients who received dimethyl fumarate for treating RRMS (active comparator)
AlemtuzumabDrug
patients who received alemtuzumab for treating RRMS (active comparator)
TeriflunomideDrug
patients who received teriflunomide for treating RRMS (active comparator)
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with multiple sclerosis | Adult participants with Multiple Sclerosis (MS), identified through a validated case definition, were observed in this retrospective cohort study. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounters, outpatient encounter, or disease-modifying-therapy (DMT) dispensation) for MS in a 1-year window. In this study, administrative claims data of participants between 2003 to 2020 were evaluated. The lower bound of this time period was selected based on data availability for the main drugs of interest. MS patients who initiated treatment with fingolimod or the active comparator drugs were identified to compare the incidence of skin cancer. Receives: Drug: Fingolimod; Drug: Natalizumab; Drug: Dimethyl fumarate (DMF); Drug: Alemtuzumab; Drug: Teriflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who developed skin cancer
In this outcome measure, participants who developed skin cancer after receiving the respective DMT treatments are reported. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.
Measured: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.
Time to development of skin cancer
Time to development of skin cancer is defined as the time from the index date (drug initiation) to the development of skin cancer. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.
Measured: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2003
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacquelyn Cragg, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705608
- Sponsor's protocol ID
- H24-03199
- Acronym
- MS; FTY720
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia A, Kuramoto L, Khakban A, Sio WS, Traboulsee A, De Vera MA, Oh J, Loree J, Tam R, Lynd LD, Cragg JJ. Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol. BMJ Open. 2025 Jan 23;15(1):e088924. doi: 10.1136/bmjopen-2024-088924.
PubMed 39855661
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fingolimod and Risk of Skin Cancer Among Individuals with Multiple Sclerosis: a Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT06705608
- Acronym / sponsor ID
- MS; FTY720 / H24-03199
- Conditions
- Multiple Sclerosis, Skin Cancer, Skin Cancer Melanoma, Skin Cancers - Basal Cell Carcinoma, Skin Cancer, Squamous Cell, Multiple Sclerosis (MS) - Relapsing-remitting
- Keywords
- multiple sclerosis and skin cancer, fingolimod, disease modifying therapy, FTY720, fingolimod and skin cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Nov 2024 (actual)
- 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 goal of this retrospective observational study is to investigate the long-term safety of Fingolimod in individuals with Multiple Sclerosis (MS), specifically focusing on the risk of developing skin cancer. The main question it aims to answer is:
- Does the use of Fingolimod increase the incidence of skin cancer in individuals with MS compared to those using other disease-modifying therapies? Participants who are new users of Fingolimod or other active comparators as part of their regular medical care for MS will be included in this study. Researchers will use advanced causal inference techniques to analyze healthcare data and compare the incidence of skin cancer between these groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with multiple sclerosis | – | Drug: Fingolimod, Drug: Natalizumab, Drug: Dimethyl fumarate (DMF), Drug: Alemtuzumab, Drug: TeriflunomideAdult participants with Multiple Sclerosis (MS), identified through a validated case definition, were observed in this retrospective cohort study. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounters, outpatient encounter, or disease-modifying-therapy (DMT) dispensation) for MS in a 1-year window. In this study, administrative claims data of participants between 2003 to 2020 were evaluated. The lower bound of this time period was selected based on data availability for the main drugs of interest. MS patients who initiated treatment with fingolimod or the active comparator drugs were identified to compare the incidence of skin cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with MS at age 18 or older who received fingolimod, natalizumab, alemtuzumab, DMF, or teriflunomide for the treatment of relapsing-remitting MS between 2003 and 2020.
Key inclusion criteria (2 listed)
- Identified MS cohort with hospital/physician and prescription claims classified according to the international classification of disease codes and drug identification numbers respectively, using a validated case definition. This case definition requires an individual to have at least three health care encounters (any combination of inpatient encounter, outpatient encounter, or DMT dispensation) for MS in a 1-year window
- MS patients who initiated and used fingolimod, natalizumab, alemtuzumab, dimethyl fumarate, or teriflunomide as monotherapy following MS identification.
Key exclusion criteria (3 listed)
- Pediatric (<18 years old) MS cases.
- MS cases with less than three years of baseline data before the first drug dispensation.
- MS cases with skin cancer in the three-year baseline period
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 |
|---|---|---|
| Fingolimodpatients who received fingolimod for treating RRMS | Drug | Adult patients with multiple sclerosis |
| Natalizumabpatients who received natalizumab for treating RRMS (active comparator) | Drug | Adult patients with multiple sclerosis |
| Dimethyl fumarate (DMF)patients who received dimethyl fumarate for treating RRMS (active comparator) | Drug | Adult patients with multiple sclerosis |
| Alemtuzumabpatients who received alemtuzumab for treating RRMS (active comparator) | Drug | Adult patients with multiple sclerosis |
| Teriflunomidepatients who received teriflunomide for treating RRMS (active comparator) | Drug | Adult patients with multiple sclerosis |
Primary outcome
Number of participants who developed skin cancer
Time frame: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.
In this outcome measure, participants who developed skin cancer after receiving the respective DMT treatments are reported. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.
Time to development of skin cancer
Time frame: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.
Time to development of skin cancer is defined as the time from the index date (drug initiation) to the development of skin cancer. ICD 9/10 codes were used for the diagnosis of skin cancer (melanoma and non-melanoma skin cancers). Skin cancers were treated as a composite outcome of basal cell carcinoma, squamous cell carcinoma, and melanoma, as well as disaggregated by skin cancer subtypes.
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 26 Nov 2024.
- Derived from this study: PubMed 39855661Jia A, Kuramoto L, Khakban A, Sio WS, Traboulsee A, De Vera MA, Oh J, Loree J, Tam R, Lynd LD, Cragg JJ. Fingolimod and risk of skin cancer among individuals with multiple sclerosis: a population-based cohort study protocol. BMJ Open. 2025 Jan 23;15(1):e088924. doi: 10.1136/bmjopen-2024-088924.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Skin Cancer, run by University of British Columbia.
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 3 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants who developed skin cancer (time frame: From Index drug dispensation to the first of the following events, whichever occurred first: development of skin cancer; lost to follow-up; death; administrative end of follow-up; initiation of a comparator drug, assessed up to 180 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705608, which also lists 1 linked publication.
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 26 Nov 2024.