Multiple SclerosisTERIPETNCT03368677
Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of Progression
An observational study of Multiple Sclerosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2017to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The research will recruit MS patients who are using teriflunomide treatment and are followed-up at the Neurology Outpatient Clinic at the Turku University Hospital. The study will not interfere with the initiation or dosage of the medication in any manner. The patient's treating neurologist will select the most suitable medication on the basis of the patient's clinical status, and patients using teriflunomide medication will be offered the option to participate in this imaging research.
Who may be able to join
- Signing the consent form
- Having used teriflunomide treatment for at least 6 months
- 40-55 years of age at the time of signing the research consent form
- MS diagnosis in accordance with either the Poser or McDonald criteria
- EDSS 2-6.5
- Clear lesion load in brain MRI (> 9 T2 lesion)
Who cannot join
- Patients suffering from another brain disease of in addition to multiple sclerosis
- Steroid treatment 4 weeks prior to the scan
- Significant pathology in the MRI scan other than MS-related lesions
- Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
- Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
- Severe hepatic impairment
- Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting SPMS: Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of Progression. A [11C]PK11195 Brain PET Study
To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis.
Read the detailed description
In Multiple Sclerosis (MS), plaques in the white and grey matter of the brain represent the best known pathological changes of the disease, but a significant inflammation process has also been detected outside these plaques in connection with the disease. This extensive, diffuse inflammatory process correlates with the progression of the disease, measured by EDSS score (Expanded Disability Status Scale status) and reduction in patients' cognitive level. According to neuropathological research, the diffuse inflammatory process outside the plaques is connected with powerful activation of microglia, oxidative stress, and deficiencies in mitochondrial activity. The activation of microglial cells can be measured in vivo in patients using positron-emission tomography (PET) scanning and so-called TSPO radioligands, such as the 11C-PK11195 radioligand. 11C-PK11195 radioligand binds to TSPO molecules, which manifest on the surface of activated, but not un-activated, microglia.
Teriflunomide treatment is expected to slow down the process of increasing microglial activation. TSPO-PET imaging allows in vivo follow-up of the pathogenic process associated with the gradual MS disease evolution, and allows to evaluate whether teriflunomide treatment has an effect on disease progression-related pathology.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
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 |
|---|---|---|
| Teriflunomide group | 20 MS patients who are using teriflunomide medication under the supervision of their treating neurologist. | |
| No disease modifying treatment | 10 MS-patients who do not use any regular disease modifying MS treatment of their own volition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 11C-PK11195-radioligand binding using PET
Change in microglia-activity in late RRMS patients on teriflunomide treatment during one-year interval as measured by PET imaging and [11C]PK11195 radioligand.
Measured: 0 to 12 months
Secondary outcomes (3)
MRI metrics
To evaluate lesion load of the white matter MS plaques
Measured: 0, 12 months, 24 months, 36 months
EDSS
Expanded Disability Status Scale
Measured: 0, 12 months, 24 months, 36 months
BICAMS
Brief International Cognitive Assessment for MS
Measured: 0, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Dec 2017
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
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 Turku University HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Airas, MD,professor, Principal investigator, Turku University Hospital, division of clinical neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368677
- Sponsor's protocol ID
- TERIPET
- Acronym
- TERIPET
- Status last verified
- Apr 2025
- First submitted
- 2 Oct 2017
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sjoros T, Saraste M, Matilainen M, Nylund M, Koivumaki M, Kuhle J, Leppert D, Airas L. Serum glial fibrillary acid protein associates with TSPO-expressing lesions in multiple sclerosis brain. Ther Adv Neurol Disord. 2025 Jul 28;18:17562864251352998. doi: 10.1177/17562864251352998. eCollection 2025.
PubMed 40756531
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting SPMS: Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of Progression. A [11C]PK11195 Brain PET Study
- ClinicalTrials.gov ID
- NCT03368677
- Acronym / sponsor ID
- TERIPET / TERIPET
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Dec 2017 (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.
To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis.
Detailed description
In Multiple Sclerosis (MS), plaques in the white and grey matter of the brain represent the best known pathological changes of the disease, but a significant inflammation process has also been detected outside these plaques in connection with the disease. This extensive, diffuse inflammatory process correlates with the progression of the disease, measured by EDSS score (Expanded Disability Status Scale status) and reduction in patients' cognitive level. According to neuropathological research, the diffuse inflammatory process outside the plaques is connected with powerful activation of microglia, oxidative stress, and deficiencies in mitochondrial activity. The activation of microglial cells can be measured in vivo in patients using positron-emission tomography (PET) scanning and so-called TSPO radioligands, such as the 11C-PK11195 radioligand. 11C-PK11195 radioligand binds to TSPO molecules, which manifest on the surface of activated, but not un-activated, microglia.
Teriflunomide treatment is expected to slow down the process of increasing microglial activation. TSPO-PET imaging allows in vivo follow-up of the pathogenic process associated with the gradual MS disease evolution, and allows to evaluate whether teriflunomide treatment has an effect on disease progression-related pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide group | – | –20 MS patients who are using teriflunomide medication under the supervision of their treating neurologist. |
| No disease modifying treatment | – | –10 MS-patients who do not use any regular disease modifying MS treatment of their own volition |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The research will recruit MS patients who are using teriflunomide treatment and are followed-up at the Neurology Outpatient Clinic at the Turku University Hospital. The study will not interfere with the initiation or dosage of the medication in any manner. The patient's treating neurologist will select the most suitable medication on the basis of the patient's clinical status, and patients using teriflunomide medication will be offered the option to participate in this imaging research.
Key inclusion criteria (6 listed)
- Signing the consent form
- Having used teriflunomide treatment for at least 6 months
- 40-55 years of age at the time of signing the research consent form
- MS diagnosis in accordance with either the Poser or McDonald criteria
- EDSS 2-6.5
Key exclusion criteria (7 listed)
- Patients suffering from another brain disease of in addition to multiple sclerosis
- Steroid treatment 4 weeks prior to the scan
- Significant pathology in the MRI scan other than MS-related lesions
- Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
- Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to 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
Change of 11C-PK11195-radioligand binding using PET
Time frame: 0 to 12 months
Change in microglia-activity in late RRMS patients on teriflunomide treatment during one-year interval as measured by PET imaging and [11C]PK11195 radioligand.
3 secondary outcomes
MRI metrics
Time frame: 0, 12 months, 24 months, 36 months
EDSS
Time frame: 0, 12 months, 24 months, 36 months
BICAMS
Time frame: 0, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 40756531Sjoros T, Saraste M, Matilainen M, Nylund M, Koivumaki M, Kuhle J, Leppert D, Airas L. Serum glial fibrillary acid protein associates with TSPO-expressing lesions in multiple sclerosis brain. Ther Adv Neurol Disord. 2025 Jul 28;18:17562864251352998. doi: 10.1177/17562864251352998. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Laura Airas, MD,professor principal investigator
Turku University Hospital, division of clinical neurosciences
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 Turku University Hospital at 1 site in Finland.
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2025. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change of 11C-PK11195-radioligand binding using PET (time frame: 0 to 12 months). 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 NCT03368677, 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 13 Apr 2025.