Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRI metrics | To evaluate lesion load of the white matter MS plaques | 0, 12 months, 24 months, 36 months |
| EDSS | Expanded Disability Status Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Airas, MD,professor | Turku University Hospital, division of clinical neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku PET Centre | Turku | Southwest Finland | 20520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40756531 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, urine and faecal samples
| 0, 12 months, 24 months, 36 months |
| BICAMS | Brief International Cognitive Assessment for MS | 0, 36 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |