Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of Progression

NCT03368677 | Active Not Recruiting

• 1 other identifier: TERIPET
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of teriflunomide treatment on microglial activation in late stage multiple sclerosis.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• MRI metrics

  0, 12 months, 24 months, 36 months

• EDSS

  0, 12 months, 24 months, 36 months

• BICAMS

  0, 36 months

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Signing the consent form
• Having used teriflunomide treatment for at least 6 months
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

Location

Related Publications (1)

• 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.

  PMID: 40756531 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and faecal samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Airas, MD,professor

  Turku University Hospital, division of clinical neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: December 11, 2017
• Study Start: December 1, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

FI (1)