Effect of Cladribine Treatment on Microglial Activation in the CNS

NCT04239820 | Active Not Recruiting

• 2 other identifiers: 142/20192019-001960-31
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of cladribine treatment on microglial activation with conventional MRI, QSM-post processing and TSPO-PET imaging in late stage relapsing remitting multiple sclerosis patients.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 11C-PK11195 binding in MS patient brain

  Change in microglia-activity in MS patients during 18 months as measured by 11C-PK11195 PET imaging

  baseline, 18 months

Secondary Outcomes (6)

• MRI metrics

  Baseline, 18 months

• Expanded Disability Status Scale

  Baseline, 18 months

• Multiple Sclerosis Composite Score

  Baseline, 18 months

• Blood biomarkers

  Baseline, 18 months

• 11C-PK11195 difference in RRMS and historical healthy controls

  Baseline, 18 months

Study Arms (1)

RRMS patients initiating cladribine

Patients will be imaged using PET and MRI at baseline prior the cladribine treatment initiation and 18 months after baseline

Radiation: Imaging

Interventions

Imaging RADIATION

MRI and TSPO-PET imaging at baseline and 18 months after baseline

RRMS patients initiating cladribine

Eligibility Criteria

• Age: 45 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 initiating cladribine treatment and are followed-up at the Neurology Outpatient Clinic at the areas of the Hospital District of Southwest Finland, Helsinki and Uusimaa Hospital District, Pirkanmaa Hospital District and Satakunta Hospital District. 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 initiating cladribine medication will be offered the option to participate in this imaging study.

You may qualify if:

• Signing the informed consent form
• Cladribine treatment is planned and indicated and is according to label
• years of age at the time of signing the research informed consent form
• RRMS diagnosis in accordance with McDonald 2017 criteria

You may not qualify if:

• Patients with other neurodegenerative disease than MS
• Abnormal lymphocyte counts
• Patients with human immunodeficiency virus (HIV).
• Patients with active chronic infection (tuberculosis or hepatitis).
• Patients with active malignancy.
• Patients with moderate or severe renal impairment (creatinine clearance \<60 mL/min)
• Patients that are pregnant or breast-feeding
• Corticosteroid treatment within 4 weeks of imaging
• Patients with significant abnormal findings other than MS in the screening MRI.
• Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
• Contraindication to PET scan investigations
• Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
• Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
• Patients with previous alemtuzumab administration
• Patients with less than 6 months since previous administration of ocrelizumab or rituximab (or with abnormal B-cell counts)

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 samples

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Laura Airas, Professor

  Turku University Hospital, division of clinical neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: January 10, 2020
• Primary Completion: February 15, 2024
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

FI (1)