Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT04239820
Eligibility Criteria:
Inclusion Criteria:
* Signing the informed consent form
* Cladribine treatment is planned and indicated and is according to label
* 45-55 years of age at the time of signing the research informed consent form
* RRMS diagnosis in accordance with McDonald 2017 criteria
Exclusion Criteria:
* 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)
* Patients with less than 1 month since previous administration of other disease modifying therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
55 Years
Study:
NCT04239820
Study Brief:
Protocol Section:
NCT04239820