Cladribine for Relapsing-remitting multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Diagnosis of RRMS according to the 2017 revised McDonald criteria.\n- Disease activity within the preceding year in the form of: (a) a clinical relapse, and/or (b) evidence of ≥2 T2 lesions on MRI scan, and or (c) presence of gadolinium enhancing lesions on an MRI scan\n- Age 18 – 50 years (inclusive) of age\n- Disease duration ≤10 years (since MS diagnosis)\n- EDSS 0 – 5.5 (inclusive)\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of progressive MS.\n- Moderate or severe renal impairment. Estimated glomerular filtration rate (eGFR) <60.\n- Active malignancy\n- No prior exposure to varicella virus. This is assessed through varicella serology.\n- Vaccination within 4 weeks of first dose of study medication\n- Severe psychiatric condition.\n- Previous use of rituximab (or any other B-dell depleting monoclonal antibody) and/or cladribine\n- Pregnant or lactating women, s-HCG will be tested on all women at screening and in any situation where there is a reason to suspect pregnancy during the trial, e.g. delayed menstruation.\n- Unwilling to use contraception during the treatment period and the first year after completing the treatment course.\n- Patients having contraindication for or otherwise not compliant with MRI investigations.\n- Simultaneous treatment with other immunosuppressive drugs.\n- Infection with human immunodeficiency virus (HIV)\n- Active, severe infections (e.g. hepatitis or tuberculosis). Signs of infections are assessed before inclusion and each study-related infusion through clinical examination and further evaluated by laboratory and other relevant investigations in case of suspected ongoing infection.\n- Severe cardiac disorder. E.g. signs of congestive heart failure or coronary artery disease. This will be evaluated through clinical assessment before inclusion."}

Primary endpoints

• {"endpoint_text":"- The binary indicator of at least one treatment-related SAE (relationship ≥ possible) per participant.","definition_or_measurement_approach":"Binary indicator per participant based on recorded serious adverse events assessed for relationship to treatment (relationship ≥ possible) as reported in SAE reporting during follow-up."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with a new MRI lesion at end of follow-up; and the average number of new T2 lesions per patient.","definition_or_measurement_approach":"Measured by MRI at end of follow-up: proportion with any new lesion; count and average number of new T2 lesions per patient."}
• {"endpoint_text":"- Proportion of patients with a new relapse; and the proportion of patients with a steroid-treated relapse; and the annualized relapse rate during follow-up,","definition_or_measurement_approach":"Relapse events recorded during follow-up; proportion with any relapse, proportion with steroid-treated relapses, and calculation of annualized relapse rate over follow-up period."}
• {"endpoint_text":"- Proportion of patients with confirmed disability worsening; and the average change in EDSS (Expanded Disability Status Scale); and proportion of patients with worsened/unchanged/improved SDMT; and the average change in SDMT.","definition_or_measurement_approach":"Disability assessed by EDSS with calculation of proportion with confirmed worsening and average change; cognition measured by SDMT with categorisation (worsened/unchanged/improved) and average change."}
• {"endpoint_text":"- The average change in pNfL and pGFAp.","definition_or_measurement_approach":"Biomarker assays for plasma neurofilament light (pNfL) and plasma glial fibrillary acidic protein (pGFAp) with calculation of average change from baseline."}
• {"endpoint_text":"- Proportion of patients with improved MSIS-29; and the average change in MSIS-29.","definition_or_measurement_approach":"Patient-reported outcome MSIS-29 assessed change and proportion improving; average change computed."}
• {"endpoint_text":"- Proportion of patients with mild/moderate adverse events with at least a probable relationship to the study medication (adverse reaction)","definition_or_measurement_approach":"Adverse events collected and assessed for relationship; proportion with mild/moderate events judged at least probably related to study medication."}

Sweden

Earliest CTIS Part Ii Submission Date

06-10-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

16

Number Of Sites

4

Number Of Participants

50

Primary sponsor

Full Name

Region Uppsala

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden