Switching from anti-CD20 therapies to Cladribine in relapsing MS patients
Consolidation Therapy with Immune Reconstitution Therapy (cladribine) in Relapsing Multiple Sclerosis Patients Following a Treatment with Anti-CD20 Compounds: a Pivotal Study
This study tests whether switching from anti-CD20 treatments to Cladribine can improve health and reduce infection risks for patients with relapsing multiple sclerosis who have had problems with their current medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Drugs / interventions | ocrelizumab, rituximab |
| Locations | 1 site (Lugano, Ticino) |
| Trial ID | NCT06854094 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of switching from anti-CD20 therapies, such as ocrelizumab or rituximab, to Cladribine in patients with relapsing multiple sclerosis. It aims to assess changes in IgG and IgM concentrations, infection risks, and overall treatment effectiveness over a two-year period. Patients will be monitored for their response to the switch compared to those who continue with anti-CD20 treatments. The study will include patients who have experienced significant infections or declines in IgG levels while on anti-CD20 therapies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with relapsing multiple sclerosis who have been on anti-CD20 therapies for at least 12 months and have experienced significant infection issues or IgG level declines.
Not a fit: Patients with non-relapsing multiple sclerosis or those who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce infection risks and improve treatment outcomes for patients with relapsing multiple sclerosis.
How similar studies have performed: While this approach is novel in the context of switching therapies, similar studies have shown promising results in managing multiple sclerosis with different treatment regimens.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Relapsing MS according to Lublin \[23\] EDSS ≤7.0 - Male and female patients with age \>18 years - Treatment with ocrelizumab or rituximab for ≥12 months and/or having received ≥ 1.2 / 1.0 gr, respectively - For CLAD_GROUP: Planning to switch to cladribine because of concerns about increased risk of infections related to long term anti-CD20 therapies, defined as at least 3 infectious events/year or a serious infection under anti-CD20 and/or a documented decrease of ≥ 5% IgG and/or a level of IgG below 7 gr/L compared to pre- anti-CD20 therapy (will be considered as CLAD_GROUP) - For OCR_GROUP and RTX_GROUP: continuing anti-CD20 therapies (considered as OCR_GROUP and RTX_GROUP with ocrelizumab with rituximab treatment, respectively) - Anti-CD20 and Cladribine are prescribed according to Swiss and European SmPC. Exclusion Criteria: * Non-relapsing MS Pregnancy or lactation - Contraindication to receive cladribine or to continue anti-CD20 therapies according to local label - Inability to complete an MRI - Known presence of other neurological disorders which may mimic MS including but not limited to: neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study - Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study - Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds Infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit - History of progressive multifocal leukoencephalopathy (PML) - Active malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins - History of alcohol or drug abuse within 24 weeks prior to baseline - Lymphocyte count \< 1000 /μL - AST/SGOT or ALT/SGPT ≥ 3.0 Upper Limit of Normal (ULN)
Where this trial is running
Lugano, Ticino
- Ospedale Regionale di Lugano, Istituto di Neuroscienze Cliniche della Svizzera Italiana, Via Tesserete 46, — Lugano, Ticino, Switzerland (Recruiting)
Study contacts
- Study coordinator: Chiara Zecca
- Email: chiara.zecca@eoc.ch
- Phone: +41 91 811 69 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.