MS patients may benefit from switching Immune-Suppressing drugs
NCT ID NCT06854094
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether switching from anti-CD20 drugs (like ocrelizumab) to cladribine can help restore immune function and reduce infections in people with relapsing multiple sclerosis. About 70 participants will be followed for 2 years. The goal is to see if the switch improves antibody levels and lowers infection risk compared to staying on anti-CD20 therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cladribine
- What this could lead to
- If successful, this could show that switching to cladribine helps restore immune function and lowers infection risk for MS patients on long-term anti-CD20 therapy.
- What could go wrong
- This is a relatively small study (70 people) and results may not apply to all MS patients. The switch might not improve immunity or could cause other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The recruited population will consist in 70 patients with RMS treated with anti-CD20 (ocrelizumab or rituximab) for ≥12 months and/or having received 1.2/1.0 gr, respectively, of the previously mentioned drugs that are switched to cladribine because of concerns about increased risks of infections during long term anti-CD20 therapies (defined as at least 3 infectious events/year and/or a serious infection under anti-CD20 treatment and/or a documented decrease of ≥ 5% IgG compared to pre anti-CD20 therapy and/or a level of IgG below 7 gr/L (CLAD\_GROUP)).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ospedale Regionale di Lugano, Istituto di Neuroscienze Cliniche della Svizzera Italiana, Via Tesserete 46,
Lugano, Canton Ticino, 6903, Switzerland
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