Multiple SclerosisOCR_CLADNCT06854094
Consolidation Therapy With Cladribine in Relapsing Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
To investigate the impact on IgG and IgM concentration, infection risk and effectiveness of switching from anti-CD20 to cladribine compared to continued anti-CD20 treatment over 2 years in relapsing MS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Oct 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)).
Who may be able to join
- 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 CLADGROUP: 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 CLADGROUP)
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Lugano, Istituto di Neuroscienze Cliniche della Svizzera Italiana, Via Tesserete 46,
Lugano, Canton Ticino, 6903
About this study
Official title: Consolidation Therapy With Immune Reconstitution Therapy (Cladribine) in Relapsing Multiple Sclerosis Patients Following a Treatment With Anti-CD20 Compounds: a Pivotal Study
To investigate the impact on IgG and IgM concentration, infection risk and effectiveness of switching from anti-CD20 to cladribine compared to continued anti-CD20 treatment over 2 years in relapsing MS patients.
- Conditions
- Multiple Sclerosis
- Keywords
- Switch to Cladribine
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in IgG serum concentrations 6, 12, 24 months after switching to cladribine following a treatment with anti-CD20 therapies compared to the last 12 months of antiCD20 therapy, and to patients continuing anti-CD20.
- Explore the impact of switching from continuous anti-CD20 to cladribine on serum immunoglobulins and other clinical, imaging and biomarker parameters in a large, multicenter, international population of MS patients
- Extend the observation period to at least 2 years in order to see a stabilization or an improvement of immunoglobulin concentration and a related decreased infection rate in patients switching to cladribine compared to those continuing anti-CD20.
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start3 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Collaborators
- 3B Biotech Research
- Responsible party
- Principal investigator, Chiara Zecca, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854094
- Sponsor's protocol ID
- OCR_CLAD INSI.SM.2403
- Acronym
- OCR_CLAD
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation Therapy With Immune Reconstitution Therapy (Cladribine) in Relapsing Multiple Sclerosis Patients Following a Treatment With Anti-CD20 Compounds: a Pivotal Study
- ClinicalTrials.gov ID
- NCT06854094
- Acronym / sponsor ID
- OCR_CLAD / OCR_CLAD INSI.SM.2403
- Conditions
- Multiple Sclerosis
- Keywords
- Switch to Cladribine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Collaborators
- 3B Biotech Research
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the impact on IgG and IgM concentration, infection risk and effectiveness of switching from anti-CD20 to cladribine compared to continued anti-CD20 treatment over 2 years in relapsing MS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)).
Key inclusion criteria (4 listed)
- 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 CLADGROUP: 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 CLADGROUP)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in IgG serum concentrations 6, 12, 24 months after switching to cladribine following a treatment with anti-CD20 therapies compared to the last 12 months of antiCD20 therapy, and to patients continuing anti-CD20.
Time frame: From enrollment to the end of treatment at 24 months
1. Explore the impact of switching from continuous anti-CD20 to cladribine on serum immunoglobulins and other clinical, imaging and biomarker parameters in a large, multicenter, international population of MS patients 2. Extend the observation period to at least 2 years in order to see a stabilization or an improvement of immunoglobulin concentration and a related decreased infection rate in patients switching to cladribine compared to those continuing anti-CD20.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in IgG serum concentrations 6, 12, 24 months after switching to cladribine following a treatment with anti-CD20 therapies compared to the last 12 months of antiCD20 therapy, and to patients continuing anti-CD20. (time frame: From enrollment to the end of treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.