- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04640818
Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy
Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study population will include patients with remitting relapsing multiple sclerosis consulting the Multiple Sclerosis Center of Neurocenter of Southern Switzerland.
Enrolled patients will have 5 Study Visits, one every 3 months according to clinical practice. At visits at 3 and 6 months only adverse events will be collected for study purposes. Clinical assessments will be performed at baseline, Month 6 and Month 12. Clinical assessments correspond to medical exams performed routinely in MS patients treated with anti CD20 or cladribine therapy: clinical assessments, monitoring haemoglobin parameters, serum immunoglobulins, liver and renal function.(6, 12 months), radiological disability progression and biomarker of ongoing neurodegeneration (12 months).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ticino
-
Lugano, Ticino, Switzerland, 6903
- Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Relapsing MS according to Lublin;
- Treatment with ocrelizumab or rituximab for ≥18 months and having received 1.8 / 3.0 gr, respectively;
- CLAD_GROUP: Planning to switch to cladribine because of concerns about increased risks of infections related to hypogammaglobulinemia developing during long term anti CD20 therapies or a documented decrease of ≥10% IgG and/or IgM compared to pre- anti CD20 therapy;
- or CD20_GROUP: no need to stop CD20 therapy due decrease of ≥10% IgG and/or IgM, or increased risk of infections related to hypogammaglobulinemia or other reasons, continued anti CD20 therapies clinically indicated;
- EDSS ≤7.0;
- Age >18 years.
Exclusion Criteria:
- Non relapsing MS;
- Pregnancy - breastfeeding;
- Contraindications to perform MRI;
- Contraindication to receive cladribine or to continue anti CD therapies
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CLAD-GROUP
Patients with cladribine therapy
|
Treatment according to the label and medical prescription
Other Names:
|
CD20-GROUP
Patients with anti CD20 therapy (ocrelizumab or rituximab)
|
Treatment according to the label and medical prescription
Other Names:
Treatment according to the label and medical prescription
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in IgG serum concentrations in Cald-Group
Time Frame: 6 months
|
Standard laboratory test
|
6 months
|
Changes in IgM serum concentrations in Cald-Group
Time Frame: 6 months
|
Standard laboratory test
|
6 months
|
Changes in IgG serum concentrations in Clad-Group
Time Frame: 12 months
|
Standard laboratory test
|
12 months
|
Changes in IgM serum concentrations in Clad-Group
Time Frame: 12 months
|
Standard laboratory test
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in IgG serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Time Frame: 6 months
|
Standard laboratory test
|
6 months
|
Changes in IgM serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Time Frame: 6 months
|
Standard laboratory test
|
6 months
|
Changes in IgG serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Time Frame: 12 months
|
Standard laboratory test
|
12 months
|
Changes in IgM serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Time Frame: 12 months
|
Standard laboratory test
|
12 months
|
Proportion of patients reaching NEDA -3
Time Frame: 12 months
|
NEDA -3: no relapses, no disability progression, no new/enlarging or Gd enhancing brain or spinal MR lesions
|
12 months
|
Annualized relapse rate (ARR) over 12 months after switching to cladribine as compared to patients continuing anti CD20 therapies
Time Frame: 12 months
|
ARR will be calculated based on recorded number of relapses
|
12 months
|
Proportion of patients with disability progression
Time Frame: 6 months
|
Expanded disability scale 0-6 (6 worst outcome)
|
6 months
|
Proportion of patients with disability progression
Time Frame: 12 months
|
Expanded disability scale 0-6 (6 worst outcome)
|
12 months
|
Number/volume of cumulative new T2/ enlarging lesions at brain and spinal MRI over 12 months after switching to cladribine, as compared to patients continuing anti CD20 therapies
Time Frame: 12 months
|
Evaluation of MRI
|
12 months
|
Number/volume of cumulative Gd enhancing lesions at brain and spinal MRI over 12 months after switching to cladribine, as compared to patients continuing anti CD20 therapies
Time Frame: 12 months
|
Evaluation of MRI
|
12 months
|
Changes in serum neurofilament light chain concentration
Time Frame: 12 months
|
single-molecule array (Simoa) assay
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of infections
Time Frame: 6 months
|
Safety endpoint
|
6 months
|
Frequency of infections
Time Frame: 12 months
|
Safety endpoint
|
12 months
|
Intensity of infections
Time Frame: 6 months
|
Safety endpoint, intensity will be rated according to the following definitions: Mild: Awareness of a sign or symptom that does not interfere with the study participant's usual activity or is transient, resolved without treatment and with no sequelae; Moderate: Interferes with the study participant's usual activity and/or requires symptomatic treatment; Severe: Symptom(s) causing severe discomfort and significant impact of the study participant's usual activity and requires treatment. Serious: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, or is otherwise considered as medically important. |
6 months
|
Intensity of infections
Time Frame: 12 months
|
Safety endpoint, intensity will be rated according to the following definitions: Mild: Awareness of a sign or symptom that does not interfere with the study participant's usual activity or is transient, resolved without treatment and with no sequelae; Moderate: Interferes with the study participant's usual activity and/or requires symptomatic treatment; Severe: Symptom(s) causing severe discomfort and significant impact of the study participant's usual activity and requires treatment. Serious: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, or is otherwise considered as medically important. |
12 months
|
Proportion of patients with abnormal creatinine values of clinical relevance
Time Frame: 6 months
|
Safety endpoint
|
6 months
|
Proportion of patients with abnormal creatinine values of clinical relevance
Time Frame: 12 months
|
Safety endpoint
|
12 months
|
Proportion of patients with abnormal ASAT values of clinical relevance
Time Frame: 6 months
|
Safety endpoint
|
6 months
|
Proportion of patients with abnormal ASAT values of clinical relevance
Time Frame: 12 months
|
Safety endpoint
|
12 months
|
Proportion of patients with abnormal ALAT values of clinical relevance
Time Frame: 6 months
|
Safety endpoint
|
6 months
|
Proportion of patients with abnormal ALAT values of clinical relevance
Time Frame: 12 months
|
Safety endpoint
|
12 months
|
Proportion of patients with any abnormal hematology values of clinical relevance
Time Frame: 6 months
|
Safety endpoint
|
6 months
|
Proportion of patients with any abnormal hematology values of clinical relevance
Time Frame: 12 months
|
Safety endpoint
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claudio Gobbi, MD, Ospedale Regionale di Lugano, Neurocentro della Svizzera italiana, Centro Sclerosi multipla
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Ocrelizumab
- Cladribine
Other Study ID Numbers
- EOCNSIMS.2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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