Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04640818
Status:
UNKNOWN
Last Update Posted:
2022-03-23
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C533411', 'term': 'ocrelizumab'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency of infections', 'timeFrame': '6 months', 'description': 'Safety endpoint'}, {'measure': 'Frequency of infections', 'timeFrame': '12 months', 'description': 'Safety endpoint'}, {'measure': 'Intensity of infections', 'timeFrame': '6 months', 'description': "Safety endpoint, intensity will be rated according to the following definitions:\n\nMild: 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.\n\nSerious: 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."}, {'measure': 'Intensity of infections', 'timeFrame': '12 months', 'description': "Safety endpoint, intensity will be rated according to the following definitions:\n\nMild: 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.\n\nSerious: 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."}, {'measure': 'Proportion of patients with abnormal creatinine values of clinical relevance', 'timeFrame': '6 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with abnormal creatinine values of clinical relevance', 'timeFrame': '12 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with abnormal ASAT values of clinical relevance', 'timeFrame': '6 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with abnormal ASAT values of clinical relevance', 'timeFrame': '12 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with abnormal ALAT values of clinical relevance', 'timeFrame': '6 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with abnormal ALAT values of clinical relevance', 'timeFrame': '12 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with any abnormal hematology values of clinical relevance', 'timeFrame': '6 months', 'description': 'Safety endpoint'}, {'measure': 'Proportion of patients with any abnormal hematology values of clinical relevance', 'timeFrame': '12 months', 'description': 'Safety endpoint'}], 'primaryOutcomes': [{'measure': 'Changes in IgG serum concentrations in Cald-Group', 'timeFrame': '6 months', 'description': 'Standard laboratory test'}, {'measure': 'Changes in IgM serum concentrations in Cald-Group', 'timeFrame': '6 months', 'description': 'Standard laboratory test'}, {'measure': 'Changes in IgG serum concentrations in Clad-Group', 'timeFrame': '12 months', 'description': 'Standard laboratory test'}, {'measure': 'Changes in IgM serum concentrations in Clad-Group', 'timeFrame': '12 months', 'description': 'Standard laboratory test'}], 'secondaryOutcomes': [{'measure': 'Changes in IgG serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies', 'timeFrame': '6 months', 'description': 'Standard laboratory test'}, {'measure': 'Changes in IgM serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies', 'timeFrame': '6 months', 'description': 'Standard laboratory test'}, {'measure': 'Changes in IgG serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies', 'timeFrame': '12 months', 'description': 'Standard laboratory test'}, {'measure': 'Changes in IgM serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies', 'timeFrame': '12 months', 'description': 'Standard laboratory test'}, {'measure': 'Proportion of patients reaching NEDA -3', 'timeFrame': '12 months', 'description': 'NEDA -3: no relapses, no disability progression, no new/enlarging or Gd enhancing brain or spinal MR lesions'}, {'measure': 'Annualized relapse rate (ARR) over 12 months after switching to cladribine as compared to patients continuing anti CD20 therapies', 'timeFrame': '12 months', 'description': 'ARR will be calculated based on recorded number of relapses'}, {'measure': 'Proportion of patients with disability progression', 'timeFrame': '6 months', 'description': 'Expanded disability scale 0-6 (6 worst outcome)'}, {'measure': 'Proportion of patients with disability progression', 'timeFrame': '12 months', 'description': 'Expanded disability scale 0-6 (6 worst outcome)'}, {'measure': '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', 'timeFrame': '12 months', 'description': 'Evaluation of MRI'}, {'measure': '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', 'timeFrame': '12 months', 'description': 'Evaluation of MRI'}, {'measure': 'Changes in serum neurofilament light chain concentration', 'timeFrame': '12 months', 'description': 'single-molecule array (Simoa) assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti CD20 therapy', 'cladribine'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Prolonged anti CD20 therapy for the treatment of active multiple sclerosis leading to continuous B cell depletion is associated with hypogammaglobulinemia predisposing to a potentially increased risk of serious infections, particularly in the more disabled and aged patients. No data have been published on the sequential use of anti CD20 therapies and cladribine, that is thought to act as an immune reconstitution agent. his study aims at investigating IgG and IgM serum concentration changes at 6 and 12 months after switching to cladribine in patients previously treated with anti CD20 therapies (ie, ocrelizumab ≥1.8 gr or rituximab 3.0 gr) for ≥18 months, as compared to continued anti CD20 therapies.', 'detailedDescription': 'The study population will include patients with remitting relapsing multiple sclerosis consulting the Multiple Sclerosis Center of Neurocenter of Southern Switzerland.\n\nEnrolled 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsing multiple sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsing MS according to Lublin;\n* Treatment with ocrelizumab or rituximab for ≥18 months and having received 1.8 / 3.0 gr, respectively;\n* 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;\n* 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;\n* EDSS ≤7.0;\n* Age \\>18 years.\n\nExclusion Criteria:\n\n* Non relapsing MS;\n* Pregnancy - breastfeeding;\n* Contraindications to perform MRI;\n* Contraindication to receive cladribine or to continue anti CD therapies'}, 'identificationModule': {'nctId': 'NCT04640818', 'briefTitle': 'Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ospedale Civico, Lugano'}, 'officialTitle': 'Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study', 'orgStudyIdInfo': {'id': 'EOCNSIMS.2001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CLAD-GROUP', 'description': 'Patients with cladribine therapy', 'interventionNames': ['Drug: Cladribine Oral Tablet']}, {'label': 'CD20-GROUP', 'description': 'Patients with anti CD20 therapy (ocrelizumab or rituximab)', 'interventionNames': ['Drug: Rituximab', 'Drug: Ocrelizumab']}], 'interventions': [{'name': 'Cladribine Oral Tablet', 'type': 'DRUG', 'otherNames': ['Mavenclade'], 'description': 'Treatment according to the label and medical prescription', 'armGroupLabels': ['CLAD-GROUP']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera, Rixathon'], 'description': 'Treatment according to the label and medical prescription', 'armGroupLabels': ['CD20-GROUP']}, {'name': 'Ocrelizumab', 'type': 'DRUG', 'otherNames': ['Ocrevus'], 'description': 'Treatment according to the label and medical prescription', 'armGroupLabels': ['CD20-GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6903', 'city': 'Lugano', 'state': 'Canton Ticino', 'country': 'Switzerland', 'facility': 'Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Claudio Gobbi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Regionale di Lugano, Neurocentro della Svizzera italiana, Centro Sclerosi multipla'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claudio Gobbi', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Merck AG Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Physician', 'investigatorFullName': 'Claudio Gobbi', 'investigatorAffiliation': 'Ospedale Civico, Lugano'}}}}