Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-29 @ 11:58 AM
Study NCT ID:
NCT06933134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '3 blood samples at months 0, 3, 6, 9 and 12'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed Disease Activity Score(DAS) 28-CRP', 'timeFrame': '6 months after a second low-dose cycle', 'description': 'DAS28-CRP measured by the clinician 6 months after the second cycle of rituximab'}, {'measure': 'Calculated DAS28-CRP', 'timeFrame': '6 months after a second low-dose cycle', 'description': 'DAS28-CRP calculated 6 months after the second cycle of rituximab by a PK-PD model, taking into account gender, body surface area in m2, IgG concentration, rituximab concentration and CD4+ T-cell count'}], 'secondaryOutcomes': [{'measure': 'Prevalence observed DAS28-CRP', 'timeFrame': '3 months and 6 months of the first and second cycle of low-dose rituximab', 'description': '* Percentage of patients with a DAS28-CRP \\< 3.2 at 3 months and 6 months of the first and second cycle of low-dose rituximab\n* Percentage of patients with a DAS28-CRP \\<2.6 at 3 months and 6 months of the first and second cycle of low-dose rituximab'}, {'measure': 'Description of events', 'timeFrame': 'From enrolment to 12 months', 'description': 'Description of moderate and severe infectious events. Description of adverse events occurring during infusions'}, {'measure': 'prevalence calculated DAS28-CRP', 'timeFrame': '6 months of the second cycle of low-dose rituximab', 'description': '* percentage of patients with a predicted DAS 28 CRP \\< 3.2 at 6 months of the second cycle of low-dose rituximab\n* percentage of patients with a predicted DAS 28 CRP \\< 2.6 at 6 months of the second cycle of low-dose rituximab'}, {'measure': 'CD4 T cell count', 'timeFrame': '6 months of a second cycle of low dose rituximab.', 'description': 'T cell count (\\< 500/mm3)'}, {'measure': 'immunoglobulin G level', 'timeFrame': '6 months of a second cycle of low dose rituximab.', 'description': 'immunoglobulin G level (\\< 6 g/L)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacological biomarker', 'rituximab', 'retreatment', 'low dose'], 'conditions': ['Rheumatoid Arthritis (RA)']}, 'descriptionModule': {'briefSummary': 'Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.', 'detailedDescription': 'Rituximab is an anti-CD20 monoclonal antibody which is effective in RA. The dose indicated in the marketing authorisation is 1000 mg twice per cycle. However, rituximab is associated with adverse events, and more specifically the risk of infection, which seems to be dose-dependent. The dose of 1000 mg once a cycle has been evaluated and is non-inferior for maintenance treatment. Lower doses than 1000 mg once could also be sufficient, but there is a lack of predictive criteria to guide clinicians in their search for the minimal effective dose for a given patient.\n\nIn our center, a PK-PD model including several parameters (body surface area, serum IgG concentration, residual rituximab concentrations and CD4+ T-cell count) has enabled to quantify part of the concentration-effect relationship of rituximab in this indication and at standard dose (1000 mg twice at 15-day intervals). On the basis of this model, a model for predicting clinical response has been developed.with reliable prediction of clinical response.\n\nThe aim of this study is to apply this model to patients receiving low-dose rituximab (1000 mg once per cycle) and to evaluate the prediction of clinical response to low-dose rituximab using this model.\n\nCorrelation and coefficient of determination between DAS28-CRP observed 6 months after a second low-dose cycle and DAS-28 predicted by a PK-PD model taking into account gender, body surface area, IgG concentration, rituximab concentration and CD4 T-cell count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria on standard-dose rituximab with a good clinical response.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n. Age ≥ 18 years\n\n* Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.\n* Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.\n* In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.\n* If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.\n\nExclusion Criteria:\n\n* Other associated targeted disease-modifying therapy\n* Sjögren's syndrome or other associated inflammatory rheumatism\n* Fibromyalgia or other pathology having an impact on the assessment of disease activity\n* Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).\n* Opposition to data processing\n* No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.)."}, 'identificationModule': {'nctId': 'NCT06933134', 'acronym': 'PROLOD-RA', 'briefTitle': 'Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'DR230304 - PROLOD-RA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients group', 'description': "The number of subjects required for our study was set at 30. It's a single-centre prospective non-interventional descriptive study. Patients will be followed every 3 months during 12 months. At inclusion, they will receive a first cycle of low-dose rituximab followed by a second cycle at 6 months."}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Simon BRUNET', 'role': 'CONTACT', 'email': 'simon.brunet@chu-tours.fr', 'phone': '247475917', 'phoneExt': '+33'}], 'facility': 'University hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Simon BRUNET', 'role': 'CONTACT', 'email': 'simon.brunet@chu-tours.fr', 'phone': '247475917', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}