Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 12:56 PM
Study NCT ID:
NCT01101295
Status:
UNKNOWN
Last Update Posted:
2012-03-21
First Post:
2010-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D012713', 'term': 'Serum Sickness'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2010-04-05', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a serious adverse events (clinical or biological events)', 'timeFrame': '5 years', 'description': 'reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...'}], 'secondaryOutcomes': [{'measure': 'Impact of rituximab on the natural history of ITP', 'timeFrame': '5 years', 'description': 'Number of patients in complete response (platelet count\\>100G/L), in partial response (platelet count\\>50G/L and at least doubling the baseline platelet count)or in failure. Rate of diminution for the concomittant therapies for ITP.\n\nUse of emergencies treatment for ITP.'}, {'measure': 'Modality of the administration of rituximab', 'timeFrame': '5 years', 'description': 'number of perfusions, dosage, retreatment.'}, {'measure': 'Characteristics of the patients receiving Rituximab', 'timeFrame': '5 years', 'description': 'age, sex, duration of ITP, previous used treatment'}, {'measure': 'Evaluation of the Platelet count evolution', 'timeFrame': '5 years', 'description': 'Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.'}, {'measure': 'Rate of splenectomy in the cohort', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immune Thrombocytopenia', 'Rituximab', 'side effects', 'tolerance', 'safety', 'splenectomy', 'serum sickness'], 'conditions': ['Purpura, Thrombocytopenic, Idiopathic', 'Autoimmune Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '25293768', 'type': 'DERIVED', 'citation': 'Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrere F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.', 'detailedDescription': "Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.\n\nImmune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ITP diagnosis according to the American Society of Hematology society\n* Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)\n\nExclusion Criteria:\n\n* Previous treatment by rituximab\n* Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)\n* Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)'}, 'identificationModule': {'nctId': 'NCT01101295', 'acronym': 'ITP-RITUX', 'briefTitle': 'The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.', 'orgStudyIdInfo': {'id': 'GECAI'}}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'state': 'Val de Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mehdi KHELLAF, MD', 'role': 'CONTACT', 'email': 'mehdi.khellaf@hmn.aphp.fr', 'phone': '0033149812076'}, {'name': 'Mehdi KHELLAF, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Henri Mondor University Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94010', 'city': 'Créteil', 'state': 'Val de Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mehdi KHELLAF, MD', 'role': 'CONTACT', 'email': 'mehdi.khellaf@hmn.aphp.fr', 'phone': '0033149812076'}], 'facility': 'National Reference Center for the Study of Auto Immune Cytopenia', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Bertrand GODEAU, MD', 'role': 'CONTACT', 'email': 'bertrand.godeau@hmn.aphp.fr', 'phone': '0033149812900'}, {'name': 'Mehdi KHELLAF, MD', 'role': 'CONTACT', 'email': 'mehdi.khellaf@hmn.aphp.fr', 'phone': '0033149812076'}], 'overallOfficials': [{'name': 'Bertrand GODEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Reference Center for Study of Cytopenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Khellaf Mehdi', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}