Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06992505
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Macrophage Activation syndromE in STill's Disease in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055501', 'term': 'Macrophage Activation Syndrome'}, {'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D016706', 'term': "Still's Disease, Adult-Onset"}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D001172', 'term': 'Arthritis, Rheumatoid'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'from 2012 to 2022 (data abdstraction period)', 'description': 'defined as the survival time of patients from the index date'}, {'measure': 'Time to laboratory value normalization', 'timeFrame': 'up to 24 weeks', 'description': 'defined as the time to normalization for key laboratory values'}, {'measure': 'Time to MAS laboratory remission', 'timeFrame': 'up to 24 weeks', 'description': 'defined as the time from index date to the last date of normalization of key laboratory assessments'}, {'measure': 'Time to partial MAS laboratory remission', 'timeFrame': 'up to 24 weeks', 'description': 'defined as the time from index date to the last date of normalization of at least 3 of the key laboratory assessments'}, {'measure': 'Time to tapering of GCs', 'timeFrame': 'from index date to the last of 7 consecutive days receiving ≤1 mg/kg/day of prednisone (PDN) equivalent dose', 'description': 'defined as the time from index date to the last of 7 consecutive days receiving ≤1 mg/kg/day of prednisone (PDN) equivalent dose'}, {'measure': 'Number of recurrent MAS episodes', 'timeFrame': 'from hospital discharge or 26-weeks from the index date, whichever occurs later, until the end of study data collection]', 'description': 'defined as the number of MAS episodes occurring any time after the end of the data collection period for the index MAS episode (hospital discharge or 26-weeks from the index date, whichever occurs later) until the end of study data collection'}, {'measure': 'Administration of organ support care', 'timeFrame': 'from the index date until either the hospital discharge or 26 weeks, whichever occurs later', 'description': 'defined as the proportion of patients receiving hemodialysis, assisted ventilation, cardiac support, or inotropic drugs at any time from the index date until either the hospital discharge or 26 weeks, whichever occurs later'}, {'measure': 'Characteristics of MAS treatment', 'timeFrame': 'up to 24 weeks', 'description': 'Concomitant medications'}, {'measure': 'Clinical signs', 'timeFrame': 'at index date and 8 weeks after index date (allowed time window 6 to 12 weeks)', 'description': 'Patients experiencing MAS symptoms if present (documentation in free text)'}], 'secondaryOutcomes': [{'measure': 'Time to hospital discharge', 'timeFrame': 'up to 24 weeks', 'description': 'defined as time from the index date to discharge from the hospital'}, {'measure': 'Time to intensive care unit (ICU) discharge', 'timeFrame': 'up to 24 weeks', 'description': 'defined as time from index date to ICU discharge'}, {'measure': 'Normalization of key laboratory values', 'timeFrame': 'Week 8 after index date (allowed time window 6 to 12 weeks)', 'description': 'Normalization of key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks)'}, {'measure': 'MAS laboratory remission', 'timeFrame': 'at Week 8 after index date (allowed time window 6 to 12 weeks).', 'description': 'Normalization of Key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks).'}, {'measure': 'Partial MAS laboratory remission', 'timeFrame': 'at Week 8 after index date (allowed time window 6 to 12 weeks)', 'description': 'Normalization of at least 3 key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks)'}, {'measure': 'Duration of Clinical Response', 'timeFrame': 'up to 24 weeks', 'description': "defined as the time (in days) from the date of first documented MAS laboratory remission until the date of first documented occurrence of a new MAS episode as per Investigator's assessment."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macrophage Activation Syndrome (MAS)', 'Still Disease, Juvenile Onset', "Still's Disease, Adult-Onset"]}, 'descriptionModule': {'briefSummary': "Assessment of macrophage activation syndrome in Still's disease:\n\nretrospective chart analysis of patient history, symptom resolution and treatment characteristics in Italy", 'detailedDescription': "This is an observational, retrospective cohort study on the treatment utilization and outcomes of Macrophage Activation Syndrome (MAS) refractory to glucocorticoids (GC) in patients with Still's disease. The study will be conducted entirely through medical chart abstraction; all data will be taken from the patient's medical record, with no additional assessments. The study will be conducted in Italy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study population will include patients with Still's disease who were diagnosed with MAS that was refractory to GC treatment.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>6 months and ≤80 years at the beginning of the index MAS episode.\n* Diagnosis of Still's disease (sJIA or AOSD diagnosis).\n* Diagnosis of MAS according to treating physician in the medical record.\n* Patients who have received at least 3 consecutive days of GC after diagnosis of MAS and/or are judged by the Investigator to be refractory to GC due to clinical worsening of patient's condition.\n* The onset of the index MAS episode occurred between 01 January 2012 and 30 September 2022.\n* According to local regulations, waivers of consent will be sought for study participants from the appropriate regulatory authorities and/or the independent ethics committee (IEC)/institutional review board (IRB). o For patients not covered by waivers of consent, signed, and dated informed consent provided by the patient, or the patient's legally authorized representative(s) for patients under the legal age (with patient assent, as applicable) or who have died, should be obtained before any study-related activities are undertaken.\n\nExclusion Criteria:\n\n* A diagnosis of primary HLH prior to the beginning of the index MAS episode.\n* Confirmed malignancy prior to the beginning of the index MAS episode.\n* Patient treated with any investigational product as a part of clinical trial during the index MAS episode."}, 'identificationModule': {'nctId': 'NCT06992505', 'acronym': 'AMETISTA', 'briefTitle': "Assessment of Macrophage Activation syndromE in STill's Disease in Italy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': "Assessment of Macrophage Activation syndromE in STill's Disease: Retrospective Chart Analysis of Patient hIstory, Symptom Resolution and TreAtment Characteristics in Italy (AMETISTA)", 'orgStudyIdInfo': {'id': 'Sobi.EMAPALUMAB-106'}}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00165', 'city': 'Rome', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambin Gesù', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Study Physician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Swedish Orphan Biovitrum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}