Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-31 @ 1:16 PM
Study NCT ID:
NCT05544292
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2022-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma and whole blood samples are collected at baseline and after 3 months'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swollen joint count', 'timeFrame': '1 year follow-up', 'description': 'Numbers (0-66)'}], 'secondaryOutcomes': [{'measure': 'C reactive protein', 'timeFrame': '1 year', 'description': 'mg/L'}, {'measure': 'Proportion of pateints with arthritis after one year', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arthritis', 'check point inhibitor', 'irAE'], 'conditions': ['Immune-related Adverse Event']}, 'descriptionModule': {'briefSummary': 'RIMRA is a prospective, longitudinal, observational study including patients with de novo symptoms of rheumatic disease or a flare of established rheumatic disease after treatment with an immune check point inhibitor. The aim of the study is to describe the clinical presentation, disease course and outcome of rheumatic irAEs in patients treated with immune check point inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred with symptoms of a rheumatic condition after cancer treatment with a check point inhibitor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* De novo symptoms of rheumatic disease or a flare of established rheumatic disease after \\>/= 1 dose of treatment with an immune check point inhibitor\n* Adult patients (\\> 18 years)\n* Subject capable of understanding and signing an informed consent form\n\nExclusion Criteria:\n\n• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult'}, 'identificationModule': {'nctId': 'NCT05544292', 'acronym': 'RIMRA', 'briefTitle': 'Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Diakonhjemmet Hospital'}, 'officialTitle': 'Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors - a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'DS 00469'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antiinflammatory/DMARDs', 'type': 'OTHER', 'description': 'Antiinflammatory/DMARDs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ålesund', 'country': 'Norway', 'facility': 'Ålesund Hospital', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Hospital of Southern Norway Trust', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}, {'city': 'Levanger', 'country': 'Norway', 'facility': 'Levanger Hospital', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Diakonhjemmet Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Marte S Heiberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diakonhjemmet Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Alesund Hospital', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Hospital of Southern Norway Trust', 'class': 'OTHER'}, {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}