Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT05621733
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with an AE/ ADR', 'timeFrame': 'Up to 24 weeks', 'description': 'Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided'}, {'measure': 'Proportion of patients with a SAE/ SADR', 'timeFrame': 'Up to 24 weeks', 'description': 'Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided'}, {'measure': 'Proportion of patients with an UAE/ UADR', 'timeFrame': 'Up to 24 weeks', 'description': 'Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided'}, {'measure': 'Proportion of patients with a SUAE/ SUADR', 'timeFrame': 'Up to 24 weeks', 'description': 'Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'Week 4 and Week 24', 'description': 'ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).'}, {'measure': 'Treatment failure rate', 'timeFrame': 'Week 4 and Week 24', 'description': 'Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR.'}, {'measure': 'Death rate', 'timeFrame': 'Week 4 and Week 24', 'description': 'Death rate will be provided'}, {'measure': 'Percentage change in CBC', 'timeFrame': 'Baseline and Week 24', 'description': 'Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided'}]}, 'conditionsModule': {'keywords': ['Graft-versus-Host disease', 'GvHD', 'NIS', 'Korea', 'ruxolitinib', 'Jakavi'], 'conditions': ['Graft-versus-Host Disease']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD) patients', 'detailedDescription': 'The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Jakavi®. All participants who receive at least one dose of the drug and are in the follow-up assessment or early discontinuation (withdrawal) will be the safety population. This study will enroll patients who are newly starting Jakavi® and patients who have been taking Jakavi® prior to study participation. Considering the current clinical practice, a 24 weeks follow-up period of ruxolitinib treatment is needed to assess the safety and the durable effectiveness of the treatment. Mandatory additional safety monitoring will be conducted following the last dose of the treatment for further AE assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label\n2. Patients who are willing to provide written informed consent prior to study enrollment\n\nExclusion Criteria:\n\n1. Patients under 12 years old\n2. Patients with contraindication according to locally approved label of Jakavi®\n3. Patients who receive or are going to receive any investigational medicine during the observation period.'}, 'identificationModule': {'nctId': 'NCT05621733', 'briefTitle': 'A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Post Marketing Surveillance of Jakavi® (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea', 'orgStudyIdInfo': {'id': 'CINC424C2415'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ruxolitinib', 'description': 'Patients currently receiving or going to receive Jakavi® treatment according to locally approved label', 'interventionNames': ['Other: ruxolitinib']}], 'interventions': [{'name': 'ruxolitinib', 'type': 'OTHER', 'otherNames': ['Jakavi'], 'description': 'Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.', 'armGroupLabels': ['ruxolitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42602', 'city': 'Daegu', 'state': 'Dalseo gu', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho gu', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '48108', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-030', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '519763', 'city': 'Jeollanam', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'zip': '660-702', 'city': 'Jinju', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41944', 'city': 'Taegu', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.88889, 'lon': 128.07278}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}