Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT06712628
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 678}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention Rate of UPA vs TNFi', 'timeFrame': 'Up to approximately 24 months', 'description': 'Time to the discontinuation of Upadacitinib. Time to the discontinuation of Tumor Necrosis Factor Inhibitor treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate to Severe Rheumatoid Arthritis', 'Rheumatoid Arthritis', 'Upadacitinib', 'Tumor Necrosis Factor Inhibitor Treatment'], 'conditions': ['Moderate to Severe Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P25-188', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the retention rates for UPA vs. TNFi treatment in adult participants with moderate to severe active RA per local label and according to local standard of care\n\nThis is a mono-country, prospective, multi-center observational study in patients with moderate to severe active RA receiving UPA or TNFi therapy. Around 678 participants will be enrolled in approximately 80 sites in Germany.\n\nStudy recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with moderate to severe active Rheumatoid Arthritis receiving Upadcitinib or a Tumor necrosis factor inhibitor treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current or Past participants with a confirmed diagnosis of moderate to severe active RA upon judgement of the treating physician.\n* Physician decision on participant treatment with Upadacitinib (UPA) or tumor necrosis factor inhibitor (TNFi) must have been reached prior to and independently of recruitment in the study\n* UPA or TNFi prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies\n\nExclusion Criteria:\n\n* Participation in a clinical trial with an investigational drug (within a minimum of 30 days or 5 half-lives of the investigational drug \\[whichever is longer\\] prior to baseline)\n* Prior treatment with Upadacitinib\n* Prior treatment with the same tumor necrosis factor inhibitor as the one prescribed for this study'}, 'identificationModule': {'nctId': 'NCT06712628', 'acronym': 'UP-RISING', 'briefTitle': 'A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Comparison of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING', 'orgStudyIdInfo': {'id': 'P25-188'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Upadacitinib', 'description': 'Participants will receive upadacitinib as prescribed by their physician according to local label.'}, {'label': 'Tumor Necrosis Factor Inhibitor-Treatment', 'description': 'Participants will receive a tumor necrosis factor inhibitor treatment as prescribed by their physician according to local label.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79098', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Innere Medizin/Rheumatologie /ID# 278584', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Heidelberg /ID# 276475', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '72072', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Haas Tübingen /ID# 275536', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89073', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Ulm Dr. med. Nadia Rinaldi /ID# 276293', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '92224', 'city': 'Amberg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dr. Med. Thomas Marycz /ID# 274646', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '86157', 'city': 'Augsburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Am Webereck /ID# 274412', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '95615', 'city': 'Marktredwitz', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dr. Harmuth /ID# 273401', 'geoPoint': {'lat': 50.00443, 'lon': 12.08593}}, {'zip': '81541', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxiszentrum Dr. Med. Klaus Krüger Dres. Günther Kellerer Und Paul Kellerer /ID# 276138', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '82152', 'city': 'Planegg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 274587', 'geoPoint': {'lat': 48.10672, 'lon': 11.42483}}, {'zip': '16540', 'city': 'Hohen Neuendorf', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Dirk Wernicke /ID# 276820', 'geoPoint': {'lat': 52.67631, 'lon': 13.27775}}, {'zip': '15366', 'city': 'Hoppegarten', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis K. Pagel /ID# 279121', 'geoPoint': {'lat': 52.51667, 'lon': 13.66667}}, {'zip': '14467', 'city': 'Potsdam', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumahaus Studien GbR /ID# 275917', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '17268', 'city': 'Templin', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumatologisch Immunologisch /ID# 275830', 'geoPoint': {'lat': 53.11865, 'lon': 13.5022}}, {'zip': '35080', 'city': 'Bad Endenbach', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumatism Center Mittelhessen /ID# 274641'}, {'zip': '60329', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 274291', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '30161', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Hannover-List /ID# 273735', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30173', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis. F. Bigdeli-Wilshusen /ID# 273455', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '34125', 'city': 'Kassel', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumatologie Kassel /ID# 275916'}, {'zip': '49074', 'city': 'Osnabrück', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis An Der Hase /ID# 276949', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '28844', 'city': 'Weyhe', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Fachpraxis für Rheumatologie und Osteologie /ID# 275359', 'geoPoint': {'lat': 52.96667, 'lon': 8.66667}}, {'zip': '17033', 'city': 'Neubrandenburg', 'state': 'Mecklenburg-Vorpommern', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Thilo Klopsch - Stargarder Strasse /ID# 276367', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}, {'zip': '44649', 'city': 'Herne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumazentrum Ruhrgebiet /ID# 275518', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '40668', 'city': 'Meerbusch', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'St.Elisabeth Hospital Meerbusch /ID# 275030', 'geoPoint': {'lat': 51.25268, 'lon': 6.68807}}, {'zip': '40882', 'city': 'Ratingen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumazentrum Ratingen /ID# 275707', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'zip': '67657', 'city': 'Kaiserslautern', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis Dr. med. Florian Beyer /ID# 274293', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'zip': '66424', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis am Schlossberg /ID# 272728', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '66538', 'city': 'Neunkirchen', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dr. Murawski /ID# 272724', 'geoPoint': {'lat': 49.34449, 'lon': 7.18045}}, {'zip': '66346', 'city': 'Püttlingen', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Knappschaftsklinikum Saar /ID# 279852', 'geoPoint': {'lat': 49.2855, 'lon': 6.88723}}, {'zip': '66346', 'city': 'Püttlingen', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Dr. Prothmann /ID# 279851', 'geoPoint': {'lat': 49.2855, 'lon': 6.88723}}, {'zip': '09130', 'city': 'Chemnitz', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Medizinischen Versorgungszentrums Agilomed /ID# 274887', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '09599', 'city': 'Freiberg', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dr. Mueller /ID# 273081', 'geoPoint': {'lat': 50.91089, 'lon': 13.33881}}, {'zip': '04109', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Frank Hamann, Dr. Andreas Teich & Dr. Konrad Boche /ID# 275358', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04129', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Ilka Schwarze /ID# 276981', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '08523', 'city': 'Plauen', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Christine Baumann /ID# 275095', 'geoPoint': {'lat': 50.4973, 'lon': 12.13782}}, {'zip': '08056', 'city': 'Zwickau', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis H. Fricke-Wagner /ID# 274467', 'geoPoint': {'lat': 50.72724, 'lon': 12.48839}}, {'zip': '06128', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Dr. Liebhaber /ID# 274888', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '39104', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumatologische Facharztpraxis /ID# 272866', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '24768', 'city': 'Rendsburg', 'state': 'Schleswig-Holstein', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Jochen Walter /ID# 280069', 'geoPoint': {'lat': 54.30182, 'lon': 9.67175}}, {'zip': '04600', 'city': 'Altenburg', 'state': 'Thuringia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Thomas Kupka /ID# 273631', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'zip': '99427', 'city': 'Weimar', 'state': 'Thuringia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Weimar /ID# 272740', 'geoPoint': {'lat': 50.9803, 'lon': 11.32903}}, {'zip': '31812', 'city': 'Bad Pyrmont', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'MVZ Weserbergland /ID# 276009', 'geoPoint': {'lat': 51.98589, 'lon': 9.25246}}, {'zip': '13055', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Silke Zinke /ID# 276366', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '38114', 'city': 'Braunschweig', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'MVZ Herzogin Elisabeth Hospital /ID# 272725', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '96450', 'city': 'Coburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Sebastian Schuh /ID# 272731', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '52355', 'city': 'Düren', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumapraxis Düren /ID# 272726', 'geoPoint': {'lat': 50.80434, 'lon': 6.49299}}, {'zip': '35630', 'city': 'Ehringshausen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis Dilltal /ID# 272727', 'geoPoint': {'lat': 50.6, 'lon': 8.38333}}, {'zip': '99096', 'city': 'Erfurt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Daniel Bestler /ID# 272741', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '17493', 'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis Fiene /ID# 279410', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '22391', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Hauke E. Heintz /ID# 278081', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '06618', 'city': 'Naumburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumatologische Facharztpraxis /ID# 272743', 'geoPoint': {'lat': 51.14987, 'lon': 11.80979}}, {'zip': '42105', 'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Cellitinnen-Krankenhaus St. Josef /ID# 275926', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '42285', 'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis Barmen /ID# 277514', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'centralContacts': [{'name': 'Medical Information Germany', 'role': 'CONTACT', 'email': 'medinfo.germany@abbvie.com', 'phone': '49 611 1720 1520'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}