Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-31 @ 10:09 AM
Study NCT ID:
NCT04574492
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2020-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis
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': 'ACTUAL', 'count': 413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-09-29', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve Clinical Remission', 'timeFrame': 'At Month 6', 'description': 'Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\\<2.6.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Using Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Pain is defined using VAS, where a higher score indicates worse pain.'}, {'measure': 'Duration of Morning Stiffness', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Duration of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness.'}, {'measure': 'Severity of Morning Stiffness', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Severity of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness.'}, {'measure': 'Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': "The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (0 = not at all fatigued to 4 = very much fatigued)."}, {'measure': 'Percentage of Participants Achieving Clinical Remission', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Clinical Remission is defined as DAS28-CRP\\<2.6, Simplified Disease Activity Index (SDAI) ≤3.3, Clinical Disease Activity Index (CDAI) ≤2.8, American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) Boolean remission.'}, {'measure': 'Percentage of Participants Achieving Low Disease Activity (LDA)', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'LDA is defined as DAS28-CRP\\<3.2, SDAI ≤11, CDAI ≤10.'}, {'measure': 'Earliest Date When a Response to Treatment is Known to Have Occurred', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Earliest date when a response to treatment is known to have occurred.'}, {'measure': 'Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment)', 'timeFrame': 'Through Month 24', 'description': 'Earliest date when their RA is known to have returned (In those participants who achieve a response to treatment).'}, {'measure': 'Change in DAS28-CRP Score', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'The DAS28-CRP used to evaluate disease activity in participants with RA, where worsening RA activity is defined by a higher score.'}, {'measure': 'Change in CDAI Score', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'The CDAI is used to evaluate disease activity in participants with RA , where worsening RA activity is defined by a higher score.'}, {'measure': 'Change in Tender Joint Count', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Change in Tender Joint Count.'}, {'measure': 'Change in Swollen Joint Count', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'Change in Swollen Joint Count.'}, {'measure': 'Change in Physical Function (HAQ-DI) Score', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': 'The HAQ DI is a questionnaire that determines physical function.'}, {'measure': 'Change in Patient Assessment of Global Disease Activity (PtGA)', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': "The PtGA is a outcome instrument to assess the participant's assessment of disease severity."}, {'measure': 'Change in Physician Assessment of Global Disease Activity (PGA)', 'timeFrame': 'Baseline (Month 0) Through Month 24', 'description': "The PGA is a outcome instrument to assess the participant's assessment of disease severity."}, {'measure': 'Percentage of Participants Who Discontinue Upadacitinib', 'timeFrame': 'Through Month 24', 'description': 'Percentage of participants who discontinue Upadacitinib.'}, {'measure': 'Time of Discontinuation from Upadacitinib Initiation Date', 'timeFrame': 'Through Month 24', 'description': 'Time of discontinuation from Upadacitinib initiation date.'}, {'measure': 'Reasons for Upadacitinib Treatment Discontinuation', 'timeFrame': 'Through Month 24', 'description': 'Reasons for Upadacitinib treatment discontinuation.'}, {'measure': 'Immediate Change in RA Medications Following Discontinuation of Upadacitinib', 'timeFrame': 'Through Month 24', 'description': 'Immediate change in RA medications following discontinuation of Upadacitinib.'}, {'measure': 'Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib', 'timeFrame': 'Through Month 24', 'description': 'Clinical remission is defined as DAS28 and CRP\\<2.6.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Upadacitinib', 'RINVOQ'], 'conditions': ['Rheumatoid Arthritis (RA)']}, 'referencesModule': {'references': [{'pmid': '38467912', 'type': 'DERIVED', 'citation': 'Bessette L, Chan J, Chow A, Lisnevskaia L, Richard N, Fournier PA, Liazoghli D, Girard T, Haaland D. Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study. Rheumatol Ther. 2024 Jun;11(3):563-582. doi: 10.1007/s40744-024-00651-8. Epub 2024 Mar 11.'}], 'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P20-096#additional-resources-section', 'label': 'Clinical Study Report Synopsis'}]}, 'descriptionModule': {'briefSummary': 'Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA.\n\nUpadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada.\n\nParticipants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months.\n\nThere will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator.\n* Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study.\n* Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups:\n\n * Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARD).\n * Has not been previously exposed to tsDMARD and has been previously exposed to \\<= 2 bDMARDs.\n * Has been previously treated with one tsDMARD and \\<=1 bDMARD prior to treatment with that tsDMARD.\n\nExclusion Criteria:\n\n* Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the treatment of RA.\n* Diagnosis of rheumatic disease other than RA.\n* Diagnosis of juvenile RA.\n* Currently participating in an investigational clinical trial.\n* Has prior exposure to a bDMARD after exposure to a tsDMARD.\n* Has prior exposure to tsDMARD in an investigational clinical trial."}, 'identificationModule': {'nctId': 'NCT04574492', 'acronym': 'CLOSEUP', 'briefTitle': 'A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Canadian Real-life Post-marketing Observational Study Assessing the Effectiveness of Upadacitinib for Treating Rheumatoid Arthritis (CLOSEUP)', 'orgStudyIdInfo': {'id': 'P20-096'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving Upadacitinib', 'description': 'Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5M 0H4', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Rheumatology Research Associates /ID# 224534', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 0T2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Saurash Reddy Professional Corporation /ID# 225288', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3L 3W4', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Fraser Clinical Trials Inc /ID# 225200', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V5Z 1J9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Jonathan D. Chan Inc. /ID# 222976', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8P 5P6', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Milton F. Baker Inc. /ID# 224555', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R3A 1M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Manitoba Clinic /ID# 223288', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Eastern Regional Health Authority /ID# 223911', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1B 5E8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Nexus Clinical Research /ID# 225896', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B1S 3N1', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Dr. Juris Lazovskis Inc. /ID# 224817', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'L9G 3K9', 'city': 'Ancaster', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536', 'geoPoint': {'lat': 43.21806, 'lon': -79.98716}}, {'zip': 'L6R 0W3', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L7R 2H3', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'N1R 4S1', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Paolo Pace Medicine Professional Corporation /ID# 234057', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'L9H 1B7', 'city': 'Dundas', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814', 'geoPoint': {'lat': 43.27291, 'lon': -79.94216}}, {'zip': 'M9C 5N2', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arthur Karasik Medicine Professional Corporation /ID# 225276', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Adachi Medicine Prof. Corp /ID# 223872', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare /ID# 224042", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L9C 5N2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West Mountain Medical Center /ID# 222975', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L5A 3V8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brandusa Florica Medicine Professional Corporation /ID# 222173', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 2V8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley Rheumatology /ID# 219226', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 4N4', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Imtiaz MS Khan Medicine Prof /ID# 225275', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L2E 6A6', 'city': 'Niagara Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rajwinder S. Dhillon Medicine /ID# 224365', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Makhzoum Medicine Professional Corporation /Id# 229629', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'L6M 1M1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. S. Gill Medicine Professional Corporation /ID# 225238', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'L3V 1T5', 'city': 'Orillia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Waterside Clinic /ID# 224205', 'geoPoint': {'lat': 44.60868, 'lon': -79.42068}}, {'zip': 'L1H 1B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 7X3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Angela Montgomery Medicine Professional Corporation /ID# 231142', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L2N 7E4', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Niagara Peninsula Arthritis Ct /ID# 221472', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'N8X 1T3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Rheumatology Institute of Montreal /ID# 224045', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3T2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Applied Medical Informatics Research Inc. (AMIR) /ID# 224321', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4N 1C6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique de Rhumatologie de Montreal /ID# 221266', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G5L 5T1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSSBSL -Hopital regional de Rimouski /ID# 224681', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'G1V 3M7', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Groupe de Recherche en Maladies Osseuses Inc /ID# 222977', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'zip': 'J1G 2E8', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS de l'Estrie - CHUS /ID# 225404", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'G8Z 1Y2', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Musculo-Squelettique /ID# 224513', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'S7H 5M7', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Dr Naik-Medical Professional Corporation-Alliance Health /ID# 221195', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'S7K 0H6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Rheumatology Associates /ID# 228584', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}