Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT01387802
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2011-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 722}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2011-07-01', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))'}, {'measure': 'Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))'}, {'measure': 'Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))'}, {'measure': 'Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))'}], 'secondaryOutcomes': [{'measure': 'BASFI (Bath AS Functional Assay)', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations'}, {'measure': 'PASQ (Psoriasis and Arthritis Screening Questionnaire)', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'This is an 11 item tool that ascertains self reported presence of joint pain and swelling.'}, {'measure': 'BASDAI (Bath AS Disease Activity Index)', 'timeFrame': 'Every 3 months up to 6 months, then every 6 months up to 24 months', 'description': 'This is a 100 VAS with 0 indicating lowest disease activity and 10 highest disease activity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Assessing Effectiveness in Ankylosing Spondylitis'], 'conditions': ['Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'The current study will assess the real - life effectiveness of adalimumab in the management of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular manifestations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Offices of community rheumatologists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult \\>= 18 years old\n* Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel\n* Active Ankylosing Spondylitis as per the judgment of the treating physician\n* Inadequate response or non tolerant to current NSAID (Nonsteroidal Anti-Inflammatory Drug) or DMARD (Disease-Modifying Anti Rheumatic Drug) based treatment for AS\n\nExclusion Criteria:\n\n* Currently participating in another prospective study including controlled clinical trials and observational studies\n* Patient cannot or will not sign informed consent\n* Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated\n* Previous treatment with anti-TNF (Tumor Necrosis Factor) or other biologic agent\n* Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of AS'}, 'identificationModule': {'nctId': 'NCT01387802', 'acronym': 'Complete-AS', 'briefTitle': 'Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)', 'orgStudyIdInfo': {'id': 'P12-672'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Biologic arm', 'description': 'Patients that have not responded to the current treatment with an NSAID (Nonsteroidal Anti-Inflammatory Drug) and/or non - biologic DMARD (Disease-Modifying Anti Rheumatic Drug) for peripheral joint involvement and switch to or addition of another NSAID /DMARDS'}, {'label': 'Biologic arm', 'description': 'Patients that have not responded to the current treatment with non biologic DMARDS (Disease-Modifying Anti Rheumatic Drug) /NSAID (Nonsteroidal Anti-Inflammatory Drug) and switch to or addition of adalimumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2P 0V2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Rheumatology Clinic /ID# 54768', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2P 3C5', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Associate Clinic /ID# 64274', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V1C 2R7', 'city': 'Cranbrook', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pont, Cranbrook, BC, CA /ID# 55242', 'geoPoint': {'lat': 49.49991, 'lon': -115.76879}}, {'zip': 'V2C 0B8', 'city': 'Kamloops', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Barbara T. Blumenauer Inc. /ID# 55226', 'geoPoint': {'lat': 50.66648, 'lon': -120.3192}}, {'zip': 'V2C 6G6', 'city': 'Kamloops', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Hudson, Kamloops, Canada /ID# 54577', 'geoPoint': {'lat': 50.66648, 'lon': -120.3192}}, {'zip': 'V9S 4S1', 'city': 'Nanaimo', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Maqbool R. Sheriff Inc. /ID# 55247', 'geoPoint': {'lat': 49.16638, 'lon': -123.94003}}, {'zip': 'V2A 3G7', 'city': 'Penticton', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Stewart, Penticton, CA /ID# 67096', 'geoPoint': {'lat': 49.48062, 'lon': -119.58584}}, {'zip': 'V2L 5R6', 'city': 'Prince George', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Michael Buchanan, Inc. /ID# 55227', 'geoPoint': {'lat': 53.9166, 'lon': -122.75301}}, {'zip': 'V6X 2C7', 'city': 'Richmond', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. J. Antonio Avina-Zubieta /ID# 68263', 'geoPoint': {'lat': 49.17003, 'lon': -123.13683}}, {'zip': 'V6Z 2E8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Alfonso Verdejo Inc. /ID# 54572', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8P 5P6', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Milton F. Baker Inc. /ID# 55197', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R3A IM3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Manitoba Clinic /ID# 54580', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E3B 6H5', 'city': 'Fredericton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Bulleid Henderson Prof. Corp. /ID# 55256', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}, {'zip': 'E3B 6H5', 'city': 'Fredericton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Ecker, Fredericton, CA /ID# 54748', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}, {'zip': 'A1B 5E8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Nexus Clinical Research /ID# 54757', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1C 5B8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': "St. Clare's Mercy Hospital /ID# 54767", 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Qe Ii Hsc /Id# 55261', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B1S 3N1', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Dr. Juris Lazovskis Inc. /ID# 61562', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'L9G 3K9', 'city': 'Ancaster', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pavlova, Hamilton, CA /ID# 65011', 'geoPoint': {'lat': 43.21806, 'lon': -79.98716}}, {'zip': 'L4M 6L2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Waterside Clinique /ID# 72174', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L6T 3J1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Joshi, Brampton, Canada /ID# 54758', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'K6V 5J9', 'city': 'Brockville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brockville Medical Center /ID# 65502', 'geoPoint': {'lat': 44.59132, 'lon': -75.68705}}, {'zip': 'L7L 0B7', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'L7R 1E2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Aviva Clinical Trial Group /ID# 54764', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'L9H 1B7', 'city': 'Dundas', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Chrisotomor Kouroukis & Dr /ID# 137831', 'geoPoint': {'lat': 43.27291, 'lon': -79.94216}}, {'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Charlton Medical Centre /ID# 133072', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Charlton Medical Centre /ID# 55417', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. William G. Bensen Centre /ID# 54762', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L9C 5N2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West Mountain Medical Center /ID# 128877', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N2M 5N6', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KW Musculoskeletal Research /ID# 70093', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'L5A 3V8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brandusa Florica Med Prof Corp /ID# 81877', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5A 3V8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Montgomery, Mississauga, CA /ID# 54581', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 2V8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley Rheumatology /ID# 54750', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 4N4', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Imtiaz MS Khan Medicine Prof /ID# 55401', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'K2G 6E2', 'city': 'Nepean', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Morassut, Nepean, Canada /ID# 55410', 'geoPoint': {'lat': 45.33619, 'lon': -75.7225}}, {'zip': 'L3Y 3R7', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Arthritis Program Res Grp /ID# 54755', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'L2E 6A6', 'city': 'Niagara Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rajwinder S. Dhillon Medicine /ID# 138671', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'K2A 3Z3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kapur, Ottawa, Canada /ID# 55397', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K2P 1V3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Davis, Ottawa, CA /ID# 55296', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'N4K 1S4', 'city': 'Owen Sound', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Setty, Owen Sound, CA /ID# 54583', 'geoPoint': {'lat': 44.56717, 'lon': -80.94349}}, {'zip': 'L2N 7E4', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Niagara Peninsula Arthritis Ct /ID# 67282', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'M4S 2C6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pedvis Med Prof Corp /ID# 55411', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4X 1W4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton, Toronto, CA /ID# 54575', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6S 4W4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Jonathan Stein Med Prof Corp /ID# 55451', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9C 5N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Karasik, Toronto, CA /ID# 54751', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9V 4B8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Samuel K Silverberg /ID# 55449', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H7T 2Z8', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Ctr de Med Sportive de Laval /ID# 54576', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H2L 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Rhum. de Montreal /ID# 54761', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital /ID# 63655', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1Y3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'PSS Medical Inc. /ID# 54754', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2V 3Z5', 'city': 'Outremont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Couture, Outremont, CA /ID# 54574', 'geoPoint': {'lat': 45.51564, 'lon': -73.60865}}, {'zip': 'G5L 8W1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': "Ctr. de Rheum de l'est du QC /ID# 54765", 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'H1S 3A9', 'city': 'Saint-Léonard', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Medicale Langelier /ID# 55460', 'geoPoint': {'lat': 45.58773, 'lon': -73.59501}}, {'zip': 'G1V 3M7', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Groupe de Recherche en Maladies Osseuses /ID# 45623', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'zip': 'G8Z 1Y2', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Ctr. de Recherche Musculo-Sque /ID# 55469', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'H3Z 2Z3', 'city': 'Westmount', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Rheum Disease Ctr of Montreal /ID# 143963', 'geoPoint': {'lat': 45.48341, 'lon': -73.59918}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'JSS Medical Research Inc.', 'class': 'INDUSTRY'}, {'name': 'Cato Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}