Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-27 @ 5:38 AM
Study NCT ID:
NCT01476956
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2011-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* whole blood/serum\n* urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2011-06-01', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).', 'timeFrame': '24 Months'}], 'secondaryOutcomes': [{'measure': 'To establish which modifiable clinical and laboratory predictors used in routine practice individually and in combination, have the strongest and the most consistent association with change in radiographic damage in patients on standard RA therapy.', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31523049', 'type': 'DERIVED', 'citation': 'Sepriano A, Ramiro S, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewe R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.'}, {'pmid': '31474600', 'type': 'DERIVED', 'citation': 'Maksymowych WP, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewe R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.\n\nDisease activity will be monitored systematically every 3 months by the Disease Activity Score.\n\nChanges in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies.\n\nBiomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum.\n\nRadiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).\n\nPatients will be followed for 2 years.', 'detailedDescription': 'Treatment is Disease Activity Score (DAS) driven. Changes in standard DMARD and/or anti-TNFα therapy will be implemented according to 2010 European League against Rheumatism (EULAR) recommendations which state a target of remission (DAS44 \\<1.6) for patients receiving standard DMARD therapy in the setting of early disease and a target of low disease activity state (LDAS) (DAS44 ≤2.4) for patients receiving anti-TNFα therapy in the setting of established disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "RA patients from rheumatologists' clinics", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (selected):\n\n* 18 years of age or older\n* RA according to the 2010 Rheumatoid Arthritis Classification Criteria\n* Joint symptoms for ≥ 3 months prior to screening\n* DAS44 \\> 2.4\n* About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or\n\n * increased dose of methotrexate by ≥10 mg weekly to a maximum dose of 25mg weekly (if already receiving \\>15mg will require add-on DMARD/anti-TNF or switch to alternative DMARD),\n * add-on of alternative DMARD,\n * switch to alternative DMARD,\n * start of first anti-TNFα agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)\n* If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit\n* If already on systemic steroid, dose must be stable (prednisone ≤ 7.5mg/day) for 1 month prior to the baseline visit\n* Patient will be available for follow up for a minimum of 24 months from the baseline visit\n\nExclusion Criteria (selected):\n\n* Intra-articular steroid injection within 4 weeks prior to the baseline visit\n* Prior treatment with anti-TNFα or other biological agent (rituximab, abatacept, tocilizumab)\n* Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ)\n* History of:\n\n * Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 3 months prior to the baseline visit;\n * Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative)\n* For patients starting anti-TNF therapy, a positive TB screening test and no record of effective prophylaxis according to local expert recommendations\n* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C'}, 'identificationModule': {'nctId': 'NCT01476956', 'briefTitle': 'Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography', 'organization': {'class': 'INDUSTRY', 'fullName': 'CARE ARTHRITIS LTD.'}, 'officialTitle': 'Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'RA BIODAM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis', 'interventionNames': ['Other: Observational study']}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'RA patients on standard DMARD therapy', 'armGroupLabels': ['Rheumatoid Arthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Arthritis Center, Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Rheumatologist Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Division of Rheumatology, Columbia University, College of Physicians and Surgeons', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Division of Allergy, Immunology and Rheumatology, University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Rheumatology Associates', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Division of Rheumatology, University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3A 1M4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Arthritis Center, University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1C 5B3', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Memorial University', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L3Y 3R7', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Arthritis Research Group', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'S7K 0H6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Osteoporosis Centre', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Copenhagen University Hospital at Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Service de Rheumatologie-CHU Bordeaux Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': "Le Roux Liana, Centre d'Investigation Clinique", 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Lille', 'country': 'France', 'facility': "Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Departement de rheumatologie, Hopital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Rheumatologie B, Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': 'D-61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '39261', 'city': 'Zerbst', 'country': 'Germany', 'facility': 'Dr Spieler', 'geoPoint': {'lat': 51.9662, 'lon': 12.08517}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Department of Rheumatology, St. Vincents University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Centre', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '44121', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'University of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'University of Milan', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Day Hospital Reumatologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University of the Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '37067', 'city': 'Verona', 'country': 'Italy', 'facility': 'Department of Rheumatology, University of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '0157 AB Amsterdam', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam VU University Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1100 DE Amsterdam', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Centre/University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6419 PC Heerlen', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '2300 RC Leiden', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Afdeling Reumatologie, Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': 'N-0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Rheumatology, Diakonhjemmet Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Walter P. Maksymowych, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CaRE Arthritis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CARE ARTHRITIS LTD.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}