Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 10:27 AM
Study NCT ID:
NCT01625650
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions: The Corrona CERTAIN Sub-study
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood tests: at each study blood is obtained to examine, lipid levels with direct ( non fasting) LDL, a high sensitivity CRP as well as toxicity monitoring labs including a complete blood count and a comprehensive panel. During the baseline visit DNA is collected upon consent - to allow future genetic and pharmacogenetic studies- and also serology markers and immunoglobulin levels. During the first three visits RNA serum and plasma for storage and future experiments are collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2795}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Registry', 'RA', 'Biologic', 'Medications', 'Rheumatology'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '34047953', 'type': 'DERIVED', 'citation': 'Harrold LR, Bryson J, Lehman T, Zhuo J, Gao S, Han X, Schrader A, Rebello S, Pappas DA, Sommers T, Kremer JM. Association Between Baseline Anti-cyclic Citrullinated Peptide Antibodies and 6-Month Clinical Response Following Abatacept or TNF Inhibitor Treatment: A Real-World Analysis of Biologic-Experienced Patients with RA. Rheumatol Ther. 2021 Jun;8(2):937-953. doi: 10.1007/s40744-021-00310-2. Epub 2021 May 28.'}, {'pmid': '30868550', 'type': 'DERIVED', 'citation': 'Harrold LR, Litman HJ, Connolly SE, Alemao E, Kelly S, Rebello S, Hua W, Kremer JM. Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry. Rheumatol Ther. 2019 Jun;6(2):217-230. doi: 10.1007/s40744-019-0149-3. Epub 2019 Mar 13.'}, {'pmid': '27747515', 'type': 'DERIVED', 'citation': 'Pappas DA, John A, Curtis JR, Reed GW, Karki C, Magner R, Kremer JM, Shewade A, Greenberg JD. Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry. Rheumatol Ther. 2016 Jun;3(1):103-115. doi: 10.1007/s40744-016-0028-0. Epub 2016 Feb 8.'}], 'seeAlsoLinks': [{'url': 'http://www.CORRONA.org', 'label': 'CORRONA Inc. Web site'}]}, 'descriptionModule': {'briefSummary': 'The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North America, Inc. is a Sub-study of the CORRONA Data Collection Program.\n\nThe CERTAIN Sub-study is designed to systematically collect and document use patterns, effectiveness, comparative effectiveness and safety of biologic agents used in the management of Rheumatoid Arthritis (RA).', 'detailedDescription': "Biologic therapies (including biologic medications like Enbrel, Humira, Remicade, Cimzia, Simponi, Actemra, Rituxan and Orencia) have changed the treatment of RA, but the differences in safety and/or effectiveness of each biologic therapy are not all known. We are doing this study in order to try to see if one or more of these treatments are better than the others. The use of databases like the CORRONA Organization database gives us information that helps us to understand why such drugs are used, reasons for starting or stopping drugs, for whom they are prescribed, and to monitor changes in patients' abilities to perform daily activities and gather information on family or social history."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ppproximately 3,000 subjects from 100 sites will participate in this Sub-study and that approximately 30, and up to 200, subjects from this site will be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The CORRONA CERTAIN Sub-study is particularly focused on understanding the effectiveness and safety of biologic medications. Male and female patients, who\n\n 1. are at least 18 years of age;\n 2. have a documented diagnosis of RA by their treating rheumatologist;\n 3. have at least moderate disease activity; and\n 4. are initiating a biologic agent that has not be used for their treatment in the past are eligible to participate.\n\n Moderate disease activity is defined by a CDAI score greater than 10.\n\n Exclusion Criteria:\n\n Disease other than RA that do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01625650', 'acronym': 'CERTAIN', 'briefTitle': 'Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions: The Corrona CERTAIN Sub-study', 'organization': {'class': 'NETWORK', 'fullName': 'CorEvitas'}, 'officialTitle': 'The Corrona Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions Sub-study: The Corrona CERTAIN Sub-study', 'orgStudyIdInfo': {'id': 'New England IRB 02-021'}, 'secondaryIdInfos': [{'id': 'NEIRB 02-021', 'type': 'REGISTRY', 'domain': 'Corrona, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatology', 'description': 'Patients who present at enrolling sites across the US are invited to enroll if eligible.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12159', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'The Center For Rheumatoligy', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Dimitrios Pappas, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'CORRONA INC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CorEvitas', 'class': 'NETWORK'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}