Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00902005
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2009-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], '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'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-20', 'studyFirstSubmitDate': '2009-05-13', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the association between inflammatory disease activity and endothelial function in RA and spondyloarthritis patients treated with methotrexate and TNFalpha-inhibitor in combination or methotrexate or TNFalpha-inhibitor alone', 'timeFrame': 'Baseline (before treatment starts), 6 weeks and 6 months after starting treatment'}], 'secondaryOutcomes': [{'measure': 'CRP (C-reactive protein)', 'timeFrame': 'Baseline (before starting treatment), 6 weeks, 6 months after starting treatment'}, {'measure': 'DAS28 (Disease activity score)', 'timeFrame': 'Baseline (before starting treatment), 6 weeks, 6 months after starting treatment'}, {'measure': 'COMP (cartilage oligomeric matrix protein 1)', 'timeFrame': 'Baseline (before starting treatment), 6 weeks, 6 months after starting treatment'}, {'measure': 'IL-6 (interleukin 6)', 'timeFrame': 'Baseline (before starting treatment), 6 weeks, 6 months after starting treatment'}, {'measure': 's-RAGE (Receptor of Advanced Glycation End products)', 'timeFrame': 'Baseline (before starting treatment), 6 weeks, 6 months after starting treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endothelial dysfunction', 'Bone and cartilage markers', 'Inflammatory disease activity', 'Rheumatoid arthritis', 'Psoriatic arthritis', 'Ankylosing Spondylitis'], 'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Ankylosing Spondylitis', 'Endothelial Dysfunction', 'Inflammatory Disease Activity']}, 'referencesModule': {'references': [{'pmid': '31335881', 'type': 'DERIVED', 'citation': 'Hokstad I, Deyab G, Wang Fagerland M, Lyberg T, Hjeltnes G, Forre O, Agewall S, Mollnes TE, Hollan I. Tumor necrosis factor inhibitors are associated with reduced complement activation in spondylarthropathies: An observational study. PLoS One. 2019 Jul 23;14(7):e0220079. doi: 10.1371/journal.pone.0220079. eCollection 2019.'}, {'pmid': '29041979', 'type': 'DERIVED', 'citation': 'Deyab G, Hokstad I, Whist JE, Smastuen MC, Agewall S, Lyberg T, Ronda N, Mikkelsen K, Hjeltnes G, Hollan I. Methotrexate and anti-tumor necrosis factor treatment improves endothelial function in patients with inflammatory arthritis. Arthritis Res Ther. 2017 Oct 17;19(1):232. doi: 10.1186/s13075-017-1439-1.'}, {'pmid': '25605003', 'type': 'DERIVED', 'citation': 'Ronda N, Greco D, Adorni MP, Zimetti F, Favari E, Hjeltnes G, Mikkelsen K, Borghi MO, Favalli EG, Gatti R, Hollan I, Meroni PL, Bernini F. Newly identified antiatherosclerotic activity of methotrexate and adalimumab: complementary effects on lipoprotein function and macrophage cholesterol metabolism. Arthritis Rheumatol. 2015 May;67(5):1155-64. doi: 10.1002/art.39039.'}, {'pmid': '22660798', 'type': 'DERIVED', 'citation': 'Hjeltnes G, Hollan I, Forre O, Wiik A, Lyberg T, Mikkelsen K, Agewall S. Relations of serum COMP to cardiovascular risk factors and endothelial function in patients with rheumatoid arthritis treated with methotrexate and TNF-alpha inhibitors. J Rheumatol. 2012 Jul;39(7):1341-7. doi: 10.3899/jrheum.111401. Epub 2012 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with RA and spondyloarthritis starting with either combination therapy of TNFalpha-inhibitor and methotrexate or methotrexate or TNFalpha-inhibitor alone, at Lillehammer Hospital for Rheumatic diseases.Decision about treatment modality will be based on conventional clinial judgement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females 18-80 years\n* Able and willing to give written informed consent, and to comply with the requirements of the study protocol.\n* Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis, or the diagnostic criteria by Moll and Wright for the diagnosis psoriatic arthritis, or the modified New York diagnostic criteria for ankylosing spondylitis.\n* Clinical indication for starting treatment with methotrexate, TNFalpha- inhibitor or combination therapy.\n* Use of reliable method of contraception for women with childbearing potential.\n\nExclusion Criteria:\n\n* Lack of cooperativity\n* Positive serology for hepatitis B or C\n* History of positive HIV status.\n* History of tuberculosis or untreated tuberculosis.\n* PPD more than 15 mm in previously BCG immunized subjects. PPD 6 mm or more if not previously BCG immunized.\n* Histoplasmosis or Listeriosis\n* Persistent or recurrent infections\n* Any inflammatory disease of permanence not related to RA, PSA or AS.\n* Pregnancy or breast-feeding.\n* Use of prednisolone more than 10 mg daily for 2 weeks at inclusion.\n* Use of TNFalpha-inhibitor the last 4 weeks.\n* History of cancer.\n* Uncontrolled diabetes.\n* Congestive heart failure (Nyha 3-4)\n* Recent stroke (within 3 months)\n* Previous diagnosis or signs of central nervous system demyelinating disease.\n* Previously diagnosed immunodeficiency.'}, 'identificationModule': {'nctId': 'NCT00902005', 'acronym': 'PSARA', 'briefTitle': 'Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Revmatismesykehuset AS'}, 'officialTitle': 'Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in RA and Spondyloarthritis Patients, Treated With TNFalpha-inhibitors in Combination With Methotrexate or Methotrexate or TNFalpha-inhibitors Alone - a Prospective Study', 'orgStudyIdInfo': {'id': 'S-07377b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatic patients', 'description': 'Three groups:\n\nRA patients: 30 starting on Methotrexate, 30 starting on combination of Methotrexate and TNFalpha inhibitor.\n\nPSA patients: 20 starting on Methotrexate, 20 starting on combination of Methotrexate and TNFalpha inhibitor.\n\nAS patients: 20 starting on TNFalpha inhibitor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2609', 'city': 'Lillehammer', 'state': 'Oppland', 'country': 'Norway', 'facility': 'Lillehammer Hospital for Rheumatic Diseases', 'geoPoint': {'lat': 61.11514, 'lon': 10.46628}}], 'overallOfficials': [{'name': 'Knut Mikkelsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lillehammer Hospital for Rheumatic Diseases'}, {'name': 'Gunnbjørg Hjeltnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lillehammer Hospital for Rheumatic Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revmatismesykehuset AS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}