Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02132234
Status:
UNKNOWN
Last Update Posted:
2014-05-07
First Post:
2014-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000068582', 'term': 'Certolizumab Pegol'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-05-05', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in immune cell subset populations from baseline', 'timeFrame': 'prior to receiving anti-TNF-α treatment, 12 weeks', 'description': 'determination of subsets, activation markers, intracellular cytokine production'}], 'primaryOutcomes': [{'measure': 'Change from baseline in blood pressure', 'timeFrame': 'prior to receiving anti-TNF-α treatment, 12 weeks', 'description': 'Ambulatory Blood Pressure Monitoring (ABPM)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in endothelial function', 'timeFrame': 'prior to receiving anti-TNF-α treatment, 12 weeks', 'description': 'Flow Mediated Dilatation / Endo Pat'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Ankylosing Spondylitis', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients suffering from rheumatoid arthritis:\n\n* rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987\n* ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)\n* high disease activity - Disease Activity Score 28 (DAS 28) \\> 5,1 measured twice, with a 1-month interval\n* for patients with mainly lower limbs affected with DAS 28 \\> 3,7\n\nFor patients suffering from Ankylosing Spondylitis:\n\n* Ankylosing Spondylitis diagnosed based on Modified New York Criteria\n* ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months\n* high disease activity -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \\> 4 measured twice, with a 12-week interval\n* spinal pain \\> 4cm on 10cm Visual Analogue Scale (VAS) measured twice, with a 12-week interval\n* general disease activity assessment \\> 5 (0-10 scale) performed after the 2nd VAS and BASDAI assessment\n\nFor patients suffering from Psoriatic Arthritis:\n\n\\- Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)\n\nIf peripheral joints are affected:\n\nactive disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months\n\nCriteria of active disease (all have to be met):\n\n* At least 5 out of 66 joints swollen - assessed twice, with a 4-week interval\n* At least 5 out of 68 joints tender - assessed twice, with a 4-week interval\n* general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by patient\n* general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by physician\n* general disease activity assessment \\> 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints\n\nIf axial joints are affected:\n\n* Sacroiliac joints affected according to the New York Criteria of Ankylosing Spondylitis\n* Active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each\n\nCriteria of active disease (all must be present):\n\n* BASDAI \\> 4 measured twice, with a 12-week interval\n* spinal pain \\> 4cm on 10 cm in the VAS measured twice, with a 12-week interval\n* general disease activity assessment \\> 5 (0-10 scale) Patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone.\n\nExclusion Criteria:\n\n* non-consenting patient\n* pregnancy\n* breast-feeding\n* allergy for the drug or any component\n* cardiac insufficiency (NYHA III or IV)\n* active infection\n* infection within the last 3 months: hepatitis, pneumonia, pyelonephritis\n* opportunistic infection within the last 2 months: active infection of cytomegalovirus, Pneumocystis carinii\n* joint infection within the last 12 months\n* endoprosthesis infection within the last 12 months or any time if the joint was not replaced\n* exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment\n* demyelinating disease or its symptoms\n* pancytopenia or aplastic anemia\n* pre-cancer stage\n* neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression\n* active alcoholic disease\n* chronic liver disease'}, 'identificationModule': {'nctId': 'NCT02132234', 'briefTitle': 'Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'UJ-KChWiMWsi-Reu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological treatment', 'description': 'Patients with high disease activity receiving biological treatment according to rheumatologic indication:\n\n* etanercept 50 mg s.c. every week\n* adalimumab 40 mg s.c. every 2 weeks\n* certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks\n* infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks', 'interventionNames': ['Drug: Etanercept', 'Drug: Adalimumab', 'Drug: Certolizumab', 'Drug: Infliximab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Patients with high disease activity receiving other than biological treatment and receiving placebo.'}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'description': 'biological treatment according to rheumatologic indication', 'armGroupLabels': ['Biological treatment']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': 'biological treatment according to rheumatologic indication', 'armGroupLabels': ['Biological treatment']}, {'name': 'Certolizumab', 'type': 'DRUG', 'description': 'biological treatment according to rheumatologic indication', 'armGroupLabels': ['Biological treatment']}, {'name': 'Infliximab', 'type': 'DRUG', 'description': 'biological treatment according to rheumatologic indication', 'armGroupLabels': ['Biological treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-121', 'city': 'Krakow, Skarbowa 4', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Bogdan Batko, MD, PhD', 'role': 'CONTACT', 'phone': '48126876261'}, {'name': 'Agata Schramm, MD', 'role': 'CONTACT', 'phone': '48126876210'}, {'name': 'Tomasz Guzik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bogdan Batko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Agata Schramm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Tomasz Guzik, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jagiellonian University'}, {'name': 'Bogdan Batko, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology, J. Dietl Hospital, Krakow, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Tomasz Guzik', 'investigatorAffiliation': 'Jagiellonian University'}}}}