Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 9:36 PM
Study NCT ID:
NCT03440892
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2018-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients
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': 'D008727', 'term': 'Methotrexate'}, {'id': 'D012460', 'term': 'Sulfasalazine'}, {'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C000596027', 'term': 'baricitinib'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivin status', 'timeFrame': '6 months', 'description': 'Patients with a survivin level of over 0.45 ng/ml are considered to be survivin positive.\n\nPatients with survivin levels under 0.45 ng/ml are considered to be survivin negative\n\nA change from survivin positive to survivin negative (or vice versa) equals conversion of survivin status.'}], 'secondaryOutcomes': [{'measure': 'Disease activity (DAS28)', 'timeFrame': '6 months', 'description': "Disease activity, DAS28, is calculated using a specific formula based on:\n\n* number of painful joints from 28 joints\n* number of swollen joints from 28 joints\n* erythrocyte sedimentation rate (ESR) or C reactive protein (CRP)\n* patient's global assessment of disease activity on a 100 mm visual analogue scale (VAS)\n\nDAS thresholds:\n\nDAS28 below 3.2: low disease activity DAS28 over 3.2 and under 5.1: moderate disease activity DAS28 above 5.1: high disease activity DAS28 lower than 2.6: remission"}, {'measure': 'Response to treatment', 'timeFrame': '6 months', 'description': 'The EULAR response criteria classify patients as good, moderate, or non-responders, using the change in DAS28 and the level of DAS28 reached. A patient must show a significant change as well as low disease activity to be classified as a good responder.\n\nGood responder: DAS28 scores ≤ 3.2 with reductions in DAS28 \\>1.2 Moderate responder: DAS28 scores \\> 3.2 with reductions in DAS28 \\>1.2 Non-responder: reductions in DAS28 ≤ 0.6'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['survivin', 'biomarker of pharmacological response', 'antirheumatic treatment', 'methotrexate', 'sulfasalazin', 'abatacept', 'tocilizumab', 'tofacitinib/baricitinib'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.', 'detailedDescription': 'In a prospective observational study the investigators aim to study the ability of modern antirheumatic treatments to suppress levels of survivin in sera. Rheumatoid arthritis patients scheduled to start new pharmacological treatment will be followed for a period of 6 months. No intervention or influence on choice of treatment will be performed, the decision of new/other medication is entirely made by the patient and their rheumatologist. The study entails addition of survivin analyse (1 vial of sera) before and after start of new treatment. Data concerning survivin levels, disease activity and other clinical parameters before and after start of new treatment will also be analysed. The patients will leave sera for survivin analyse at baseline and 3 and 6 months after start of new treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rheumatoid arthritis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients fulfilling the RA classification criteria according to the ACR/EULAR\n\nExclusion Criteria:\n\n* Patients at stable/unchanged anti-rheumatic treatment\n* Other serious physical or mental illness\n* Lack of knowledge in Swedish making answering the questionnaires impossible'}, 'identificationModule': {'nctId': 'NCT03440892', 'acronym': 'SurviTreat', 'briefTitle': 'Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin', 'orgStudyIdInfo': {'id': 'Survivin in Treatment'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Drug: methotrexate', 'Drug: sulfasalazine', 'Drug: abatacept', 'Drug: tocilizumab', 'Drug: tofacitinib/baricitinib']}], 'interventions': [{'name': 'methotrexate', 'type': 'DRUG', 'description': 'folate antagonist', 'armGroupLabels': ['1']}, {'name': 'sulfasalazine', 'type': 'DRUG', 'otherNames': ['Salazopyrin'], 'description': 'Immunomodulatory', 'armGroupLabels': ['1']}, {'name': 'abatacept', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': 'Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)', 'armGroupLabels': ['1']}, {'name': 'tocilizumab', 'type': 'DRUG', 'otherNames': ['RoActemra'], 'description': 'IL-6 receptor antagonist', 'armGroupLabels': ['1']}, {'name': 'tofacitinib/baricitinib', 'type': 'DRUG', 'otherNames': ['Xeljanz/Olumiant'], 'description': 'JAK inhibitor', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sofia T Silfverswärd', 'role': 'CONTACT', 'email': 'sofia.silfversward@rheuma.gu.se'}], 'facility': 'Dept of Rheumatology and Inflammation research', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Maria Bokarewa, MD', 'role': 'CONTACT', 'email': 'maria.bokarewa@rheuma.gu.se'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}