Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 7:04 PM
Study NCT ID:
NCT01219257
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2010-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013585', 'term': 'Synovitis'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'C529000', 'term': 'golimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'At the first visit, one glass with blood will be frozen for later genetical analyzes, all related to questions regarding SpA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2010-09-15', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.', 'timeFrame': 'Including patients for about 1.5 years', 'description': 'The joints will be assessed according to a US atlas by use of a semi-quantitative (0-3) scoring system and the entheses will be evaluated according to internationally accepted scoring methods.'}], 'secondaryOutcomes': [{'measure': '1. Explore whether the US (B-mode and power Doppler) scores at baseline or after 3 months predict patients responding to biological treatment after 6 and 12 months.', 'timeFrame': '2.5 years'}, {'measure': '2. Explore whether the sensitivity for change is higher for US (B-mode and/or power Doppler) than for the traditional assessments for inflammatory activity.', 'timeFrame': '2.5 years'}, {'measure': '3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.', 'timeFrame': '2.5 years'}, {'measure': '4. Explore whether the different subgroups of spondylarthritis patients have different US response (B-mode synovitis and power Doppler in joints and entheses) to biological treatment.', 'timeFrame': '2.5 years'}, {'measure': "5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.", 'timeFrame': '2.5 years'}, {'measure': '6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity.', 'timeFrame': '2.5 years', 'description': 'Calprotectin, a major granulocyte protein, is assessed by use of ELISA in plasma. Plasma samples will be frozen at all visits, and the calprotectin assessments will be performed when all patients have finished the study.'}, {'measure': '7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.', 'timeFrame': '2.5 years', 'description': 'Plasma and serum will be frozen at each visit, and the S100 proteins calprotectin as well as A12 will be assessed. In addition, other relevant biomarkers may be analyzed after 2.5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SpA', 'Anti-TNF alpha treatment', 'Ultrasonography', 'Synovitis', 'Enthesitis'], 'conditions': ['Spondyloarthritis', 'Ultrasonography']}, 'descriptionModule': {'briefSummary': 'Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response.\n\nThe present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.\n\nThe objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'SpA patients with high disease activity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SpA\n* Planning to start anti-TNF alpha treatment\n\nExclusion Criteria:\n\n* Patients not being able to communicate in Norwegian or not being able to fill in questionnaires\n* Surgery in more than 5 of the joints/entheses to be examined by US'}, 'identificationModule': {'nctId': 'NCT01219257', 'acronym': 'ULSPABIT', 'briefTitle': 'Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Diakonhjemmet Hospital'}, 'officialTitle': 'Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.', 'orgStudyIdInfo': {'id': '011110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SpA patients', 'description': 'The patients may be included when their rheumatologist has decided that the patient are going to start biological medication.', 'interventionNames': ['Biological: Anti-TNF alpha therapy']}], 'interventions': [{'name': 'Anti-TNF alpha therapy', 'type': 'BIOLOGICAL', 'otherNames': ['Adalimumab (HumiraR)', 'Etanercept (EnbrelR)', 'Infliximab (RemicadeR)', 'Golimumab (SimponiR)'], 'description': 'All medical treatment will be standardizes following good medical practice', 'armGroupLabels': ['SpA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0319', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Rheumatology, Diakonhjemmet Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Hilde B Hammer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diakonhjemmet Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant, PhD', 'investigatorFullName': 'Hilde Berner Hammer', 'investigatorAffiliation': 'Diakonhjemmet Hospital'}}}}