Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-07 @ 1:13 AM
Study NCT ID:
NCT00477893
Status:
UNKNOWN
Last Update Posted:
2012-03-28
First Post:
2007-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Danish Multicenter Study of Adalimumab in Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}], '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-27', 'studyFirstSubmitDate': '2007-05-23', 'studyFirstSubmitQcDate': '2007-05-23', 'lastUpdatePostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in BASDAI of 20 mm or 50%', 'timeFrame': '12-24 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '26414004', 'type': 'DERIVED', 'citation': 'Pedersen SJ, Poddubnyy D, Sorensen IJ, Loft AG, Hindrup JS, Thamsborg G, Asmussen K, Hendricks O, Norregaard J, Piil AD, Moller JM, Jurik AG, Balding L, Lambert RG, Sieper J, Ostergaard M. Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. Arthritis Rheumatol. 2016 Feb;68(2):418-29. doi: 10.1002/art.39434.'}]}, 'descriptionModule': {'briefSummary': 'Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.', 'detailedDescription': 'See brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria\n2. Clinical active disease, defined as a BASDAI score \\> 4 despite concurrent NSAID therapy\n3. Presence of sacroiliitis on conventional radiography or MRI.\n4. Among other issues: Age \\>18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists\n\nExclusion Criteria:\n\n1. Previous TNFα inhibitor therapy\n2. Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening\n3. Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening\n4. Pregnancy or lactation\n5. HIV, hepatitis B or C, tuberculosis, other infections\n6. Malignancies\n7. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)\n8. Contraindications to anti-TNFa-therapy\n9. Contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT00477893', 'acronym': 'DANISH', 'briefTitle': 'Danish Multicenter Study of Adalimumab in Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab', 'orgStudyIdInfo': {'id': 'HUM 04-078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adalimumab', 'interventionNames': ['Drug: Adalimumab']}], 'interventions': [{'name': 'Adalimumab', 'type': 'DRUG', 'description': 'sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study', 'armGroupLabels': ['Adalimumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Department of Radiology, Aabenraa Hospital', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Radiology, Århus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Radiology, Herlev University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Bispebjerg University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Gentofte University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Glostrup University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Herlev University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Gråsten', 'country': 'Denmark', 'facility': 'King Christian X´s Hospital of Rheumatic Diseases', 'geoPoint': {'lat': 54.91918, 'lon': 9.59523}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Hørsholm Hospital', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Slagelse', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}, {'city': 'Vejle', 'country': 'Denmark', 'facility': 'Department of Radiology, Vejle Hospital,', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'city': 'Vejle', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Inge Juul Sørensen, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology, Glostrup University Hospital'}, {'name': 'Susanne Juhl Pedersen, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology, Glostrup University Hospital'}, {'name': 'Mikkel Ostergaard, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rheumatology, Glostrup University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'MOstergaard', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}