Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT01581294
Status:
RECRUITING
Last Update Posted:
2022-08-23
First Post:
2012-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Norwegian Antirheumatic Drug Register
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': 'D025241', 'term': 'Spondylarthritis'}], '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': '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': 'Samples (including serum, plasma and full blood) for biomarker or DNA/RNA discovery and validation will be collected and stored in a freezer at -70 C at visits at baseline and at the 3-month assessment.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2012-04-18', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': 'Disease Activity Score-28 (DAS28)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Simplified Disease Activity Index (SDAI)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) remission', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Assessments of Spondyloarthritis International Society (ASAS) responses (ASAS20, ASAS40)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Modified Health Assessment Questionnaire (MHAQ)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Rheumatoid Arthritis Impact of Disease (RAID)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Work Productivity and Activity Impairment (WPAI) Questionnaire', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'EuroQol 5-dimensions (EQ-5D) questionnaire', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months', 'description': 'Utility instrument'}, {'measure': '28-Swollen joint count', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': '28-Tender joint count', 'timeFrame': 'All follow-up visits'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}, {'measure': 'Sharp/van der Heijde score', 'timeFrame': '12, 24, 36, 48, 60 months', 'description': 'Radiographic progression'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 months'}, {'measure': 'Clinical Disease Activity Index (CDAI)', 'timeFrame': '3, 6, 9, 12, 18, 24, 36, 48, 60 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Psoriatic arthritis', 'Ankylosing spondylitis', 'Spondyloarthritis'], 'conditions': ['Inflammatory Joint Diseases']}, 'referencesModule': {'references': [{'pmid': '32648248', 'type': 'DERIVED', 'citation': 'Mielnik P, Sexton J, Lie E, Bakland G, Loli LP, Kristianslund EK, Rodevand E, Lexberg AS, Kvien TK. Does Older Age have an Impact on Rituximab Efficacy and Safety? Results from the NOR-DMARD Register. Drugs Aging. 2020 Aug;37(8):617-626. doi: 10.1007/s40266-020-00782-x.'}, {'pmid': '31783773', 'type': 'DERIVED', 'citation': 'Gehin JE, Goll GL, Warren DJ, Syversen SW, Sexton J, Strand EK, Kvien TK, Bolstad N, Lie E. Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study. Arthritis Res Ther. 2019 Nov 29;21(1):256. doi: 10.1186/s13075-019-2009-5.'}, {'pmid': '30508189', 'type': 'DERIVED', 'citation': 'Olsen IC, Lie E, Vasilescu R, Wallenstein G, Strengholt S, Kvien TK. Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry. Rheumatology (Oxford). 2019 Mar 1;58(3):481-491. doi: 10.1093/rheumatology/key338.'}]}, 'descriptionModule': {'briefSummary': 'NOR-DMARD is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. Other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological DMARDs on work participation and work productivity, to investigate different strategies for use of biological DMARDs, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological DMARDs.', 'detailedDescription': 'This study is a modification, and an extension, of the NOR-DMARD study that was conducted in 5 Norwegian rheumatology departments in the period 2000-2012. The study includes a structured follow-up with study visits at baseline (start of biological drug) and after 3, 6, 12 months and every 12 months thereafter. Each study visit includes clinical assessment, patient-reported outcomes and measurement of acute-phase reactants. The data collection also includes blood samples for biobank at baseline and 3 months. Serious adverse events data will be systematically recorded, but other adverse events can also be retrieved by linkage to other registers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with inflammatory arthropathies starting a new treatment with a biological disease modifying anti-rheumatic drug', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, or any other inflammatory arthritis\n* Clinical indication to start a new treatment with a biological disease modifying anti-rheumatic drug or a kinase inhibitor\n\nExclusion Criteria:\n\n* Unwillingness or unability to give written informed consent\n* Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible\n* Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol'}, 'identificationModule': {'nctId': 'NCT01581294', 'acronym': 'NOR-DMARD', 'briefTitle': 'The Norwegian Antirheumatic Drug Register', 'organization': {'class': 'OTHER', 'fullName': 'Diakonhjemmet Hospital'}, 'officialTitle': 'Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study', 'orgStudyIdInfo': {'id': 'DIA 2011-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Drammen', 'state': 'Buskerud', 'status': 'COMPLETED', 'country': 'Norway', 'facility': 'Vestre Viken HF Drammen Hospital', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'zip': '2609', 'city': 'Lillehammer', 'state': 'Oppland', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Yi Hu, MD PhD', 'role': 'CONTACT', 'email': 'Yi.Hu@revmatismesykehuset.no'}, {'name': 'Yi Hu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lillehammer Hospital for Rheumatic Diseases', 'geoPoint': {'lat': 61.11514, 'lon': 10.46628}}, {'zip': '6807', 'city': 'Førde', 'state': 'Sogn Og Fjordane', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Pawel F Mielnik, MD, PhD', 'role': 'CONTACT', 'email': 'pawel.franciszek.mielnik@helse-forde.no', 'phone': '+4757839000'}, {'name': 'Pawel F Mielnik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Førde Hospital', 'geoPoint': {'lat': 61.45217, 'lon': 5.85717}}, {'zip': '7006', 'city': 'Trondheim', 'state': 'Sør-Trøndelag', 'status': 'COMPLETED', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '9038', 'city': 'Tromsø', 'state': 'Troms', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Synøve Kalstad, MD', 'role': 'CONTACT', 'email': 'Synove.Kalstad@unn.no', 'phone': '+4791507766'}, {'name': 'Synøve Kalstad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Northern Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '0319', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Eirik K Kristianslund, MD, PhD', 'role': 'CONTACT', 'email': 'eirik.kristianslund@gmail.com'}, {'name': 'Espen A Haavardsholm, MD, PhD', 'role': 'CONTACT', 'email': 'e.a.haavardsholm@medisin.uio.no', 'phone': '+4722454086'}, {'name': 'Tore K Kvien, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eirik K Kristianslund, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Espen A Haavardsholm, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Diakonhjemmet Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Eirik K Kristianslund, MD, PhD', 'role': 'CONTACT', 'email': 'eirik.kristianslund@gmail.com'}, {'name': 'Espen A Haavardsholm, MD, PhD', 'role': 'CONTACT', 'email': 'e.a.haavardsholm@medisin.uio.no', 'phone': '+4722454086'}], 'overallOfficials': [{'name': 'Tore K Kvien, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diakonhjemmet Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Lillehammer Hospital for Rheumatic Diseases', 'class': 'OTHER'}, {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, {'name': 'Helse Forde', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tore K Kvien', 'investigatorAffiliation': 'Diakonhjemmet Hospital'}}}}