Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 4:06 PM
Study NCT ID:
NCT01706692
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss Dermatology Network of Targeted Therapies (SDNTT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'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': 'D000069549', 'term': 'Ustekinumab'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D008727', 'term': 'Methotrexate'}], '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'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1121}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2032-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2012-09-19', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse and serious adverse events', 'timeFrame': '10 years', 'description': 'Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis'}], 'primaryOutcomes': [{'measure': 'Psoriasis Area Severity Index (PASI)', 'timeFrame': 'every 6 months for 10 years', 'description': 'To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis'}], 'secondaryOutcomes': [{'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'every 6 months for 10 years', 'description': 'To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Methotrexate', 'Acitretin', 'Cyclosporine A', 'Systemic PUVA', 'Infliximab', 'Adalimumab', 'Etanercept', 'Ustekinumab', 'Fumaric acids', 'Psoriasis', 'Psoriatic arthritis', 'Skin disease'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.sdntt.ch', 'label': 'SDNTT'}, {'url': 'http://www.psobest.de/', 'label': 'German registry PsoBest'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy.\n\nThe registry will also evaluate safety clinical outcomes and health related quality of life.', 'detailedDescription': 'Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland is largely performed with systemic therapies. This includes conventional systemic therapy such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and biological treatments such as etanercept, infliximab, adalimumab and within a pre-registration program ustekinumab. While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. SDNTT, the Swiss registry on the treatment of moderate to severe Pso and PsA documents the long-term course of patients being administered a defined biologic or conventional systemic drug. Following outcomes are observed: Effectiveness on the long-term, of combined/alternating treatments and under comorbidity conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of response and safety.\n\nThe study evaluates the long-term course of patients with Pso and PsA in systemic treatments. A patient will be included at first initiation of the treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment will consecutively enroll patients. Follow-ups will be every 3 months, comprising patient and treatment characteristics, clinical parameters, patient-defined benefit, quality of life and adverse events. Standardized questionnaires will be addressed to the patient and to the dermatologist 12 times at the dermatologic centres. In interim intervals, patients are directly contacted another 9 times by mail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with psoriasis or psoriatic-arthritis meeting the inclusion criteria and not meeting the exclusion criteria will be eligible to participate in this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist,\n* age ≥ 18,\n* Being administered a specific biologic/conventional systemic drug for the first time\n* Sufficient language skills (German, French, Italian and English) for the informed consent to participate\n* Informed consent to participate\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Patients being participants of clinical trials at the day of registration to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analyzed separately)'}, 'identificationModule': {'nctId': 'NCT01706692', 'acronym': 'SDNTT', 'briefTitle': 'Swiss Dermatology Network of Targeted Therapies (SDNTT)', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Dermatology Network for Targeted Therapies'}, 'officialTitle': 'Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics', 'orgStudyIdInfo': {'id': 'IMM 10-0138; P21007224R'}, 'secondaryIdInfos': [{'id': 'CNTO1275PSO4028; AG110401-IIR', 'type': 'OTHER_GRANT', 'domain': 'AbbVie, Almirall, Janssen Pharmaceutica, Eli Lilly, UCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adalimumab', 'description': 'Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed', 'interventionNames': ['Biological: Adalimumab']}, {'label': 'Etanercept', 'description': 'Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed', 'interventionNames': ['Biological: Etanercept']}, {'label': 'Infliximab', 'description': 'Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed', 'interventionNames': ['Biological: Infliximab']}, {'label': 'Ustekinumab', 'description': 'Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed', 'interventionNames': ['Biological: Ustekinumab']}, {'label': 'Cyclosporine A', 'description': 'Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed', 'interventionNames': ['Drug: Cyclosporine A']}, {'label': 'Fumaric acids', 'description': 'Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed', 'interventionNames': ['Drug: Fumaric acids']}, {'label': 'Methotrexate', 'description': 'Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed', 'interventionNames': ['Drug: Methotrexate']}, {'label': 'Other anti-psoriatic systemic treatments', 'description': 'e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed', 'interventionNames': ['Drug: Other anti-psoriatic systemic treatments']}], 'interventions': [{'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira'], 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Adalimumab']}, {'name': 'Etanercept', 'type': 'BIOLOGICAL', 'otherNames': ['Enbrel'], 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Etanercept']}, {'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Remicade'], 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Infliximab']}, {'name': 'Ustekinumab', 'type': 'BIOLOGICAL', 'otherNames': ['Stelara'], 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Ustekinumab']}, {'name': 'Cyclosporine A', 'type': 'DRUG', 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Cyclosporine A']}, {'name': 'Fumaric acids', 'type': 'DRUG', 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Fumaric acids']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Methotrexate']}, {'name': 'Other anti-psoriatic systemic treatments', 'type': 'DRUG', 'description': 'all dosages, frequencies and durations prescribed', 'armGroupLabels': ['Other anti-psoriatic systemic treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-5001', 'city': 'Aarau', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Marcus Streit, Dr. med.', 'role': 'CONTACT', 'email': 'markus.streit@ksa.ch', 'phone': '062 838 68 38'}, {'name': 'Marcus Streit, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarau Cantonal Hospital', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': 'CH-4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Alexander Navarini, Prof.', 'role': 'CONTACT', 'email': 'Alexander.Navarini@usb.ch'}, {'name': 'Alexander Navarini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Basel University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-3001', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Luca Borradori, Prof.', 'role': 'CONTACT', 'email': 'Luca.Borradori@insel.ch', 'phone': '031 632 2111'}, {'name': 'Nikhil Yawalkar, Prof.', 'role': 'CONTACT'}, {'name': 'Nikhil Yawalkar, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inselspital - Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Michel Gilliet, Prof.', 'role': 'CONTACT', 'email': 'michel.gilliet@chuv.ch'}, {'name': 'Curdin Conrad, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Vaudois (CHUV)', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Antonio Cozzio, Prof.', 'role': 'CONTACT', 'email': 'Antonio.Cozzio@kssg.ch'}, {'name': 'Antonio Cozzio, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Gallen Cantonal Hospital', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': 'CH-8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Tatjana Maul, PD Dr.', 'role': 'CONTACT', 'email': 'Julia-Tatjana.Maul@usz.ch'}, {'name': 'Tatjana Maul, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zurich University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Alexander Navarini, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Society of Dermatology and Venereology (SSDV)'}, {'name': 'Julia-Tatjana Maul, PD Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Society of Dermatology and Venereology (SSDV)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Dermatology Network for Targeted Therapies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}