Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-01 @ 3:23 PM
Study NCT ID:
NCT01077232
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction.', 'timeFrame': 'At 24, 48 and 60 months'}, {'measure': "Changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability.", 'timeFrame': 'At 24, 48 and 60 months'}, {'measure': 'Safety and tolerability assessed by analyzing serious and non-serous adverse events.', 'timeFrame': 'At 24, 48 and 60 months'}], 'secondaryOutcomes': [{'measure': "Global physician's assessment on Humira treatment.", 'timeFrame': 'At 24, 48 and 60 months'}, {'measure': 'Target Nail Psoriasis Severity Index (target NAPSI).', 'timeFrame': 'At 24 months'}, {'measure': 'Itch Visual Analogue Scale (Itch VAS).', 'timeFrame': 'At 24 months'}, {'measure': 'Safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication.', 'timeFrame': 'At 24, 48 and 60 months'}, {'measure': 'Palmoplantar Psoriasis Area Severity Index (pPASI).', 'timeFrame': 'At 24 months'}, {'measure': 'Influence of body mass index and weight on efficacy measurement.', 'timeFrame': 'At 24, 48 and 60 months'}, {'measure': "Patients' assessment on Humira treatment.", 'timeFrame': 'At 24, 48 and 60 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate to Severe Plaque Psoriasis', 'Humira', 'Safety', 'Efficacy', 'Work Productivity'], 'conditions': ['Moderate to Severe Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.', 'detailedDescription': "Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice. The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:\n\n* the number of missed working days\n* the number of visits to doctor's office\n* the number and duration of hospitalizations\n* work ability to assess efficacy for different subgroups by\n* the number of patients achieving a PASI 75 response to evaluate safety by\n* the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community Sample: Patients with Plaque Psoriasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Moderate to severe plaque psoriasis in adults with no response to other systemic therapy (e.g. cyclosporine, methotrexate or PUVA (photochemical therapy)) or patients with a contraindication or hypersensitivity to such a therapy\n\nExclusion Criteria:\n\n\\- Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency'}, 'identificationModule': {'nctId': 'NCT01077232', 'acronym': 'LOTOS', 'briefTitle': 'Documentation of Humira in Psoriasis Patients in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)', 'orgStudyIdInfo': {'id': 'P10-446'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psoriasis Patients', 'description': 'Patients with moderate to severe plaque psoriasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitaetsklinik Heidelberg /ID# 33810', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitaetsklinik Heidelberg /ID# 50858', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitatsklinikum Mannheim /ID# 166130', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitaetsklinikum Erlangen /ID# 34816', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt /ID# 53725', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '48149', 'city': 'Munster', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Universitatsklinikum Munster /ID# 205840', 'geoPoint': {'lat': 52.98569, 'lon': 10.08756}}, {'zip': '48149', 'city': 'Munster', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Universitatsklinikum Munster /ID# 72018', 'geoPoint': {'lat': 52.98569, 'lon': 10.08756}}, {'zip': '48149', 'city': 'Munster', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Universitatsklinikum Munster /ID# 72022', 'geoPoint': {'lat': 52.98569, 'lon': 10.08756}}, {'zip': '52062', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Praxis M. Vilic /ID# 210108', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitaetsklinikum Aachen /ID# 35037', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Uniklinik Koln /ID# 166128', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '48147', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Hautarztpraxis am Buddenturm /ID# 205094', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Praxis Dr. Büchner /ID# 204352', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitaetsklinikum Leipzig /ID# 53720', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '01796', 'city': 'Pirna', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Praxis Dr. Reimann /ID# 142004', 'geoPoint': {'lat': 50.95843, 'lon': 13.93702}}, {'zip': '24103', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Praxis N. Yenigün /ID# 206670', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Univ Hosp Schleswig-Holstein /ID# 33981', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Univ Hosp Schleswig-Holstein /ID# 35269', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '24148', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Medizinisches Versorgungszentrum DermaKiel GmbH /ID# 33972', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '52064', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Hoeller-Obrigkeit, Aachen, DE /ID# 60599', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '48683', 'city': 'Ahaus', 'country': 'Germany', 'facility': 'Petri, Ahaus, DE /ID# 53712', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'zip': '22926', 'city': 'Ahrensburg', 'country': 'Germany', 'facility': 'Gewiss, Ahrensburg, DE /ID# 33431', 'geoPoint': {'lat': 53.67661, 'lon': 10.23705}}, {'zip': '36304', 'city': 'Alsfeld', 'country': 'Germany', 'facility': 'Praxis Dr. Schuessler /ID# 149404', 'geoPoint': {'lat': 50.75185, 'lon': 9.27082}}, {'zip': '57610', 'city': 'Altenkirchen', 'country': 'Germany', 'facility': 'Oster-Schmidt, Altenkirchen, D /ID# 126022', 'geoPoint': {'lat': 50.68594, 'lon': 7.64176}}, {'zip': '92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Weiss, Amberg, DE /ID# 60613', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '84539', 'city': 'Ampfing', 'country': 'Germany', 'facility': 'Dietz, Ampfing, DE /ID# 50790', 'geoPoint': {'lat': 48.254, 'lon': 12.41515}}, {'zip': '56626', 'city': 'Andernach', 'country': 'Germany', 'facility': 'Bell, Andernach, DE /ID# 99815', 'geoPoint': {'lat': 50.43109, 'lon': 7.40425}}, {'zip': '16278', 'city': 'Angermünde', 'country': 'Germany', 'facility': 'Schulz, Angermuende, DE /ID# 53719', 'geoPoint': {'lat': 53.01499, 'lon': 13.99924}}, {'zip': '9456', 'city': 'Annaberg-Buchholz', 'country': 'Germany', 'facility': 'Rebbien, Annaberg-Buchholz, DE /ID# 35052', 'geoPoint': {'lat': 50.57953, 'lon': 13.00627}}, {'zip': '06556', 'city': 'Artern', 'country': 'Germany', 'facility': 'Thieme, Artern, DE /ID# 35518', 'geoPoint': {'lat': 51.36431, 'lon': 11.29167}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Dr. Szlava Fuezesi, Achaffenbu /ID# 118537', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '06449', 'city': 'Aschersleben', 'country': 'Germany', 'facility': 'Theuring, Aschersleben, DE /ID# 35058', 'geoPoint': {'lat': 51.75742, 'lon': 11.46084}}, {'zip': '08280', 'city': 'Aue', 'country': 'Germany', 'facility': 'Hums, Aue, DE /ID# 60601', 'geoPoint': {'lat': 50.59034, 'lon': 12.70657}}, {'zip': '8280', 'city': 'Aue', 'country': 'Germany', 'facility': 'Gerloff-Steiner, Aue, DE /ID# 53694', 'geoPoint': {'lat': 50.59034, 'lon': 12.70657}}, {'zip': '86167', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Schneider & Sedlmayr, Augsburg /ID# 33351', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '26603', 'city': 'Aurich', 'country': 'Germany', 'facility': 'Lechner/Stuebich, Aurich, DE /ID# 33355', 'geoPoint': {'lat': 53.46963, 'lon': 7.48239}}, {'zip': '26603', 'city': 'Aurich', 'country': 'Germany', 'facility': 'Lechner/Stuebich, Aurich, DE /ID# 67967', 'geoPoint': {'lat': 53.46963, 'lon': 7.48239}}, {'zip': '99438', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Brautzsch, Bad Berka, DE /ID# 33365', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '19209', 'city': 'Bad Doberan', 'country': 'Germany', 'facility': 'Broschewitz/Hammer Bad Doberan /ID# 60596', 'geoPoint': {'lat': 54.10712, 'lon': 11.90051}}, {'zip': '19209', 'city': 'Bad Doberan', 'country': 'Germany', 'facility': 'Broschewitz/Hammer Bad Doberan /ID# 67948', 'geoPoint': {'lat': 54.10712, 'lon': 11.90051}}, {'zip': '55543', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Mauer, Bad Kreuznach, DE /ID# 126019', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, {'zip': '31848', 'city': 'Bad Münder am Deister', 'country': 'Germany', 'facility': 'Schulz, Bad Muender, DE /ID# 48469', 'geoPoint': {'lat': 52.19551, 'lon': 9.46421}}, {'zip': '83435', 'city': 'Bad Reichenhall', 'country': 'Germany', 'facility': 'SALUS-Klinik /ID# 33405', 'geoPoint': {'lat': 47.72947, 'lon': 12.87819}}, {'zip': '49214', 'city': 'Bad Rothenfelde', 'country': 'Germany', 'facility': 'Praxis Dr. Bock /ID# 166127', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'zip': '8301', 'city': 'Bad Schlema', 'country': 'Germany', 'facility': 'Houda, Bad Schlema, DE /ID# 35584', 'geoPoint': {'lat': 50.60257, 'lon': 12.67288}}, {'zip': '86825', 'city': 'Bad Wörishofen', 'country': 'Germany', 'facility': 'Moerstedt, Bad Woerishofen, DE /ID# 99844', 'geoPoint': {'lat': 48.00674, 'lon': 10.59666}}, {'zip': '96049', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Sozialstiftung Bamberg /ID# 33430', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '22941', 'city': 'Bargteheide', 'country': 'Germany', 'facility': 'Stephan-Dahm, Bargteheide, DE /ID# 50861', 'geoPoint': {'lat': 53.72989, 'lon': 10.26739}}, {'zip': '34225', 'city': 'Baunatal', 'country': 'Germany', 'facility': 'Dr. Roxana Homolka, Baunatal, /ID# 118539', 'geoPoint': {'lat': 51.25182, 'lon': 9.40747}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Mirtschink, Bautzen, DE /ID# 50851', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '95444', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Graessel, Bayreuth, DE /ID# 35587', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '95444', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Kinateder, Bayreuth, DE /ID# 33439', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '56170', 'city': 'Bendorf', 'country': 'Germany', 'facility': 'Blaese & Walther, Bendorf, DE /ID# 50787', 'geoPoint': {'lat': 50.42289, 'lon': 7.57924}}, {'zip': '56170', 'city': 'Benndorf', 'country': 'Germany', 'facility': 'Pflieger-Bruss, Benndorf, DE /ID# 53713', 'geoPoint': {'lat': 51.57035, 'lon': 11.4929}}, {'zip': '18528', 'city': 'Bergen', 'country': 'Germany', 'facility': 'Timmel/Timm/Vorwerk, Bergen /ID# 33451', 'geoPoint': {'lat': 52.80837, 'lon': 9.96374}}, {'zip': '51465', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Wirtler, Bergisch Gladbach, DE /ID# 33452', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Campus Mitte /ID# 33457', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Hasert & Hasert, Berlin, DE /ID# 35531', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Kindler, Berlin, Germany /ID# 60604', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klusmann, Berlin, DE /ID# 90974', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10247', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Spickermann, Berlin, DE /ID# 33675', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10623', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dermatologie am Savigny /ID# 145783', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10627', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Herzler & Reupke, Berlin, DE /ID# 33705', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10783', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Boodstein, Berlin, Germany /ID# 48417', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10783', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Rothhaar, Berlin, DE /ID# 33644', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10827', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Simon, Berlin, DE /ID# 33678', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10827', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Steinhoff-Georgieva, Berlin,DE /ID# 60612', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10967', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Struss, Berlin, DE /ID# 33680', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12157', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Miller/Nerenheim, Berlin, DE /ID# 99842', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12159', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr. med. 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