Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01139918
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2010-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'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'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-23', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'There is no primary outcome in this study. See objectives.', 'timeFrame': '1 Day', 'description': 'There is no primary outcome in this study. Patients with psoriatic arthritis and psoriasis answer questionnaires on one occasion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psoriatic arthritis', 'psoriasis', 'Quality of life'], 'conditions': ['Psoriatic Arthritis', 'Psoriasis']}, 'descriptionModule': {'briefSummary': "This exploratory study will be used to identify questions that will be part of a new QoL questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample size needed for its validation. The new questionnaire will be a global QoL questionnaire which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.\n\nSTUDY OBJECTIVES\n\n* To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.\n* To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36 where answers are mostly influenced either by psoriatic arthritis or by psoriasis.", 'detailedDescription': 'This study will recruit three cohorts of 40 patients each: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis, moderate psoriatic arthritis and mild psoriasis. Eligible patients will fill the following questionnaires: Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ), EQ-5D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) and 36-Item Short Form Health Survey Questionnaire (SF-36). In addition, each patient will be asked on a 4 point Likert scale how much their answer to each question is related to the impact of their skin disease or their psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study popululation description: Patients suffering from either: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis or moderate psoriatic arthritis and mild psoriasis, known from dermatologists participating in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with plaque psoriasis and psoriatic arthritis with either:\n\n * Moderate psoriatic arthritis and moderate psoriasis defined as: \\[psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4\\] AND \\[between 3 to less than 10% of the body surface area involved with psoriasis\\] (COHORT A) OR\n * Mild psoriatic arthritis and Moderate psoriasis defined as: \\[psoriatic arthritis with either 1-2 joints showing signs of synovitis OR a BASDAI greater than 0 but less than 2\\] AND \\[between 3 to less than 10% of the body surface area involved with psoriasis\\] (COHORT B) OR\n * Moderate psoriatic arthritis and Mild psoriasis defined as: \\[psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4\\] AND \\[more than 0 but less than 3% of the body surface area involved with psoriasis\\] (COHORT C)\n* Patient is between 18 years and older.\n* Patient is capable of reading and understanding French or English questionnaires.\n* Patient is capable of giving informed consent.\n\nExclusion Criteria:\n\n* Patient has presence of eythrodermic, pustular or guttate psoriasis.\n* Patient has another non psoriatic arthropathy (such as osteoarthritis) that could have a significant impact of QoL related to psoriatic arthritis\n* Patient has another non psoriatic dermatosis that could have a significant impact on QoL related to psoriasis\n* Patient has any other co-morbidity with a severity that could have a significant impact on QoL\n* Patient has had a significant flare-up of psoriasis or psoriatic arthritis within 90 days of Day 0\n* Patient has received investigational drugs within four weeks prior to Day 0\n* Patient has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy within the four weeks prior to Day 0. Methotrexate, sulphasalazine and leflunomide are allowed during the study as long as patient has been on a stable dose within 90 days of Day 0.\n* Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0\n* Patient has used biologics (such etanercept, adalimumab, infliximab, abatacept, ustekinumab) within 180 days of Day 0\n* Patient is currently pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT01139918', 'briefTitle': 'Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Innovaderm Research Inc.'}, 'officialTitle': 'Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'Inno-6017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': '40 patients with moderate psoriatic arthritis and moderate psoriasis'}, {'label': 'Cohort B', 'description': '40 patients with mild psoriatic arthritis and moderate psoriasis'}, {'label': 'Cohort C', 'description': '40 patients with moderate psoriatic arthritis and mild psoriasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2S3B3', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Kirk Barber Research', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'R3C 0N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Winnipeg Clinic Dermatology Research', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1A 5E8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Nexus Clinical Research', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L8N 1V6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermatrials Research', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L3P 1A8', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynderm Research Inc.', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'N8W 5L7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Clinical Research Inc.', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H2K 4L5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Innovaderm Research Inc.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4X7', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Dermatologique du Quebec Metropolitain', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J2S 6L6', 'city': 'Saint-Hyacinthe', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Médicale Dr Isabelle Delorme', 'geoPoint': {'lat': 45.63076, 'lon': -72.95699}}, {'zip': 'J1H 1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Diex Research Sherbrooke east', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Robert Bissonnette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innovaderm Research Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovaderm Research Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}