Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 8:51 PM
Study NCT ID:
NCT02652494
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Apremilast in Patients With Psoriasis in The Netherlands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'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': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points', 'timeFrame': 'Up to approximately 12 months', 'description': 'The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.'}, {'measure': 'Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points', 'timeFrame': 'Up to approximately 12 months', 'description': 'The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.'}], 'secondaryOutcomes': [{'measure': 'Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment', 'timeFrame': 'Up to approximately 12 months', 'description': 'The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.'}, {'measure': 'Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey', 'timeFrame': 'Up to approximately 12 months', 'description': "The SF-36v2® Health Survey measures functional health and well-being from the patient's point of view. It can be used across age (18 and older), disease, and treatment group."}, {'measure': 'Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)', 'timeFrame': 'Up to approximately 12 months', 'description': 'EQ-5D is a standardized instrument for use as a measure of health outcome in a wide range of health conditions and treatment'}, {'measure': 'Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)', 'timeFrame': 'Up to approximately 12 months', 'description': 'Itch VAS is a simple assessment of the itch severity using a visual analogue scale'}, {'measure': 'Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment', 'timeFrame': 'Up to approximately 2 months', 'description': 'PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and Severity Index).'}, {'measure': 'Changes in body surface area (BSA)at 6 and 12 months treatment', 'timeFrame': 'Up to approximately 12 months', 'description': 'BSA (Body Surface Area): severity is defined by how much of the body surface area is affected.'}, {'measure': 'Changes in static physician global assessment (sPGA) at 6 and 12 months treatment', 'timeFrame': 'Up to approximately 12 months', 'description': 'sPGA: assessment by physician to classify disease activity in a consistent manner'}, {'measure': 'Baseline characteristics of patients initiating apremilast treatment', 'timeFrame': 'Up to approximately 1 month', 'description': 'Characteristics at baseline of patient initiating apremilast treatment'}, {'measure': 'Reasons for discontinuation of apremilast', 'timeFrame': 'Up to approximately 12 months', 'description': 'Rate and reasons for discontinuation of apremilast within 12 months of start'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Observational', 'Apremilast', 'APRIL', 'Non-Interventional', 'The Netherlands'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '38402373', 'type': 'BACKGROUND', 'citation': 'van den Reek JMPA, van der Leest RJT, Thomas SE, Prevoo R, Plantenga ME, de Jong EMGJ. Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands. Adv Ther. 2024 Apr;41(4):1594-1605. doi: 10.1007/s12325-023-02759-9. Epub 2024 Feb 24.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'https://clinicaltrials.gov/ct2/show/NCT02652494?term=CC-10004-PSOR-014&rank=1', 'label': 'Expanded Access for CC-10004'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective, non-interventional, observational single arm study.\n\nTwo-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.', 'detailedDescription': 'Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.\n\nFollow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.\n\n* Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))\n* Patients will be asked to complete the following questionnaires:\n* DLQI\n* TSQM\n* EQ5D\n* SF36- Itch Visual Analog Scale (VAS)\n* WPAI Work Productivity and Activity Index\n* Patient Benefit Index PBI\n\nEnd of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.\n\nAE monitoring All patients will be monitored for adverse events throughout the study.\n\nFrom the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two hundred adult patients treated with apremilast for psoriasis in clinical practice. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.\n* Patients starting treatment for psoriasis with apremilast in clinical practice.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Women who are pregnant or breast-feeding.\n* Hypersensitivity to the active substance or to any of the excipients.\n* Prior exposure to apremilast\n* Psoriatic arthritis treated by a rheumatologist in the previous year'}, 'identificationModule': {'nctId': 'NCT02652494', 'acronym': 'APRIL', 'briefTitle': 'Observational Study of Apremilast in Patients With Psoriasis in The Netherlands', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands', 'orgStudyIdInfo': {'id': 'CC-10004-PSOR-014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving Apremilast per daily clinical practice', 'description': 'Dutch patients receiving Apremilast according to daily clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7555 DL', 'city': 'Hengelo', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Zorggroep Twente', 'geoPoint': {'lat': 52.05083, 'lon': 6.30972}}, {'zip': '6525 GL', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6162 BG', 'city': 'Sittard', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Zuyderland MC', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}, {'zip': '4624 VT', 'city': 'Bergen op Zoom', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Bravis Ziekenhuis', 'geoPoint': {'lat': 51.495, 'lon': 4.29167}}, {'zip': '4818 CK', 'city': 'Breda', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Amphia', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '5042 AD', 'city': 'Tilburg', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'TweeSteden Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '5504 DB', 'city': 'Veldhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Maxima MC', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '1817 MS', 'city': 'Alkmaar', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Centrum Oosterwal', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '2134 TM', 'city': 'Hoofddorp', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Spaarne Gasthuis', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '8601 DZ', 'city': 'Sneek', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Antonius Ziekenhuis Sneek', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '3079 DZ', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3813 TZ', 'city': 'Amsersfoort', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Meander MC'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}