Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-29 @ 2:11 PM
Study NCT ID:
NCT02401620
Status:
UNKNOWN
Last Update Posted:
2015-03-30
First Post:
2015-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Tolerability Questionnaire in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2015-03-19', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective.", 'timeFrame': '10 months', 'description': 'To validate (evaluate measurement properties) a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in routine clinical practice'}], 'secondaryOutcomes': [{'measure': 'the feasibility of the questionnaire by non-response rate and the time required to complete it', 'timeFrame': '10 months', 'description': 'To assess the feasibility of the questionnaire by non-response rate and the time required to complete it'}, {'measure': 'the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).', 'timeFrame': '10 months', 'description': 'To assess the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity'}, {'measure': 'the reliability of the questionnaire in terms of internal consistency', 'timeFrame': '10 months', 'description': 'To assess the reliability of the questionnaire in terms of internal consistency'}, {'measure': 'describe socio-demographic and clinical features of the patients recruited in the study.', 'timeFrame': '10 months', 'description': 'To describe socio-demographic and clinical features of the patients recruited in the study.'}, {'measure': 'the adverse reactions (AR) reported by patients impact in the daily life.', 'timeFrame': '10 months', 'description': 'To assess the adverse reactions (AR) reported by patients impact in the daily life'}, {'measure': 'correlation between the tolerability questionnaire and the patient satisfaction', 'timeFrame': '10 months', 'description': 'To assess the correlation between the tolerability questionnaire and the patient satisfaction (ARTS questionnaire)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AR: arthritis rheumatoid', 'DMARDs: Disease-modifying antirheumatic drugs', 'ACR. American College of Rheumatology', 'EULAR: European League against rheumatology'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "The purpose of the present study is to assess the measurement properties of a tolerability questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated will be robust and will assess the patient's tolerability to the treatment. Patients with greater tolerability will be more satisfied with their treatment.", 'detailedDescription': "Clinicians do not have any standardized questionnaire to assess the tolerability from the patient's perspective. The tolerability assessment of the different pharmacological strategies for Rheumatoid Arthritis, from the patient's perspective, would provide additional information, improve doctor-patient communication and improve both adherence to and efficacy of treatment. For these reasons, the development and validation of a new tool is necessary not only for future researches, but for use in standard clinical practice.\n\nThe first phase of the development of the questionnaire has already been completed. The second phase of the development of the questionnaire has been designed at to validate the tool in the Spanish population.\n\nThis study aims to assess the measurement properties of a new tool which assesses the impact of daily life in Rheumatoid Arthritis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Rheumatoid Arthritis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients over 18 years old.\n2. Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010\n3. Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study \\*\n4. Patients who have provided informed consent prior to taking part in the study.\n\n * It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.\n\nExclusion Criteria:\n\n1. Patients with rheumatic disease other than Rheumatoid Arthritis. Will be exclude patients with the following concomitant diseases: Rheumatic autoimmune disease other than RA; Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis; Diagnosis of juvenile idiopathic arthritis; inflammatory joint disease other than Rheumatoid Arthritis.\n2. Patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization.\n3. Patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions.\n4. Patients who participated in interviews of the Phase I (development of the questionnaire)"}, 'identificationModule': {'nctId': 'NCT02401620', 'briefTitle': 'Validation of a Tolerability Questionnaire in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'FUN-TOC-2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single-group studies', 'description': 'Patients with RA diagnosed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raimón Sanmartí', 'role': 'CONTACT'}, {'name': 'Raimón Sanmartí', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08970', 'city': 'Sant Joan Despí', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Hector Coromines', 'role': 'CONTACT'}, {'name': 'Hector Coromines', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Moisés Broggi', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'zip': '07800', 'city': 'Ibiza Town', 'state': 'Ibiza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Urruticoechea', 'role': 'CONTACT'}, {'name': 'Ana Urruticoechea', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Can Misses', 'geoPoint': {'lat': 38.90883, 'lon': 1.43296}}, {'zip': '07010', 'city': 'Mallorca', 'state': 'Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lluis Espadaler', 'role': 'CONTACT'}, {'name': 'Lluis Espadaler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Son Espases'}, {'zip': '07198', 'city': 'Mallorca', 'state': 'Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Inmaculada Ros', 'role': 'CONTACT'}, {'name': 'Inmaculada Ros', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Son Llàtzer'}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antoni Gomez Centeno', 'role': 'CONTACT'}, {'name': 'Antoni Gomez Centeno', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Antoni Gomez Centeno, MD', 'role': 'CONTACT', 'email': 'msarmiento@es.imshealth.com', 'phone': '0034937496300', 'phoneExt': '6371'}, {'name': 'Monica Sarmiento', 'role': 'CONTACT', 'email': 'msarmiento@es.imshealth.com', 'phone': '0034937496300', 'phoneExt': '6371'}], 'overallOfficials': [{'name': 'Antoni Gomez Centeno', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Corporacio Parc Tauli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antonio D Gómez-Centeno', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}