Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
Study NCT ID:
NCT04174092
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2019-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Catastrophism in Chronic Inflammatory Rheumatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 533}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catastrophic assessment', 'timeFrame': 'Day 0', 'description': 'Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)'}, {'measure': 'catastrophic assessment', 'timeFrame': 'at 3 months', 'description': 'Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)'}, {'measure': 'catastrophic assessment', 'timeFrame': 'at 6 months', 'description': 'Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)'}, {'measure': 'catastrophic assessment', 'timeFrame': 'at 12 months', 'description': 'Pain Catastrophism Scale (0= no catastrophism, 52 = maximum catastrophism)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catastrophism'], 'conditions': ['Chronic Inflammatory Rheumatism']}, 'descriptionModule': {'briefSummary': 'Catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. It has three components: rumination, amplification and vulnerability. The assessment of catastrophism is carried out using a validated questionnaire called the "Pain Catatrophizing Scale" (PCS).\n\nRecent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. In these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). Several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic.\n\nIn chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patients, hospital follow-up, with RA according to ACR 2010 criteria, or spondyloarthritis according to ASAS 2009 criteria or according to AMOR or psoriatic arthritis according to Caspar 2006 criteria.\n* Patient who has given free and informed consent.\n* Patient who has signed the consent form.\n* Patient affiliated or benefiting from a health insurance plan.\n* Adult patient (≥18 years old).\n\nExclusion Criteria:\n\n* Patient under the protection of justice, under guardianship or curatorship.\n* Patient unable to express consent.\n* Patient for whom it is impossible to provide informed information.\n* Poor command and understanding of the French language making it impossible to complete self-questionnaires'}, 'identificationModule': {'nctId': 'NCT04174092', 'acronym': 'CRIC', 'briefTitle': 'Catastrophism in Chronic Inflammatory Rheumatism', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Catastrophism in Chronic Inflammatory Rheumatism', 'orgStudyIdInfo': {'id': 'LOCAL 2019/CGV/01'}, 'secondaryIdInfos': [{'id': '2019.A01715-52', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rheumatoid arthritis', 'description': 'Filling in several self-questionnaires: on function (HAQ), pain EVA, quality of life (SF12, EQ5D), anxiety score (GAD-7), insomnia score (ISI), catastrophic score (PCS), coping score (coping ability, CSQ), compliance scores (CQR, Health Insurance Compliance Assessment Questionnaire) and fibromyalgia diagnostic score (FiRST), activity of rheumatic disease (RAID, RAPID-3) Patients will be seen at 3, 6 and 12 months', 'interventionNames': ['Other: completing self-questionnaires']}, {'type': 'EXPERIMENTAL', 'label': 'spondyloarthritis', 'description': 'Filling in several self-questionnaires: on function (HAQ), pain EVA, quality of life (SF12, EQ5D), anxiety score (GAD-7), insomnia score (ISI), catastrophic score (PCS), coping score (coping ability, CSQ), compliance scores (CQR, Health Insurance Compliance Assessment Questionnaire) and fibromyalgia diagnostic score (FiRST), activity of rheumatic disease (BASDAI, BASFI).\n\nPatients will be seen at 3, 6 and 12 months', 'interventionNames': ['Other: completing self-questionnaires']}, {'type': 'EXPERIMENTAL', 'label': 'Psoriatic arthritis', 'description': 'Filling in several self-questionnaires: on function (HAQ), pain EVA, quality of life (SF12, EQ5D), anxiety score (GAD-7), insomnia score (ISI), catastrophic score (PCS), coping score (coping ability, CSQ), compliance scores (CQR, Health Insurance Compliance Assessment Questionnaire) and fibromyalgia diagnostic score (FiRST), activity of rheumatic disease (BASDAI, BASFI).\n\nPatients will be seen at 3, 6 and 12 months', 'interventionNames': ['Other: completing self-questionnaires']}], 'interventions': [{'name': 'completing self-questionnaires', 'type': 'OTHER', 'description': 'completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism', 'armGroupLabels': ['Psoriatic arthritis', 'rheumatoid arthritis', 'spondyloarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34 295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Anissa MEGZARI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}