Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-24 @ 5:01 AM
Study NCT ID:
NCT02008266
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2013-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Treatment of Algerian Patients With Early 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 532}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-06', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression.", 'timeFrame': 'Single observational visit [Day 1]'}], 'secondaryOutcomes': [{'measure': 'Measure disease activity using DAS 28 assessment.', 'timeFrame': 'Single observational visit [Day 1]'}, {'measure': 'Assess joint damage using the modified SHARP method.', 'timeFrame': 'Single observational visit [Day 1]'}, {'measure': 'Assess functional status of patients using the Health Assessment Questionnaire (HAQ).', 'timeFrame': 'Single observational visit [Day 1]'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Rheumatoid Arthritis that has been progressing for \\> 3 months and \\< 2 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis progressing for \\< 2 years.\n\nExclusion Criteria:\n\n* Rheumatoid arthritis progressing for \\< 3 months.\n* Rheumatoid arthritis onset at \\< 18 years of age.\n* Participation in another clinical study.\n* Rheumatoid arthritis related connective tissue disorder.\n* Any neuropsychological disorders.'}, 'identificationModule': {'nctId': 'NCT02008266', 'briefTitle': 'Study of the Treatment of Algerian Patients With Early Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Case Study of the Treatment of Early Rheumatoid Arthritis in Algerian Patients in Both the Private and Public Healthcare Sectors.', 'orgStudyIdInfo': {'id': 'ML25384'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Rheumatoid Arthritis'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}