Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-26 @ 6:35 PM
Study NCT ID:
NCT01667458
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16', 'timeFrame': '16 months'}], 'secondaryOutcomes': [{'measure': 'Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue', 'timeFrame': '16 months'}, {'measure': 'Disease Activity Score DAS28', 'timeFrame': '16 months'}, {'measure': 'Pain: Visual Analogue Scale VAS Pain', 'timeFrame': '16 months'}, {'measure': 'Functional disability: Health Assessment Questionnaire HAQ', 'timeFrame': '16 months'}, {'measure': 'Quality of sleep: VAS', 'timeFrame': '16 months'}, {'measure': 'Anemia: Haemoglobin levels', 'timeFrame': '16 months'}, {'measure': 'Depression: Beck Depression Inventory (BDI) questionnaire', 'timeFrame': '16 months'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26344671', 'type': 'DERIVED', 'citation': 'Gossec L, Steinberg G, Rouanet S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe rheumatoid arthritis with an inadequate response to at least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment with RoActemra/Actemra', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Moderate to severe active rheumatoid arthritis, defined as DAS28 \\>/= 3.7\n* Inadequate clinical response to current treatment with \\>/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for \\>/= 3 months, or inadequate clinical response to anti-TNF therapy\n* Eligible for RoActemra/Actemra treatment in daily clinical practice\n* Absence of evolutive tuberculosis (TB)\n\nExclusion Criteria:\n\n* Hypersensitivity to tocilizumab or any of the excipients\n* Active, severe infections\n* Pregnant or lactating women\n* Participation in any other interventional study\n* Patients with major depression'}, 'identificationModule': {'nctId': 'NCT01667458', 'briefTitle': 'An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice', 'orgStudyIdInfo': {'id': 'ML25702'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '8310', 'city': 'Assebroek', 'country': 'Belgium', 'geoPoint': {'lat': 51.19367, 'lon': 3.2623}}, {'zip': '7800', 'city': 'Ath', 'country': 'Belgium', 'geoPoint': {'lat': 50.62937, 'lon': 3.77801}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '5500', 'city': 'Dinant', 'country': 'Belgium', 'geoPoint': {'lat': 50.25807, 'lon': 4.91166}}, {'zip': '6000', 'city': 'Gilly (Charleroi)', 'country': 'Belgium', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '2500', 'city': 'Lier', 'country': 'Belgium', 'geoPoint': {'lat': 51.13128, 'lon': 4.57041}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '4100', 'city': 'Seraing', 'country': 'Belgium', 'geoPoint': {'lat': 50.58362, 'lon': 5.50115}}, {'zip': '8340', 'city': 'Sijsele', 'country': 'Belgium', 'geoPoint': {'lat': 51.20846, 'lon': 3.31714}}, {'zip': '2300', 'city': 'Turnhout', 'country': 'Belgium', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'zip': '4800', 'city': 'Verviers', 'country': 'Belgium', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'zip': '4300', 'city': 'Waremme', 'country': 'Belgium', 'geoPoint': {'lat': 50.6976, 'lon': 5.25524}}, {'zip': '2390', 'city': 'Westmalle', 'country': 'Belgium', 'geoPoint': {'lat': 51.29767, 'lon': 4.69013}}, {'zip': '2763', 'city': 'Luxembourg', 'country': 'Luxembourg', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}