Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-28 @ 11:42 PM
Study NCT ID:
NCT01918267
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)
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': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-06', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Disease Activity Score (DAS28)', 'timeFrame': 'from baseline to Month 36'}], 'secondaryOutcomes': [{'measure': 'Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)', 'timeFrame': 'from baseline to Month 36'}, {'measure': 'Measure of progressive joint destruction (vdHSS)', 'timeFrame': 'from baseline of U-Act-Early to Month 24 of U-Act-After'}, {'measure': 'Changes in concomitant medication (especially tapering of corticosteroids)', 'timeFrame': 'from baseline to Months 36'}, {'measure': 'Sustained remission rates/drug-free remission rates', 'timeFrame': '36 months'}, {'measure': 'Dose modifications/interruptions of RA treatment', 'timeFrame': '36 months'}, {'measure': 'Safety: Incidence of adverse events, adverse events of special interest and serious adverse events', 'timeFrame': '36 months'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who participated in the U Act Early study (ML22497)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have participated in the U-Act-Early trial (ML22497); these are adult patients (\\> 20 years of age) with rheumatoid arthritis.\n* Patients must be willing to give written informed consent\n\nExclusion Criteria:\n\n* Patients who did not participate in the U-Act-Early trial\n* Patients who are drop-outs in the U-Act-Early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators'}, 'identificationModule': {'nctId': 'NCT01918267', 'briefTitle': 'U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'ML28388'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1815 JD', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medisch Centrum Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '3818 ES', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medisch Centrum; Locatie Lichtenberg', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '7334 DZ', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '4819 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '4204 AA', 'city': 'Gorinchem', 'country': 'Netherlands', 'facility': 'Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie', 'geoPoint': {'lat': 51.83652, 'lon': 4.97243}}, {'zip': '2803 HH', 'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Groene Hart Ziekenhuis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen; Department of Rheumatology', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2035RC', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Atrium Medisch Centrum; Nephrology', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '1213 HX', 'city': 'Hilversum', 'country': 'Netherlands', 'facility': 'Tergooiziekenhuizen, loc. Hilversum', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'zip': '2134 TM', 'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Spaarne Ziekenhuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medisch Centrum Leeuwarden; Reumatology', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Leiden; Dept of Rheumatology', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '8233 AA', 'city': 'Lelystad', 'country': 'Netherlands', 'facility': 'Ijsselmeer Ziekenhuizen; Interne Geneeskunde', 'geoPoint': {'lat': 52.50833, 'lon': 5.475}}, {'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis Nieuwegein', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '6522 JV', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'St. Maartenskliniek', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '8601 ZK', 'city': 'Sneek', 'country': 'Netherlands', 'facility': 'Antonius Ziekenhuis Sneek; Department of Rheumatology', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '3584 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Centre Utrecht; Reumatologie en Klinische Immunologie', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '3447 GN', 'city': 'Woerden', 'country': 'Netherlands', 'facility': 'Maartenskliniek Woerden', 'geoPoint': {'lat': 52.085, 'lon': 4.88333}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}