Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT02234960
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2014-09-05', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment', 'timeFrame': 'Month 6'}, {'measure': 'Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment', 'timeFrame': 'Month 6'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time', 'timeFrame': 'Baseline up to Month 6'}, {'measure': 'Time to Discontinuation', 'timeFrame': 'Baseline up to Month 6'}, {'measure': 'Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate', 'timeFrame': 'Baseline up to Month 6'}, {'measure': 'Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline', 'timeFrame': 'Baseline'}, {'measure': 'Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment', 'timeFrame': 'Month 3'}, {'measure': 'Change From Baseline in DAS28 Over Time', 'timeFrame': 'Baseline up to Month 6'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) Over Time', 'timeFrame': 'Baseline up to Month 6'}, {'measure': 'Percentage of Participants With Discontinuations Due to Lack of Efficacy', 'timeFrame': 'Baseline up to Month 6'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)', 'timeFrame': 'Baseline up to Month 6'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active RA who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland. The length of the entire study will be 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a diagnosis of moderate to severe RA who are inadequate responders to DMARDs, or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants at least 18 years of age\n* a diagnosis of moderate to severe RA\n* treating physician has made the decision to commence tocilizumab in first line biologic treatment (population of DMARDs inadequate responders or participants who are intolerant to DMARDs) in a routine clinical practice in Poland\n* informed consent\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02234960', 'briefTitle': 'Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)', 'orgStudyIdInfo': {'id': 'ML29444'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort of RA Participants', 'description': 'Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months.', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'description': 'Tocilizumab will be given according to summary of product characteristics as per clinical practice.', 'armGroupLabels': ['Cohort of RA Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-681', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'zip': '63-100', 'city': 'Gmina Śrem', 'country': 'Poland', 'geoPoint': {'lat': 52.08868, 'lon': 17.01508}}, {'zip': '30-119', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-954', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '10-045', 'city': 'Olsztyn', 'country': 'Poland', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '61-285', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '98-200', 'city': 'Sieradz', 'country': 'Poland', 'geoPoint': {'lat': 51.59584, 'lon': 18.73023}}, {'zip': '81-759', 'city': 'Sopot', 'country': 'Poland', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '27-200', 'city': 'Starachowice', 'country': 'Poland', 'geoPoint': {'lat': 51.0374, 'lon': 21.07126}}, {'zip': '34-200', 'city': 'Sucha Beskidzka', 'country': 'Poland', 'geoPoint': {'lat': 49.74188, 'lon': 19.59429}}, {'zip': '43-450', 'city': 'Ustroń', 'country': 'Poland', 'geoPoint': {'lat': 49.72153, 'lon': 18.80198}}, {'zip': '50-981', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}