Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT03264703
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2017-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D018771', 'term': 'Arthralgia'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6', 'timeFrame': 'Baseline; Month 6', 'description': 'DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the DAS28-ESR at Month 3', 'timeFrame': 'Baseline; Month 3', 'description': 'DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.'}, {'measure': 'Change from Baseline in the DAS28-ESR at Month 12', 'timeFrame': 'Baseline; Month 12', 'description': 'DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.'}, {'measure': 'Clinical remission rate measured by DAS28-ESR', 'timeFrame': 'Up to 12 months', 'description': 'Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.'}, {'measure': 'Success rates of dose-reduction and discontinuation of steroid(s)', 'timeFrame': 'Up to 12 months', 'description': 'Dose reduction is defined as a reduction by more than 50% compared to baseline.'}, {'measure': 'Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life', 'timeFrame': 'Up to 12 months', 'description': 'The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Joint pain', 'Joint stiffness', 'Joint redness', 'Loss of joint function', 'Swollen joints'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with rheumatoid arthritis within 3 years\n* Participants who have no experience with anti-tumor necrosis factor (anti-TNF)\n* Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent\n* Participants who change the treatment regimen to one of the following according to the opinion of the investigator:\n\n 1. One cDMARD plus anti-TNF\n 2. Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent\n\nExclusion Criteria:\n\n* Participants who may be pregnant or lactating women\n* Participants who have contraindication to anti-TNF\n* Participants who had participated in this study'}, 'identificationModule': {'nctId': 'NCT03264703', 'acronym': 'HUMAN', 'briefTitle': 'Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]', 'orgStudyIdInfo': {'id': 'D2E7-M082-601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with RA with cDMARD, but no anti-TNF experience', 'description': 'Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ilsan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 1'}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 1', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 2', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 3', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 4', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 1', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 2', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 1', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 2', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 3', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 4', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 5', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 6', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 7', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Trial Site # 8', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Korea Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}