Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 1:23 PM
Study NCT ID:
NCT04170504
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS', 'timeFrame': 'week 0, week 24', 'description': 'Bone marrow edema score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 75; higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS', 'timeFrame': 'week 0, week 24', 'description': 'Bone erosion score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 250; higher scores mean a worse outcome.'}, {'measure': 'The proportion of participants with no progression in bone marrow edema and bone erosion', 'timeFrame': 'week 24', 'description': 'No progression in bone marrow edema and bone erosion at week 24 is defined as change in RAMRIS osteitis/erosion score ≤0.'}, {'measure': 'The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)', 'timeFrame': 'week 4, week 12, week 24', 'description': 'The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)'}, {'measure': 'Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate', 'timeFrame': 'week 0, week 4, week 12, week 24', 'description': 'The improvement of DAS28-ESR and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as DAS28-ESR \\<2.6.'}, {'measure': 'Change in Clinical Disease Activity Index (CDAI)', 'timeFrame': 'week0, week4, week 12, week 24', 'description': 'The improvement of CDAI and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as CDAI \\<2.8.'}, {'measure': 'Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA)', 'timeFrame': 'week0, week 4, week 12, week 24', 'description': 'CPRI-RA,The self-rating scale consists of 11 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.'}, {'measure': 'Change in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'week0, week4, week 12, week 24', 'description': 'The self-rating scale consists of 20 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively. (range: 0 \\[best\\] to 3 \\[worst\\])'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Qing Re Huo Xue', 'Methotrexate', 'Randomized controlled trial'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized, double-blinded, placebo-controlled trial with two parallel arms. The aim of the study is to evaluate whether Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than Qing Re Huo Xue placebo combined with MTX for patients with active rheumatoid arthritis (RA).', 'detailedDescription': 'To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10g bid and MTX 10mg once a week for 24 weeks, or MTX plus QRHX placebo. The primary outcome is the bone marrow edema score in Outcome Measures in Rheumatology Clinical Trials RA MRI Scoring (OMERACT-RAMRIS) at week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.\n2. Subject has a DAS28 CRP disease activity score of \\>3.2 at screening.\n3. Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.\n4. Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.\n5. Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.\n\nExclusion Criteria:\n\n1. History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.\n2. Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.\n3. Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.\n4. Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT04170504', 'briefTitle': 'Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018YFC1705203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)', 'description': 'QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks', 'interventionNames': ['Drug: Qing Re Huo Xue (QRHX) granule', 'Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)', 'description': 'QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks', 'interventionNames': ['Drug: Methotrexate', 'Drug: Qing Re Huo Xue (QRHX) granule placebo']}], 'interventions': [{'name': 'Qing Re Huo Xue (QRHX) granule', 'type': 'DRUG', 'description': 'Qing Re Huo Xue (QRHX) granule 10g bid for 24 weeks', 'armGroupLabels': ['Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['XINYI Pharm'], 'description': 'Oral methotrexate 10 mg per week for 24 weeks.', 'armGroupLabels': ['Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)', 'Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)']}, {'name': 'Qing Re Huo Xue (QRHX) granule placebo', 'type': 'DRUG', 'description': 'Qing Re Huo Xue (QRHX) granule placebo 10g bid for 24 weeks', 'armGroupLabels': ['Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'country': 'China', 'facility': "Guang'anmen Hospital, China Academy of Chinese Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Quan Jiang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guang' anmen hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Quan Jiang', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}