Rheumatoid Arthritis
Conditions
Interventions
treatment group:MTX+ Modified Hua-yu Qiang-shen Tong-bi Decoction
Traditional Chinese Medicine Group:Modified Hua-yu Qiang-shen Tong-bi Decoction
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The study subjects should meet the following diagnostic criteria: ? Western medical diagnostic criteria: the 2010 ACR/EULAR classification criteria for RA was used for comprehensive judgment; ? According to the "Diagnostic Basis and Syndrome Classification of the Guidelines for the Combined Diagnosis and Treatment of Rheumatoid Arthritis" issued by the National Association of Traditional Chinese Medicine in 2019, the syndrome differentiation of traditional Chinese Medicine is cold-dampness syndrome and rheumatism syndrome; (2) patients with moderate to low disease activity according to DAS28-CRP score (2.6 < DAS28-CRP < 5.1); (3) aged 18-70 years old; (4) The X-ray classification of both hands was grade ? or below; (5) Subjects had to be taking no or a stable dose of oral methotrexate (12.5mg per week) for at least 4 weeks prior to screening and needed to maintain a stable dose throughout the study; 6) Other nonbiologic DMARDs: Leflunomide had to be discontinued 12 weeks before enrollment (although if standard cholestyramine washout was received for 11 days, leflunomide would need to be discontinued at least 4 weeks before starting study treatment). Any conventional DMARDs other than methotrexate and leflunomide (including sulfasalazine, azathioprine, hydroxychloroquine, iguratimod, cyclosporine, mycophenolate mofetil, tacrolimus, and so on) should be discontinued at least 4 weeks before enrollment; (7) If the participant had discontinued oral corticosteroids at least 2 weeks before enrollment; (8) If the subjects are using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics for RA, they must have been on a stable dose for at least 2 weeks before enrollment; If used but discontinued, nsaids had to be discontinued more than 2 weeks before enrollment; (9) Written informed consent to participate in the study signed by the subjects or their family members (guardians).
Exclusion criteria
Exclusion criteria: (1) patients with previous use of fusion protein biologics (including etanercept, Zyglinac, Amberino, Enli, etc.) and monoclonal antibody biologics (including adalimumab, infliximab, tocilizumab, etc.) with withdrawal less than 8 weeks before enrollment and withdrawal less than 12 weeks before enrollment; (2) patients who discontinued JAK inhibitors (including tofacitinib and baritinib) less than 2 weeks before enrollment; (3) patients who discontinued tripterygium wilfordii less than 12 weeks before study treatment, and were not allowed to use tripterygium wilfordii during the whole study; (4) patients had received interferon therapy within 4 weeks before enrollment or were expected to require interferon therapy during the study; (5) vaccinated with live vaccine within 2 weeks before enrollment, or required to be vaccinated with live vaccine during the study period; (6) patients received intra-articular, intramuscular, or intravenous glucocorticoids, including adrenocorticotropic hormone, within 12 weeks before enrollment; (7) pregnancy, lactation and recent childbearing plan; (8) patients with serious diseases of cardiovascular, brain, liver, lung, kidney and hematopoietic system, acute and chronic infectious diseases, malignant tumors, mental disorders; (9) overlapping with other autoimmune diseases besides Sjogren's syndrome such as systemic lupus erythematosus; (10) The presence of active fibromyalgia was considered by the investigators to make accurate assessment of RA activity in the study difficult; (11) methotrexate tablets intolerance; (12) any of the following specific abnormal laboratory screening values: AST or ALT>1.2 times ULN; Hemoglobin 1.6 upper limit of normal; (13) abnormal 12-lead electrocardiogram (ECG) at screening that is considered by the investigator or sponsor to be clinically significant and may pose an unacceptable risk to study participation; (14) those who are participating in other trials or have participated in other drug clinical trials within 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28(CRP); | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20/50/70;ESR;CRP;Anti-CCP Antibody;RF;MRI evaluation of the affected joint;Visual analogue scale;Health Assessment Questionnaire;TJC28;SJC28;Morning stiffness time;Rest pain score;PhGADA;PaGADA;X-ray for both hands; | — |
Countries
China
Contacts
Public ContactRunyue Huang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed