Rheumatoid Arthritis
Conditions
Interventions
Study Group:Yunnan Baiyao Plaster
Placebo Control Group:Yunnan Baiyao Plaster Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old (inclusive), regardless of gender. 2. Meets the diagnostic criteria for active rheumatoid arthritis (RA) in accordance with the 2010 ACR/EULAR Classification Criteria for Rheumatoid Arthritis. 3. Disease Activity Score 28 based on Erythrocyte Sedimentation Rate (DAS28-ESR) > 2.6. 4. Involvement of at least 4 joints among wrists, elbows, shoulders, knees or ankles; the Visual Analogue Scale (VAS) score for pain in the target affected joints >= 40 mm. 5. Prior to enrollment, the patient must have received treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) (Tripterygium glycosides excluded), with the treatment regimen and dosage kept stable for >= 4 weeks; the stable regimen and dosage shall be maintained throughout the trial period. 6. Patients who have no prior history of glucocorticoid treatment, or are receiving oral glucocorticoid treatment with prednisone (or prednisolone) (<= 10 mg/day) or equivalent dosage: the type and dosage of the drug must have been stable for at least 30 days before study entry, and the patient agrees to maintain the stable dosage and unchanged drug type during the trial period. Dose reduction or discontinuation is permitted for patients with intolerable adverse reactions. 7. Voluntarily agrees to participate in this clinical trial and signs the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients with any of the following conditions are excluded: (1) Complicated with wrist, elbow, shoulder, knee or ankle joint pain caused by other disorders, including gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), reactive arthritis, mixed connective tissue disease, scleroderma, myositis and dermatomyositis, fibromyalgia (with active symptoms at present), Sjögren’s syndrome, inflammatory bowel disease, Felty syndrome, herpes zoster, trauma, fracture, dislocation, infection, neuropathy, etc. or other diseases that may interfere with efficacy evaluation as judged by the investigator (e.g., osteoarthritis). (2) Complicated with infection; or with a history of severe infection; or with skin/mucosal ulceration and suppuration; or with hand trauma. 2. Patients with any of the following prior treatments that may interfere with efficacy evaluation are not eligible for the trial: (1) Received treatment with non-steroidal anti-inflammatory drugs (NSAIDs), opioids, etc., within 2 weeks prior to the first dose administration. (2) Received treatment with other traditional Chinese medicine (TCM) decoctions or proprietary Chinese medicines for rheumatoid arthritis (RA) with the effects of promoting blood circulation to remove blood stasis and reducing swelling and relieving pain (e.g., Tripterygium Glycosides Tablets) within 2 weeks prior to the first dose administration. (3) Received treatment with targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) within 2 weeks prior to enrollment, including but not limited to upadacitinib, tofacitinib, baricitinib, etc. (4) Received anakinra within 1 week prior to enrollment; etanercept within 4 weeks prior to enrollment; adalimumab, infliximab, certolizumab pegol, golimumab, abatacept, tocilizumab or ixekizumab within 8 weeks prior to enrollment; ustekinumab within 12 weeks prior to enrollment; secukinumab within 16 weeks prior to enrollment; rituximab within 1 year prior to enrollment. (5) Received intra-articular injection therapy within 4 weeks prior to the first dose administration. (6) Received parenteral, trigger point, tender point, intracapsular or intratendinous injection of local glucocorticoids (excluding inhaled or topical glucocorticoids) within 4 weeks prior to the first dose administration. (7) Received any TCM, physical or surgical treatment for RA (e.g., acupuncture, tuina massage, etc.) within 2 weeks prior to the first dose administration. 3. Patients with any of the following comorbidities are not eligible for the trial: (1) Complicated with peptic ulcer/bleeding; or with a history of recurrent peptic ulcer/bleeding; or with a history of gastrointestinal perforation or bleeding induced by NSAID use; or with a history of asthma, urticaria or allergic reaction induced by aspirin or other NSAIDs. (2) Suffering from glucose-6-phosphate dehydrogenase (G6PD) deficiency (favism). (3) Immunocompromised patients. 4. Screening laboratory results showing: total white blood cell count (WBC) = 2× upper limit of normal (ULN); renal function test result showing serum creatinine (Scr) > upper limit of normal (ULN) 6. Patients with severe diseases or a history of diseases involving important organs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS pain score of the target affected area at rest two weeks after treatment initiation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes from baseline in VAS scores for pain at the target affected joints under resting state at Day 3 and Day 7 after treatment initiation, etc., see the detailed description.;Number of days post-treatment until pain relief in the target affected area (VAS score decreased to below 40 mm) compared with baseline.;Change from baseline in IL?6, IL?10, IL?17 and TNF?a at Week 2 post?treatment.;Amount of rescue medication used during the study period.;Improvement rate from baseline in VAS scores for individual symptoms including joint swelling, joint tenderness, limited joint flexion and extension, and morning stiffness in the target affected joint;DAS28-ESR remission rate at Week 2 post-treatment (clinical remission defined as DAS28-ESR = 2.6).;Change from baseline in Patient-Reported Outcome (PRO) scale scores at Day 3, Day 7 and Week 2 post?treatment.;Improvement rate from baseline in each parameter of the ACR response criteria at Day 3, Day 7 and Week 2 post?treatment.;Proportion of subjects with a 50% reduction in VAS pain score of the target affected area at Day 3, Day 7, and Week 2 post-treatment.;Change from baseline in CRP, ESR and RF at Week 2 post?treatment.;Proportion of subjects achieving ACR20 response at Week 2 post-treatment;Change from baseline in DAS28-ESR score at Week 2 post-treatment.; | — |
Countries
China
Contacts
Public ContactLi Zhanguo
Peking University People's Hospital
Outcome results
None listed