Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meeting the 2010 ACR/EULAR classification criteria for rheumatoid arthritis 2. Having a Disease Activity Score (DAS28) > 3.2, or an Erythrocyte Sedimentation Rate (ESR) > 28 mm/h, or a C-reactive Protein (CRP) level > 7.9 mg/dl during the screening period; and a disease duration of >= 6 months; 3. Having a synovial membrane thickness of Grade I (>= 2 mm) or higher; 4. Patients receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying anti-rheumatic drugs (DMARDs) should maintain a stable medication regimen for at least 4 weeks before randomization, i.e., no new drugs are used and the dosage of existing drugs is not changed.
Exclusion criteria
Exclusion criteria: 1. Having a past medical history of or currently suffering from: inflammatory joint diseases other than rheumatoid arthritis (e.g., gout, reactive arthritis, psoriatic arthritis), or other systemic autoimmune diseases (e.g., systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease, etc.); 2. Complicating with severe extra-articular manifestations (e.g., persistent high fever, severe interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neurological lesions, etc.); 3. Having undergone major surgery (including joint surgery) within 2 months before screening; 4. Having a severe infection or persistent infection currently or within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28; | — |
Secondary
| Measure | Time frame |
|---|---|
| erythrocyte sedimentation Rate, ESR;C reactive protein; | — |
Countries
China
Contacts
School of Sports Medicine and Rehabilitation, Shandong First Medical University