Active rheumatoid arthritis of moderate to severe intensity
Conditions
Interventions
Experimental group:Using CMAB806, administer once every 4 weeks (q4w) via intravenous infusion, with treatment observation extending to week 24. The recommended dose of CMAB806 is 8 mg/kg per administ
Folic acid tablets require a stable dose (5-10 mg/week) during the trial.
Control Group:Use Actemra, q4w, intravenous infusion, for treatment observation up to 24 weeks. The recommended dose of Actemra is 8 mg/kg/dose. During the trial, if patients experience abnormal liver
Folic acid tablets, patients need to take a stable dose (5-10 mg/week) of folic acid therapy during the trial.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will enter this trial: 1. Voluntary signing of the informed consent form; 2. Age 18 to 75 years (inclusive); 3. Diagnosed with rheumatoid arthritis (RA) according to the 1987 American College of Rheumatology (ACR) criteria; 4. Judged as having moderate to severe active RA at screening based on the following criteria: >= 4 swollen joints (based on 66 joints) and >= 6 tender joints (based on 68 joints), and must also meet one of the following: C-reactive protein (CRP) > upper limit of normal, erythrocyte sedimentation rate (ESR) > 28 mm/hr, or DAS28-ESR > 3.2; 5. Have received oral methotrexate (MTX) treatment for at least 12 weeks and have been on a stable dose (7.5 - 25 mg/week) for at least 4 weeks before randomization; patients with a history of MTX administration via other routes (subcutaneous, intramuscular, or intravenous) are eligible for the study, but must have been on a stable oral dose of 7.5 - 25 mg/week for at least 4 weeks before randomization; 6. If the subject is taking prednisone or an equivalent dose of glucocorticoid at screening, they must have been on a stable dose (prednisone dose <= 10 mg/day) for at least 4 weeks before randomization.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions will not be eligible for this trial: 1. Body weight > 100kg or < 40kg. 2. ACR functional classification grade IV or long-term bedridden/long-term wheelchair-bound. 3. The investigator determines that the surgery the subject has undergone or is scheduled to undergo may affect the evaluation of the joint under study. 4. Suffering from rheumatic immune diseases other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to rheumatoid arthritis (e.g., vasculitis, pulmonary fibrosis or Felty syndrome). Patients with secondary Sjögren's syndrome associated with rheumatoid arthritis are allowed to enter the study. 5. Having had or currently having inflammatory joint diseases other than rheumatoid arthritis (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease). 6. Primary or secondary immunodeficiency disease (past or current active). 7. Having had or currently having a tumor. 8. Having severe, poorly controlled concomitant diseases, such as (but not limited to) neurological, cardiovascular, liver, kidney, gastrointestinal, endocrine diseases, and the investigator determines that it may prevent the subject from participating in this study. 9. Having any congenital or acquired neurological diseases, vascular diseases or systemic diseases that may affect the efficacy evaluation of this study, especially joint pain and swelling (e.g., Parkinson's disease, cerebral palsy, diabetic neuropathy). 10. Known to have the following infections: recurrent active bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, granulomatous disease found on chest X-ray, hepatitis B and hepatitis C virus infection, HIV infection and herpes zoster, but excluding onychomycosis), or having a history of chronic infection within 6 months before screening, or having any infection outbreak that requires hospitalization or intravenous antibiotic treatment within 4 weeks before screening or oral antibiotic treatment within 2 weeks before screening, or having a history of tuberculosis; for those with positive tuberculosis screening, the investigator may determine whether to include them after preventive treatment. 11. Subjects who have received live vaccines/attenuated vaccines within 4 weeks before the screening visit or are known to receive live vaccines/attenuated vaccines within the 24-week treatment observation period. 12. Having received tocilizumab treatment in the past (except for those who stopped due to economic reasons and were confirmed to be effective by the investigator). 13. Having a history of allergy to the investigational drug. 14. Use of biological DMARDs within the following periods: anakinra, etanercept: within 28 days before administration; adalimumab, infliximab: within 56 days before administration; golimumab, certolizumab: within 70 days before administration; abatacept: within 84 days before administration; denosumab: within 150 days before administration; rituximab: within 180 days before administration. 15. Use of non-biological DMARDs other than MTX within 28 days before administration (excluding chloroquine and hydroxychloroquine; subjects who have used leflunomide within 56 days before administration or have undergone standard cholestyramine treatment or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who reached ACR20 after 24 weeks of treatment compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved ACR50 and ACR70 at 24 weeks compared with baseline;The proportion of subjects who achieved ACR20, ACR50 and ACR70 at 12 weeks compared with baseline;The proportion of subjects who achieved DAS28 ,<= 3.2 and DAS28 <2.6 at 24 weeks of treatment compared with baseline;Improvement in the duration of morning stiffness at 12 and 24 weeks of treatment;Improvement in joint swelling and joint tenderness count at 12 weeks and 24 weeks of treatment;Improvement in the assessment of pain severity by patients at 12 and 24 weeks of treatment, and overall assessment of disease activity by subjects and investigators;Improvement in the 12-week and 24-week health assessment questionnaire (HAQ) scores;Improvement of physicochemical indicators (CRP, ESR) related to efficacy at 12 weeks and 24 weeks of treatment;Safety indicators: treatment period adverse events (TEAE), serious adverse events and their incidence, including abnormal vital signs, physical examination, laboratory tests, electrocardiogram, etc;Immunogenicity indicators: incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (Nab); | — |
Countries
China
Contacts
Public ContactZhanguo Li and Xu Liu
Peking University People's Hospital
Outcome results
None listed