Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritis
- Conditions
- rheumatoid arthritis
- Registration Number
- ITMCTR2100005277
- Lead Sponsor
- The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Male (50-65 years old) or female (50-65 years old); or patients without fertility requirements;
(2) Meet the RA classification criteria of ACR/EULAR in 2010;
(3) After treatment with two or more traditional DMARDs (one of which is methotrexate) for 6 months or more, DAS28-ESR 3.2;
(4) Subjects are ready to start using Geleli (adamumab);
(5) Obtain informed consent.
(1) For those who are allergic to other ingredients in experimental drugs or preparations;
(2) body mass index [BMI] greater than 30.0 x BMI = weight (kg) / height 2 (m) (square of height);
(3) women who are pregnant or lactating and women who plan to become pregnant are unwilling or do not take adequate contraceptive measures; male patients who are unwilling or do not take adequate contraceptive measures.
(4) patients with old or active tuberculosis during acute or chronic infection, patients with viral hepatitis B;
(5) patients with malignant tumors;
(6) patients with moderate and severe heart failure (Grade 3-4 of the New York Heart Association);
(7) demyelinating diseases of the central nervous system;
(8) those diagnosed with other rheumatic immune system diseases, such as systemic erythematous wolves, ankylosing spondylitis, etc.
(9) active liver disease, or abnormal liver function, AST or ALT 2 times higher than the upper limit of the normal range;
(10) use of biological / targeted DMARDS; in the past three months;
(11) long-term history of glucocorticoid use, daily dose equal to prednisone >= 10mg;
(12) White blood cell count (WBC) < 4.0 x 10^9 / L, platelet count (PLT) < 100 x 10^9 / L, red egg (HGB) < 90g/L.
(13) those who are unable or unwilling to provide informed consent or are unable to comply with the requirements of the trial;
(14) owners who are considered by the researchers to be unsuitable to participate in this study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ow disease activity rate;Clinical remission rate;
- Secondary Outcome Measures
Name Time Method umber of pain joints;Rheumatoid factor;C-reactive protein;Anti-cyclic citrullinated peptide antibody;Erythrocyte sedimentation rate;Pain VAS score;Number of swollen joints;Number of swollen joints;