ITMCTR2100005277
Recruiting
Phase 4
A multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine0 sitesTBD
Conditionsrheumatoid arthritis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- rheumatoid arthritis
- Sponsor
- The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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;
Outcomes
Primary Outcomes
Not specified
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