Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritis

• Register: ITMCTR
• Last refreshed on: 20 February 2023
• Main ID: ITMCTR2100005277
• Date of registration: 2021-09-05
• Prospective Registration: No
• Primary sponsor: The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
• Public title: Observation on the efficacy of Tripterygium wilfordii polyglycosides tablets combined with Adamumab in the treatment of rheumatoid arthritis
• Scientific title: A multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis
• Date of first enrolment: 2020-07-18
• Target sample size: 1:30;2:30;
• Recruitment status: Recruiting
• URL: http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=56607d6e-4eee-46fa-be00-ed32519f61dc
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Wukai Ma
• Affiliation: The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

• Name: Xueming Yao
• Affiliation: The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Key inclusion & exclusion 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;
(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.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

rheumatoid arthritis

Intervention(s)

1:Tripterygium wilfordii polyglycoside tablets + Adamu monoclonal antibody;2:Methotrexate tablets + Adamu monoclonal antibody ;

Primary Outcome(s)

Low disease activity rate;Clinical remission rate;

Secondary Outcome(s)

Number 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;

Secondary ID(s)

ChiMCTR2100005277

ChiCTR2100050865

Source(s) of Monetary Support

Biaotai Biological Pharmaceutical Co., LTD

Ethics review

Status: Approved
Approval date: 11/08/2021
Contact:

Zengguang Wu