Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years old, male or female; 2. meet ACR / EULAR 2010 RA classification criteria and scoring system; 3. the disease is active: (1) DAS28 score> 2.6; (2) conventional treatment for more than 3 months do not ease; 4. screening of the subjects must meet the following laboratory inspection requirements: (1) Hb85g / L; WBC 4*10^9/L; neutrophil count 1.5*10^9/L; platelet 100*10^9/L; (2) transaminase normal upper limit of 1.5 times; creatinine 120mol/L (1.4 mg/dl); 5. Th17 is higher than the normal range; or Treg is below the normal range; or Th17/Treg is elevated; 6. Pregnancy tests for women of childbearing age were negative and agreed to take effective contraceptive measures during the trial period and within 6 months after the end of the trial; 7. subjects can be regularly referral.
Exclusion criteria
Exclusion criteria: (1) disabled, bed rest, wheelchair dependent, life can not take care of themselves; (2) suffering from systemic inflammatory disease, the symptoms and signs are expected to affect the evaluation of the test drug, such as: SLE and other rheumatic diseases; (3) screening within 5 years before or now suffering from malignant tumors; a history of chronic infection, nearly 2 months of a serious history of infection or nearly 6 months had chance of infection; currently suffering from active hepatitis or C History of hepatitis; HIV infection; such as lymphoma and other lymphoproliferative diseases; have multiple sclerosis or other central nervous demyelinating disease; have or now suffering from congestive heart failure; have serious, progressive Skin, lung, kidney, kidney, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerve and brain; pure protein derivative (PPD) skin test positive or (and) X-ray showed lung There are signs of infection or close contact with tuberculosis patients; (4) 4 weeks participated in other drug observers or recently used other biological agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood Th17, Treg cells absolute count and the proportion,DAS28 score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Swollen joints, number of pain joints, ESR, CRP, IgS, joint color Doppler ultrasound, HAQ score; | — |
Countries
China
Contacts
Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital