rheumatoid arthritis
Conditions
Interventions
IL-2 group:lL-2
IL-2 + IL-6 antagonist group:Tocilizumab
non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs
Sponsors
the Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 and 65 years; 2. Subject fulfills the revised the 2009 ACR/EULAR criteria for the classification of RA; 3. Active RA is defined as the presence of at least 3 swollen joints and at least 8 tender joints and morning stiffness lasting longer than 60 minutes; 4. At least one of the following: a serum C reactive protein (CRP) level is at least 1.5 times of upper limit or an erythrocyte sedimentation rate (ESR) is at least 28 mm/hour; 5. Subject must meet the following requirements of laboratory tests: (1) Hb85g/LWBC4*10^9/L; Neutrophil 1.5*10^9/L; Platelet 10*10^9/L; (2) Transaminase 1.5 times the upper limit of normal Creatinine 120mol/L (1.4mg/dl); 6. Subject is negative in pregnancy test and agrees to use effective contraception during the study and for at least 6 months after stopping study treatment; 7. Subject is able to comply with scheduled visits, treatment plans and laboratory tests and other study procedures; 8. Subject or subjects legal representative has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients are wholly disabled and have little or no self-care ability, such as being bedridden or confined to a wheelchair; 2. Patients have a diagnosis of any systemic inflammatory disease other than RA such as SLE, which symptoms and signs are expected to affect the evaluation of experimental drugs; 3. Patients have a history of malignancy or are suffering malignant disease within 5 years prior to study entry; Have a history of chronic or severe infection within 2 months or a history of oppotunistic infection within 6 months; Have active hepatitis or suffer from the infection of hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Have a history of lymphoproliferative disease; Have multiple sclerosis or demyelinating disease of central nervous system; Have experienced or are experiencing congestive heart failure; Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; Protein purified derivative (PPD) test is positive, or/and X - ray film showed signs of lung infection or have close contact with patients with tuberculosis (TB); 4. Patients were recruited to other clinical trial(s) involving an investigational medicinal product or are currently receiving or have received biological agents therapy within 4 weeks prior to study entry; 5. Patients are allergic to the drug compounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoint(DAS28); | — |
Secondary
| Measure | Time frame |
|---|---|
| peripheral blood lymphocyte subsets;CD4+T subgroups; | — |
Countries
China
Contacts
Public ContactXiaofeng Li
the Second Hospital of Shanxi Medical University
Outcome results
None listed