primary Sj?gren’s syndrome
Conditions
Interventions
Ll-2 group:IL-2 treatment
non IL-2 group:conventional treatment
Sponsors
the Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 65 years; 2. Subject fulfills the revised the AECG criteria for the classification of pSS; 3. 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; 4. Subject is able to comply with scheduled visits, treatment plans and laboratory tests and other study procedures; 5. 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;Safety assessment Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4+T subgroups;peripheral blood lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactXiaofeng Li
The Second Hospital of Shanxi Medical University
Outcome results
None listed