Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome

A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.

Inclusion criteria

• Male or female, and aged 18-70 at the time of screening visit.
• Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
• If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
• Disease activity: ESSDAI≥4 points.
• The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
• The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative.

Exclusion criteria

• Severe chronic liver, kidney and heart dysfunction.
• Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
• Patients with tumor and tumor history.
• Chronic respiratory failure.
• Patients who are ineffective in high-dose hormone pulse therapy.
• Those who use rituximab or other biological agents within 3 months.
• Patients with active tuberculosis infection or potential tuberculosis infection.
• There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.