Sjögren's Syndrome
Conditions
Brief summary
The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
Detailed description
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.
Interventions
DRUGlow-dose interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\ 6 IU once twice a week, for 12 weeks.
DRUGrapamycin
Rapamycin 0.5ml was taken orally once per day
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, and aged 18-70 at the time of screening visit. 2. Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria. 3. If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment. 4. Disease activity: ESSDAI≥4 points. 5. The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline. 6. 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
1. Severe chronic liver, kidney and heart dysfunction. 2. Severe drug-resistant bacterial infections, such as bacteremia and septicemia. 3. Patients with tumor and tumor history. 4. Chronic respiratory failure. 5. Patients who are ineffective in high-dose hormone pulse therapy. 6. Those who use rituximab or other biological agents within 3 months. 7. Patients with active tuberculosis infection or potential tuberculosis infection. 8. There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Treg cells in peripheral blood | week 12 | Proportion of Treg cells in peripheral blood will be detected by flowcytometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ESSDAI [potential score 0 - 123] | week 12 | ESSDAI is \[European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index\]. Higher scores mean a worse outcome. |
| Physician's Global Disease Activity VAS, (potential score 0 - 10) | week 12 | Physician's Global Disease Activity (10 cm VAS assessing global disease activity from No evidence of disease activity to Extremely active or severe disease activity; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome. |
| Patient's Global Disease Activity VAS, (potential score 0 - 80) | week 12 | Patient's Global Disease Activity (10 cm VAS assessing global disease activity from No evidence of disease activity to Extremely active or severe disease activity; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome. |
| Rate of Participants with adverse effects associated with experimental drugs | week 12 | Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy. |
Countries
China
Outcome results
None listed