Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Low-dose interleukin-2 One million IU of IL-2 was injected subcutaneously once every other day for 4 weeks. |
Drug: low-dose interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 4 weeks.
Other Names:
|
| Active Comparator: Rapamycin Rapamycin 0.5ml once per day for 4 weeks. |
Drug: rapamycin
Rapamycin 0.5ml was taken orally once per day
Other Names:
|
| Experimental: Low-dose interleukin-2 and rapamycin One million IU of IL-2 was injected subcutaneously once every other day and rapamycin 0.5ml once per day for 4 weeks. |
Drug: low-dose interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 4 weeks.
Other Names:
Drug: rapamycin
Rapamycin 0.5ml was taken orally once per day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of Treg cells in peripheral blood [week 4]
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
Secondary Outcome Measures
- ESSDAI [potential score 0 - 123] [week 4]
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 4]
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 4]
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 4]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, and aged 18-70 at the time of screening visit.
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Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
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If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
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Disease activity: ESSDAI≥4 points.
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The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
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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:
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Severe chronic liver, kidney and heart dysfunction.
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Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
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Patients with tumor and tumor history.
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Chronic respiratory failure.
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Patients who are ineffective in high-dose hormone pulse therapy.
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Those who use rituximab or other biological agents within 3 months.
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Patients with active tuberculosis infection or potential tuberculosis infection.
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There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking university people's hospital | Beijing | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- Study Director: Zhanguo Li, Peking university peoples hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Rapa-IL2-SS