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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2024-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Sjögren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-dose interleukin-2

One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks.

Group Type ACTIVE_COMPARATOR

low-dose interleukin-2

Intervention Type DRUG

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once twice a week, for 12 weeks.

Rapamycin

Rapamycin 0.5ml once per day for 12 weeks.

Group Type ACTIVE_COMPARATOR

rapamycin

Intervention Type DRUG

Rapamycin 0.5ml was taken orally once per day

Low-dose interleukin-2 and rapamycin

One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.

Group Type EXPERIMENTAL

low-dose interleukin-2

Intervention Type DRUG

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once twice a week, for 12 weeks.

rapamycin

Intervention Type DRUG

Rapamycin 0.5ml was taken orally once per day

Interventions

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low-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.

Intervention Type DRUG

rapamycin

Rapamycin 0.5ml was taken orally once per day

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Interleukin-2 sirolimus

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No