NCT05605665CompletedPhase 1/2
Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
Source: ClinicalTrials.gov · Last updated 9 Jul 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 29 Oct 2022
- Start date
- 5 Dec 2022
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Sjögren's disease
- NCT number
- NCT05605665
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 30
- From 5 Dec 2022 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are ineffective in high-dose hormone pulse therapy.
Other illness
- Severe chronic liver, kidney and heart dysfunction.
- Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
- Chronic respiratory failure.
- Patients with active tuberculosis infection or potential tuberculosis infection.
Other
- Patients with tumor and tumor history.
- Those who use rituximab or other biological agents within 3 months.
- There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.