CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Interleukin-2drug
Likely dose
1 million units interleukin-2 subcutaneously every other day for 14 days; repeated for 3-6 cycles with 14-day rest between cyclesAI-extracted
Key inclusion· 8
  • ✓Meet American College of Rheumatology criteria for SLE diagnosis
  • ✓On stable standard treatment for ≥2 months at enrollment
  • ✓Disease activity inadequately controlled despite standard therapy, or preventing prednisone reduction
  • ✓At least one active SLE manifestation (thrombocytopenia, rash, oral ulcers, fever, vasculitis, renal involvement with proteinuria >0.5 g/day, or neuro-psychiatric SLE)
Key exclusion· 8
  • ✕Severe chronic dysfunction of liver, kidney, lung, or heart (including NYHA grade III or higher heart failure or transaminases >3 times upper limit of normal)
  • ✕Serious active infection (bacteremia, sepsis)
  • ✕History of cancer, or cancer cured less than 5 years ago (except in situ cervical carcinoma or basal cell carcinoma)
  • ✕High-dose corticosteroid pulse therapy (>1.5 mg/kg) or IV bolus within the last 2 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02084238
NCT02084238N/ACompleted
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Safety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus Erythematosus

Peking University People's Hospital·interventional·Posted Mar 11, 2014·Updated Apr 3, 2020

In Brief

A clinical study evaluating Interleukin-2 for Systemic Lupus Erythematosus. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina
CollaboratorsMonash University

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 11, 2014
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2014
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago

Interventions

Interleukin-2drug

Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease.