A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: hrIL-2 activeDrug: hrIL-2 placebo
- Registration Number
- NCT02465580
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets.
This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.
The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
- Detailed Description
Each SLE patients (n=60) with Scores\>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 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 cycles. The end points were safety and clinical and immunologic response.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.
- Under standard treatment (≥ 2 months) at the time of inclusion
- Background treatment failed to control flares or to permit prednisone tapering
- With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
- Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
- SLE disease activity index(SLEDAI) ≥ 8.
- Negative HIV test.
- Negative for hepatitis B and C virus.
- Negative urine pregnancy test.
- Written informed consent form.
- Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
- Serious infection such as bacteremia, sepsis;
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
- History of administration of rituximab or other biologics;
- Purified protein derivative (tuberculin) >10mm
- Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
- Inability to comply with IL-2 treatment regimen.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hrIL-2 active hrIL-2 active Intervention：Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection hrIL-2 placebo hrIL-2 placebo 1 million U doses of placebo s.c. injection
- Primary Outcome Measures
Name Time Method Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE 24 weeks Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
Number of Participants Who Were SLE Responders (SRI) week 24 SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Rheumatology and Immunology, Peking University People's Hospital
🇨🇳Beijing, Beijing, China