Low-dose IL-2( Interleukin-2) Treatment in SLE

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02084238
• Date of registration: 08/03/2014
• Prospective Registration: No
• Primary sponsor: Peking University People's Hospital
• Public title: Low-dose IL-2( Interleukin-2) Treatment in SLE
• Scientific title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus Erythematosus
• Date of first enrolment: August 2013
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02084238
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Zhanguo Li, MD and PhD
• Affiliation: Peking University Institute of Rheumatology and Immunology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Meet the American College of Rheumatology criteria for the diagnosis of SLE.

- 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.

- Written informed consent form.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Interleukin-2

Primary Outcome(s)

Number of Participants Who Were SLE Responders (SRI) [Time Frame: week 2,week 4,week 6,week 8,week 10]

Secondary Outcome(s)

Safety Assessment [Time Frame: up to Day 180]

The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients [Time Frame: week 0 and week 10]

Number of Relapses [Time Frame: 24 weeks]

Immunological Responses [Time Frame: week 0 and week 10]

SELENA SLEDAI Score [Time Frame: week 0, week 10]

Secondary ID(s)

2014-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Monash University

Results

• Results available: Yes
• Date Posted: 13/04/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02084238