N/A
N=40
Low-dose IL-2( Interleukin-2) Treatment in SLE
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT02084238 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants Who Were SLE Responders (SRI) — 12; 27; 33; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interleukin-2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peking University People's Hospital
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were SLE Responders (SRI) |
12; 27; 33; 34; 34 | — |
| SECONDARY Immunological Responses |
10.6; 3.93; 4.09; 17.5; 2.1; 2.63 | <0.01 sig |
| SECONDARY The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients |
0.42; 0.075; 417.9; 0.75; 0.157; 105.1 | — |
| SECONDARY SELENA SLEDAI Score |
11.35; 3.775 | — |
| SECONDARY Number of Relapses |
— | — |
| SECONDARY Safety Assessment |
— | — |
Summary
This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02084238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.