The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-16009451
• Date of registration: 2016-10-16
• Prospective Registration: Yes
• Primary sponsor: the Second Hospital of Shanxi Medical University
• Public title: The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus
• Scientific title: The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus
• Date of first enrolment: 2016-11-01
• Target sample size: IL-2 group:20;IL-2 + Rapamycin group :20;non IL-2 or IL-6 antagonist group :20;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=15448
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Shengxiao Zhang
• Affiliation: The Second Hospital of Shanxi Medical University

• Name: Xiaofeng Li
• Affiliation: The Second Hospital of Shanxi Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female aged 18 and 65 years;
2. SLE patients who meet 1997 ACR criteria;
3. Clinical manifestations with one of the following conditions:Thrombocytopenia, disease-associated rash, non-infectious type of fever, mouth ulcers, urinary protein = 0.5g, new onset of vasculitis such as thrombosis and gangrene, NPSLE;
4. The laboratory has at least on of the following conditions: ANA> 1:160, AnuA antibody, dsDNA antibodies, immune globulin, complement C3 and C4 decreased, leukopenia<3×10^9/l, thrombocytopenia<100×10^9/L; The standard treatment is ineffective or relapse;
5. SLEDAI = 5 score;
6. Subject is negative in pregnancy test and agrees to use effective contraception during the study and for at least 6 months after stopping study treatment;
7. Subject is able to comply with scheduled visits, treatment plans and laboratory tests and other study procedures;
8. Subject or subjects legal representative has signed the informed consent form.
Exclusion criteria: 1. Patients are wholly disabled and have little or no self-care ability, such as being bedridden or confined to a wheelchair;
2. Patients have a diagnosis of any systemic inflammatory disease other than SLE such as RA, which symptoms and signs are expected to affect the evaluation of experimental drugs;
3. Patients have a history of malignancy or are suffering malignant disease within 5 years prior to study entry;
4. Patients have a history of chronic or severe infection within 2 months or a history of oppotunistic infection within 6 months;
5. Patients have active hepatitis or suffer from the infection of hepatitis C virus (HCV);
6. Patients suffer from the infection of human immunodeficiency virus (HIV);
7. Patients have a history of lymphoproliferative disease; Have multiple sclerosis or demyelinating disease of central nervous system; Have experienced or are experiencing congestive heart failure; Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness;
8. Treated by rituximab or other biological agents in post three months;
9. Protein purified derivative (PPD) test is positive, or ( and ) X - ray film showed signs of lung infection or have close contact with patients with tuberculosis (TB);
10. Patients were recruited to other clinical trial(s) involving an investigational medicinal product or are currently receiving or have received biological agents therapy within 4 weeks prior to study entry;
11. Patients are allergic to the drug compounds.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

IL-2 group:IL-2;IL-2 + Rapamycin group :IL-2 and Rapamycin;non IL-2 or IL-6 antagonist group :Glucocorticoids and DMARDs;

Primary Outcome(s)

Efficacy endpoint (SLEDAI);

Secondary Outcome(s)

peripheral blood lymphocyte subsets;CD4+T subgroup;

Source(s) of Monetary Support

Self support