Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus.
- Conditions
- Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies.MedDRA version: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 18.0Level: PTClassification code 10067657Term: Systemic lupus erythematosus disease activity index increasedSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-001599-40-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
1. Patients with diagnosis of SLE made and documented by the investigator according to the revised ACR criteria fulfilling = 4 criteria with at least one autoantibody level abnormal (ANA, anti-dsDNA-abs, anti-Sm-abs, anti-Phospholipid-abs).
2. Active SLE patients with a SELENA-SLEDAI = 6 despite previous treatment with at least two different standard immunosuppressive or immunomodulatory therapies.
3. An EC approved written informed consent form signed and dated by the patient must be obtained prior to the performance of any protocol procedures and prior to the administration of the study medication (according to AMG §40 (1) 3b).
4. Stable dosage of standard immunosuppressive or immunomodulatory treatments for at least 4 weeks prior to the first administration of the study medication.
5. Daily dose of glucocorticosteroids must be = 30mg prednisolone (or equivalent) at the day of baseline visit (Visit 2).
6. Age of patients >18 years and = 75 years.
7. Willingness to perform blood analyses and to discontinue therapies which potentially interfere with the study medication.
8. Female patients of childbearing potential must have a negative serological pregnancy test at the screening visit (Visit 1)
9. Female patients of childbearing potential must use at least two reliable methods of birth control (1 of which is a barrier method) during study participation and up to 3 months after completion of the last (4th) treatment cycle.
10. Male patients must agree to use a contraceptive barrier method (eg, condom) with adjunct spermicide during sexual intercourse from the time of the administration of the study medication until at least 3 month after completion of the last (4th) treatment cycle.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
1. Hypersensibility to Aldesleukin or its excipients.
2. Patients with a reduced general condition of 2 or more according to the ECOG (Eastern Cooperative Oncology Group) Performance Status.
3. Severe impairment of vital organ or life-threatening disease.
4. Thrombocytopenia with platelet count of <100.000/µl.
5. Leukocytopenia with WBC of <3.000/µl or neutropenia with a neutrophil count of <1500/µl.
6. Anemia with hemoglobin of <9.0 g/dl.
7. History of thrombotic microangiopathy (TTP).
8. History of thrombosis or thrombotic event (including venous thrombosis, pulmonary embolism, cortical sinus thrombosis, stroke, or arterial embolism causing digital gangrene or tissue necrosis) within the last 6 month prior to the screening visit.
9. Infection requiring antibiotic therapy or infection requiring hospitalisation within the last 4 weeks prior to the baseline visit (Visit 2).
10. Long-term chronically active infectious disease, HIV infection (positive serum antibodies against HIV1/2), active or chronic hepatitis B infection (positive for HBs-Ag in serum), active or chronic hepatitis C infection (positive for serum antibodies against HCV), active tuberculosis.
11. Pleuritis with pleural effusion of clinical relevance (= grade 2 according to the CTCAE v4.03).
12. Pericarditis with pericardial effusion of clinical relevance (= grade 3 according to the CTCAE v4.03).
13. Chronic or acute renal impairment with an eGFR of < 30 ml/min/1.73 m2 (calculated GFR using the MDRD formula with modification for race) or oliguria.
14. Severe impairment of liver function with elevated plasma levels of bilirubin of = 2 mg/dl or an INR of = 1.7.
15. Patients with diagnosis of type-1 diabetes mellitus or of Crohn´s Disease.
16. Patients with inadequately controlled type-2 diabetes mellitus (HbA1c >9%) or patients with type-2 diabetes mellitus and history of recurrent hyperglycemia or hypoglycemia of clinical relevance (= grade 3 according to the CTCAE v4.03).
17. Patients who received allogeneic solid organ transplants, except patients who underwent an autologous or allogeneic hematopoetic stem-cell transplantation (HSCT) more than two years prior to the screening and who did not develop graft-versus-host disease (GvHD).
18. Patients with diagnosis of malignant neoplasm or treatment for malignant neoplasm within the last 5 years prior to the screening visit (Visit 1), except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix.
19. Patients with severe impairment of pulmonary function: severe restrictive lung disease with FVC of <50% of predicted value or obstructive lung disease with FEV1 of <50% of predicted value or O2-saturation of <90% determined by a pulse oxymeter under room air and in resting position.
20. Severe cardiomyopathy or chronic heart failure with an ejection fraction of <30% or of = grade 3 according to the CTCAE v4.03; instable angina pectoris; coronary heart disease with previous stent implantation within the last 3 month prior to the screening visit (Visit 1) or with three-vessel involvement; cardiac intervention or myocardial infarction within the last 12 month prior to the screening visit (Visit1); history of cardiac arrest.
21. Cardiac arrhythmias of clinical relevance or requiring permanent treatment (= grade 2 according to the CTCAE v4.03); persistent or permanent atrial fibrillation; disturbance of transmission of impulses of clinical relevance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method