Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN).A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMM

Charité - Universitätsmedizin Berlin0 sites12 target enrollmentNovember 14, 2013

ConditionsPatients 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 disorders MedDRA version: 18.0Level: PTClassification code 10067657Term: Systemic lupus erythematosus disease activity index increasedSystem Organ Class: 10022891 - Investigations Therapeutic area: Diseases [C] - Immune System Diseases [C20]

DrugsProleukin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies.
Sponsor: Charité - Universitätsmedizin Berlin
Enrollment: 12
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 14, 2013

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Charité - Universitätsmedizin Berlin

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.