Safety of IFNa Kinoid in Systemic Lupus Erythematosus
Summary
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.
This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Systemic Lupus Erythematosus
Intervention
IFN-K
Location
Cliniques Universitaires St Luc
Brussels
Belgium
59037
Status
Not yet recruiting
Source
Neovacs
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01058343
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lupus Erythematosus, Cutaneous
A form of lupus erythematosus in which the skin may be the only organ involved or in which skin involvement precedes the spread into other body systems. It has been classified into three forms - acute (= LUPUS ERYTHEMATOSUS, SYSTEMIC with skin lesions), subacute, and chronic (= LUPUS ERYTHEMATOSUS, DISCOID).
Lupus Erythematosus, Discoid
A chronic form of cutaneous lupus erythematosus (LUPUS ERYTHEMATOSUS, CUTANEOUS) in which the skin lesions mimic those of the systemic form but in which systemic signs are rare. It is characterized by the presence of discoid skin plaques showing varying degrees of edema, erythema, scaliness, follicular plugging, and skin atrophy. Lesions are surrounded by an elevated erythematous border. The condition typically involves the face and scalp, but widespread dissemination may occur.
Antibodies, Anticardiolipin
Antiphospholipid antibodies found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. The antibodies are detected by solid-phase IMMUNOASSAY employing the purified phospholipid antigen CARDIOLIPIN.
Lupus Coagulation Inhibitor
An antiphospholipid antibody found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. In vitro, the antibody interferes with the conversion of prothrombin to thrombin and prolongs the partial thromboplastin time. In vivo, it exerts a procoagulant effect resulting in thrombosis mainly in the larger veins and arteries. It further causes obstetrical complications, including fetal death and spontaneous abortion, as well as a variety of hematologic and neurologic complications.
Antibodies, Antiphospholipid
Autoantibodies directed against phospholipids. These antibodies are characteristically found in patients with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; related autoimmune diseases, some non-autoimmune diseases, and also in healthy individuals.
Clinical Trials
Study of GL701 in Men With Systemic Lupus Erythematosus
Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug mea...
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus. II. Evaluate objective disease parameters, including serum complement levels...
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
Study Evaluating the SBI-087 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
The purpose of this study is to investigate the relationship between the side effects of cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and the gene...
PubMed Articles
Systemic lupus erythematosus complicated with pulmonary hemorrhage in a 17-year old girl.
Pulmonary hemorrhage is a rare and life-threatening complication of systemic lupus erythematosus. In this report, we described a 17-year-old female with pulmonary hemorrhage as an initial manifestatio...
Cardiac tamponade as an initial manifestation of systemic lupus erythematosus in a child.
Cardiac involvement is a rare initial presentation of systemic lupus erythematosus. An 11-year-old girl was described to have massive haemorrhagic pericardial effusion and cardiac tamponade, which was...
Hydroxychloroquine is used extensively in the treatment of systemic lupus erythematosus, not only for its benefit for cutaneous and musculoskeletal lupus, but also for its role in preventing flares, p...
Many immunedeficiency syndromes are associated with autoimmune disorders. We here report on a girl with a systemic lupus erythematosus-like disease who suffered from both hyperimmunoglobulin M syndrom...
