Monoclonal Antibody Treatment for Systemic Lupus Erythematosus
Systemic Lupus ErythematosusThis study will examine the safety and effects of the monoclonal antibody MRA in patients with systemic lupus erythematosus (SLE). Antibodies normally fight invading organisms. In autoimmune diseases, such as lupus, however, antibodies attack the body s own tissues. MRA is an antibody manufactured in the laboratory that blocks the action of interleukin-6 (IL-6), a substance that increases antibody production and is involved in inflammation that may cause organ damage in SLE. Patients 18 years of age and older with moderately active systemic lupus erythematosus may be eligible for this 6-month study. Candidates will be screened with blood and urine tests, chest X-ray, electrocardiogram (EKG), and screening tests for certain cancers. Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the clinic. The MRA is infused over a period of about 1 hour through a catheter (thin plastic tube) inserted into an arm vein. Patients will be observed for 1 to 2 hours after each infusion for drug side effects. For the first and last infusions, patients will return to the clinic for blood tests 24 to 48 hours after the infusion. Additional tests may be done if medically indicated. Three different doses of MRA will be used in three groups of patients. The first group (4 patients) will receive the lowest dose. If this dose is well tolerated, a second group (6 patients) will receive a higher dose. If this dose is also well tolerated, a third group (6 patients) will receive the highest study dose. Patients will be evaluated at various intervals for up to 3 months after the last dose of MRA. The follow-up visits will include a review of the patient s medical history, a physical examination, blood and urine tests, and an EKG.
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in...
Systemic Lupus Erythematosus (SLE)The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusThe purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)
Laser Therapy for Patients With Systemic Lupus Erythematosus
Systemic Lupus ErythematosusMuscle Pain1 moreSystemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. The musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. The most common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been used to evaluate this treatment modality on the chewing function and pain values of SLE patients with myogenic TMD.
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusThe reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic...
Systemic Lupus ErythematosusThe study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis).
Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
Systemic Lupus ErythematosusThis is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818. The study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in healthy participants and participants with systemic lupus erythematosus (SLE).
Clinical and Diagnostic Value of Ribosomal p2 Autoantibodies in Systemic Lupus Erythematosus
Systemic Lupus ErythematosusSystemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by production of autoantibodies directed against nuclear and cytoplasmic antigens. Clinically, this disorder is characterized by periods of remission and relapse (1). The early and accurate diagnosis of SLE is challenging (2). The SLE pathogenesis involves multiple cellular components of the innate and immune systems, presence of autoantibodies and immune complexes, engagement of the complement system and cytokine dysregulation (3). About 180 autoantibodies have been identified in SLE patients, 102 of which are reported to have an organ-specific correlation with SLE disease identified in SLE patients, with SLE disease activity (4). However, with the exception of autoantibodies such as antinuclear antibody (ANA), anti double stranded DNA (dsDNA), anti-smith and antiphospholipid antibodies, currently proposed by the American college of rheumatology (ACR) (5)
A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult...
Systemic Lupus ErythematosusThis study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus...
Systemic Lupus Erythematosus (SLE)The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.