Active clinical trials for "Lupus Erythematosus, Systemic"

This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids will be encouraged during the first 20 weeks of both the randomized and open label extension portions of the trial. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48.If indicated by the PI, brief increases in corticosteroids are permitted during the first 20 weeks of both the blinded and open label extension portion of the trial. The increase in prednisone (or equivalent) dose is limited to 2X the back-ground level to a maximum of20 mg/day for a maximum of 1 week (7 days) or to a single administration of intravenous methylprednisolone or equivalent at a maximum dose of 500mg. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48

SLE is mostly seen in young women and causes significant deformity in patients. In SLE, disease activity, body damage due to disease or treatment, comorbidities, and drugs affect body image negatively. SLE causes changes in the body such as skin rashes, uneven pigmentation, vitiligo, scars, tooth loss, alopecia, increased facial hair, stretch marks, weight gain, fatigue, pain, depression, the unpredictability of exacerbations or lack of independence, which worsens the subjective well-being of patients. can affect in that direction. Subjective well-being (SBL) is the scientific term for happiness, and SLE is thought to have a significant negative impact on SWB.

Background: Systemic lupus erythematosus (lupus) is an autoimmune disease that often involves many systems and organs of the body. Symptoms can include fever, joint pains, and rashes. Serious lupus can also damage organs like the kidneys, lungs, or brain. Drugs used for lupus can have serious side effects. Also, the drugs don t help some people. Researchers want to find new, more effective and safe treatments. Objective: To evaluate the safety and tolerability of the drug tofacitinib (study drug) in people with lupus. Eligibility: People ages 18 and older who have mild to moderate lupus and are not currently or haven t recently had certain lupus treatments. Design: Participants will be screened in another protocol. Participants will have 7 five-hour visits over about 3 months. They will fill out multiple questionnaires. They will have tests, including: Physical exam Blood and urine tests ECG/EKG: Soft electrodes are stuck to the skin to monitor the heart. Optional SphygmoCor: Cuffs are attached to the arm and thigh to measure blood pressure and flow speed. Optional Endopat: A thimble-shaped cup is placed on the finger to measure blood flow. A cuff is put on the arm to measure blood pressure and flow. Optional CAVI: ECG electrodes are placed on both wrists, a microphone placed on the chest, and a blood pressure cuff placed on each arm and leg to measure blood pressure and velocity. Participants will receive either the study drug or a placebo. They will take this twice a day by mouth for 56 days. Participants will be contacted by phone 4 times....

The goal of the proposed project is to enhance the Principal Investigator's research ability to conduct behavioral interventions for people with lupus. This includes intervention design, implementation, data collection and data analysis. The Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a uniquely tailored intervention program can improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African American lupus patients. This study builds on three decades of work conducted in the field of arthritis self-management but differs in that the intervention mode, the disease (lupus), and the study population (African-Americans) are unstudied or understudied. The IQAN Project will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its theoretical framework. This program has three specific aims. The first aim seeks to design a three armed randomized, wait list controlled trial that employs a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them to choose as many or few as they wish. The second aim is to assess the intervention, using the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use previously collected data to characterize patient-centric barriers to care in African-American lupus patients, in order to identify trends in patient needs and desires, as well as correlates of non-response and non-compliance that can be used in the development and refinement of the intervention.

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets. This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).

This is a multi-center, double-blinded, randomized, placebo-controlled, phase 2 study to evaluate the efficacy and safety of sirolimus administered in addition to standard therapy, in patients with active SLE disease.