Active clinical trials for "Lupus Erythematosus, Systemic"

The Care-coordination Approach to Learning Lupus Self-Management (CALLS) study was designed to examine whether modeling and reinforcement from a lay patient navigator/care coordinator improves disease self-management, indicators of disease activity, health related quality of life (HRQOL), and 30-day readmission in SLE inpatient admissions. We recruited 30 patients (~15 questionnaires and phone sessions and 15 questionnaires only) with active SLE upon hospital admittance at the Medical University of South Carolina (MUSC). The lay patient navigator/care coordinator was trained to deliver intervention content by twelve weekly telephone sessions carried out across the course of the study. All participants were assessed using validated measures of patient reported outcomes at baseline, mid-intervention (6 weeks post-enrollment), and immediately following the intervention (12 weeks post-enrollment). Outcomes for patients who agreed to phone sessions were compared with the outcomes of patients who opted to participate in questionnaires only. The study lasted 12 months, with recruitment and enrollment over 6 months, 3 months for intervention delivery and 3 months for data analysis.

Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined. A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks. The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship. The secondary objectives of the trial are: To evaluate the effect of atacicept in reducing corticosteroid usage To evaluate the safety and tolerability profile of atacicept in subjects with SLE To confirm the PK and PD profiles of atacicept in SLE subjects To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey [SF-36].

Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the physical, social, psychological health and quality of life of patients. Fatigue and pain are aspects of SLE patients which affect their health related quality of life (HRQOL). The purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male and female patients, 18 years and older, will be recruited for a 15-week study, in which patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo. Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and placebo groups at the screening visit, baseline visit, week number 6, and week number 14. Milnacipran has been shown to be an effective treatment for pain, fatigue and physical function in FMS patients. To date, no clinical trials have demonstrated efficacy for the treatment of fatigue in SLE patients with concomitant WSP or FMS. The investigators hypothesize, based on FMS studies, that the milnacipran treated patients will have less fatigue than those in the placebo group. In addition, compared to control arm, those treated with the study drug will have less pain and improved quality of life.

Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.

The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study will look at whether vocational rehabilitation (VR) will improve the ability of employed people with arthritis to keep their jobs. Job retention VR services target key factors that increase the risk of job loss. They aim to modify jobs to reduce barriers caused by functional limitations and disease symptoms, future career planning, and establish a partnership with a VR counselor for ongoing help. We will conduct the study among patients with rheumatic disorders recruited in eastern Massachusetts. We will give 120 study participants job retention services provided by VR counselors. We will give another 120 participants literature about employment- related resources. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in preventing job loss in people with rheumatic disorders.

This is a randomized study exploring the efficacy, safety and steroid sparing ability of two doses (40 U and 80 U) of Acthar in SLE patients with immune mediated hematologic manifestations requiring steroid use for a minimum of 2 weeks prior to screening.

The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.

Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.