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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT02665364 Terminated - Clinical trials for Systemic Lupus Erythematosus

Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Start date: September 23, 2015
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response. The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

NCT ID: NCT02660944 Completed - Clinical trials for Systemic Lupus Erythematosus

A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

Start date: January 3, 2016
Phase: Phase 2
Study type: Interventional

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.

NCT ID: NCT02656082 Completed - Clinical trials for Lupus Erythematosus, Cutaneous

Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus

TARGET-DLE
Start date: February 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Etanercept which is given through intradermal injection is effective in the treatment of discoid lupus erythematosus (DLE). The investigators also would like to develop new tests to measure skin inflammation by scanning the affected skin using optical coherence tomography (OCT), thermography and laser doppler imaging (LDI) and taking photographs of the rash (to be done before and after treatment). If the findings from these new tests are similar to the ones from taking a sample of skin (biopsy), then the latter (which is an invasive test) can be avoided.

NCT ID: NCT02655640 Completed - Clinical trials for Lupus Erythematosus, Systemic

The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis

Start date: October 2015
Phase: N/A
Study type: Observational

This research project has the overall objective to investigate the direction of the associations between illness perceptions, their influencing factors and health-related outcomes. Moreover, the investigators want to look at the direction of the associations between illness perceptions and health related outcomes such as psychological and physical functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc). The investigators want to know whether the outcome variables anxiety, depression, physical (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients' illness perceptions but also the illness perceptions of the General Practitioners (GP) and rheumatologists will be investigated. The researchers want to know if the doctors' perceptions have an impact on the physical and psychological functioning of the patient or vice versa. Much research in the field of illness perceptions is cross-sectional in nature which means that the direction of the relationships between variables is not known.

NCT ID: NCT02653287 Recruiting - Physical Activity Clinical Trials

Lupus Intervention for Fatigue Trial

LIFT
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

NCT ID: NCT02633163 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

Start date: October 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving placebo infusion plus standard of care.

NCT ID: NCT02631005 Completed - Clinical trials for Systemic Lupus Erythematosus

Walk With Ease Program For Patients With Systemic Lupus Erythematosus

Walk SLE
Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook. The book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. Participants will complete questionnaires assessing their symptoms before and after completing the six-week program.

NCT ID: NCT02625831 Completed - Clinical trials for Lupus Erythematosus, Systemic

Anti-ficolin-3 Autoantibodies in Lupus Nephritis

ficolupus
Start date: November 2012
Phase: N/A
Study type: Observational

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. Antibodies against Ficolin-3 were previously identified in the sera of some SLE patients, but their prevalence and significance have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-3 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE. In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-3, anti-dsDNA and anti-C1q antibodies levels were measured in sera by ELISA. First, a highly significant difference was found in the anti-ficolin-3 levels between SLE patients and healthy subjects. Anti-ficolin-3 antibodies were detected as positive in 58 of 165 (35%) SLE patients. The titer of anti-ficolin-3 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-3 antibodies was associated with anti-C1q and anti-dsDNA antibodies. Regarding associations with clinical manifestations, only the presence of active lupus nephritis was significantly associated with the presence of anti-ficolin-3 antibodies (p=0.0001). This association with renal involvement was higher with anti-ficolin-3 antibodies than with other auto-antibodies. Interestingly, the combination of anti-ficolin-3 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker. These results suggest that anti-ficolin-3 could be useful for the diagnosis of active nephritis in SLE patients.

NCT ID: NCT02618967 Completed - Clinical trials for Systemic Lupus Erythematosus

Single Ascending Dose Study of AMG 570 in Healthy Subjects

Start date: March 28, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.

NCT ID: NCT02609789 Completed - Healthy Clinical Trials

A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

Start date: December 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).