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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT04294667 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

PHOENYCS GO
Start date: August 12, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

NCT ID: NCT04233164 Active, not recruiting - Clinical trials for Systemic Lupus Erythematous (SLE)

Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus

Start date: March 4, 2020
Phase: Early Phase 1
Study type: Interventional

Background: The immune system is the body's defense against bacteria and other harmful invaders. In people with systemic lupus erythematosus (SLE), the immune system becomes overactive and attacks healthy cells by mistake. Many people use glucocorticoids (GCs) to treat their SLE. GCs can calm down an overactive immune system by changing how the body reads genes. But GCs have side effects that can increase over time. Researchers want to learn more about how GCs work. This may help to develop new and better drugs for treating SLE without the side effects GCs have. Objective: To better understand how GCs affect the immune system in people with SLE. Eligibility: People age 18-80 with SLE. Design: Participants will be screened with a physical exam. They will have a health and medical history. They will have blood and urine tests. They will have an electrocardiogram to measure heart activity. For this, sticky pads are put on their chest, arms, and legs. Participants will have a methylprednisolone infusion for about 30 minutes. It will be given through a needle in a vein. Blood will be collected immediately before, 2 hours after, and 4 hours after the start of the infusion. Blood pressure and heart activity will be monitored. Participants will repeat some of the screening tests. Participants will be contacted twice in the week after the infusion visit. They will discuss any health problems they are having.

NCT ID: NCT04179032 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)

Start date: November 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. This bridging PK study is part of an extrapolation strategy to support the use of SC belimumab in pediatric SLE participants, based on the completed adult SLE study with SC belimumab and the pediatric SLE study with intravenous (IV) belimumab. Part A is an open label 12-week treatment phase where participants will be enrolled and allocated to treatment cohorts based on their body weight at baseline. The dose and dosing regimens selected for SC administration in this pediatric population are intended to achieve a similar average exposure as observed with the weekly 200 mg SC dosing regimen in adult SLE patients. Part B is an optional 40-week open-label continuation phase, open to all participants who have completed Part A. Dosing of SC belimumab may continue at the same frequency in Part B or may require a change in frequency according to changes in participant body weight. The total duration of the study will be 68 weeks including a 12-Week open label treatment phase (Part A), an optional 40-week open-label continuation phase (Part B) and 16-week follow-up.

NCT ID: NCT04037293 Active, not recruiting - Atherosclerosis Clinical Trials

Premature Atherosclerosis in Systemic Lupus Erythematosus

PASLE
Start date: May 1, 2013
Phase:
Study type: Observational [Patient Registry]

Patients with SLE have increased rates of atherosclerosis, while the risk factors for atherosclerosis in those patients were not fully revealed. This study is an observational study to investigate the natural process and risk factors for atherosclerosis based on a Chinese SLE cohort. Carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) will be measured for each patient at baseline and 5-year follow-up. Blood tests including cholesterol levels, fasting plasma glucose levels and etc. will also be performed.

NCT ID: NCT04018222 Active, not recruiting - Lupus Erythematosus Clinical Trials

Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic

TOTAL FEEDBACK
Start date: May 31, 2019
Phase:
Study type: Observational

This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus. Over a six-month period, the participant will donate blood samples for researchers to evaluate the types of proteins that are in their blood. During this time the participant will also visit a research physician to undergo a physical exam that will include an evaluation of the disease's level of activity. Questionnaires will be answered too, either via email, phone call, or a research app for android and iPhone devices. During this six-month period, if the participant experiences a lupus flare, they are strongly encouraged to visit the research physician to receive a complimentary medical evaluation.

NCT ID: NCT03938324 Active, not recruiting - Cystic Fibrosis Clinical Trials

Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

PiCASO
Start date: October 29, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

NCT ID: NCT03920267 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

NCT ID: NCT03915652 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Addressing Disparities in Lupus Care Through an Integrated Care Management Program

Rheum-iCMP
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to identify lupus patients receiving care at Brigham and Women's Hospital (BWH) who are at high risk for potentially avoidable acute care utilization, inconsistent ambulatory care use, and adverse outcomes. The investigators will invite high-risk lupus patients to participate in an intensive care management program with a nurse manager, and will determine whether this program improves receipt of high quality sustained outpatient care and reduces avoidable emergency department visits and hospitalizations. The investigators will also study the social determinants that contribute to acute care use and avoidable outcomes among lupus patients using semi-structured interviews and a photovoice method.

NCT ID: NCT03746197 Active, not recruiting - Clinical trials for Lupus Erythematosus, Systemic

Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus

Start date: June 6, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether a short interactive video game device is associated with performance on standard measures of attention and problem solving in patients with systemic lupus erythematosus(SLE). The study is also designed to see if playing the video game for four weeks improves attention and problem solving in patients with SLE.

NCT ID: NCT03735238 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Implementing the Decision-Aid for Lupus (IDEAL Strategy)

IDEAL
Start date: December 15, 2018
Phase:
Study type: Observational

The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).