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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT03618056 Completed - HIV Infections Clinical Trials

Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

Start date: December 19, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.

NCT ID: NCT03616964 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)

BRAVE II
Start date: August 2, 2018
Phase: Phase 3
Study type: Interventional

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

NCT ID: NCT03575156 Completed - Clinical trials for Systemic Lupus Erythematosus

Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

MICROLUPS
Start date: September 20, 2018
Phase: N/A
Study type: Interventional

Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

NCT ID: NCT03556007 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)

Start date: April 18, 2018
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in participants with SLE. The study will last about 79 days for each participant.

NCT ID: NCT03541564 Completed - Clinical trials for Systemic Lupus Erythematosus

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

Start date: May 30, 2018
Phase: Phase 1
Study type: Interventional

This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.

NCT ID: NCT03540823 Completed - Sjogren's Syndrome Clinical Trials

Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

Start date: April 23, 2018
Phase: Phase 4
Study type: Interventional

Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus vaccine (20-40%) when compared to A (H1N1) and influenza B. This reduction in efficacy may partly result of the need to propagate A (H3N2) virus into egg components for the preparation of the vaccine. Other factors that may also contribute to the reduction of efficacy against A (H3N2) viruses include the high level of genetic diversity and the rate of rapid evolution of this particular virus subtype and the modification of the immune response to the vaccine secondary of prior infection or vaccination. Vaccine efficacy studies are required to verify the immunogenicity of the H3N2 influenza vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant to evaluate the safety of the vaccine in this population as well as the possibility of reactivation of the rheumatologic disease itself. The objectives of this study are to evaluate the immunogenicity of the H3N2 component of the inactivated and fragmented influenza vaccine in patients with two systemic autoimmune rheumatic diseases (Systemic Lupus Erythematosus - Adult and Juvenile, Primary Sjögren's Syndrome).

NCT ID: NCT03537638 Completed - Clinical trials for Systemic Lupus Erythematosus

Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With SLE

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

Principal objective: To produce scientific knowledge on the effectiveness and cost-effectiveness of a multicomponent intervention for knowledge transfer and implementing a Clinical Practice Guideline (CPG) for Systemic Lupus Erythematosus (SLE), formed by an educative intervention, an computerized clinical decision support system (SADC), complemented by an automated feedback built into the electronic clinical record. Secondary objectives will be previously developed: 1) the analysis of medical practice variations along the care of SLE patients in the Canary Islands Health Service (SCS); 2) the best available scientific evidence to support the optimal development of the SADC; 3) the context and the barriers to innovation implementation in the SCS; and 4) the development of the contents for the implementation strategy, including the SADC and the automated feedback. Methods for the main objective: The main objective will be assessed under an open, multicentric and randomized (by clusters) clinical trial, in the SCS. The multicomponent intervention will be compared to the usual procedures for CPG dissemination. The main measure will be the self-perceived activity of SLE rated by the SLAQ scale. Self-perceived health related quality of life (HRQoL) data will be obtained by means of the questionnaire EQ-5D-5L , to estimate a cost-effectiveness ratio. Methods for secondary objectives: The rest of the objectives will be developed by a mix of quantitative and qualitative research methods to allow adapting the design, development and execution of the intervention to the characteristics of the context.

NCT ID: NCT03504540 Completed - Clinical trials for Age Related Macular Degeneration

Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PL-AMD)

PL-AMD
Start date: April 5, 2018
Phase:
Study type: Observational

The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients. Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration). The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without "pseudo-drusen-like" deposits.

NCT ID: NCT03480529 Completed - Clinical trials for Rheumatoid Arthritis

Monitoring the IMmUological TOXicity of Drugs

MIMUTOX
Start date: March 1, 2018
Phase:
Study type: Observational [Patient Registry]

Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

NCT ID: NCT03451422 Completed - Clinical trials for Systemic Lupus Erythematosus

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus

Start date: April 10, 2018
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).