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Systemic Lupus clinical trials

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NCT ID: NCT04894253 Recruiting - Systemic Lupus Clinical Trials

Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus

LUPCELLVAX
Start date: June 7, 2021
Phase:
Study type: Observational [Patient Registry]

The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population. The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2. The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.

NCT ID: NCT04256577 Not yet recruiting - Systemic Lupus Clinical Trials

Serum Ceramides Level in Systemic Lupus Erythematosus (SLE) Patients as a Novel Marker for Renal Impairment

Start date: February 2020
Phase:
Study type: Observational

1. Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment 2. Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio 3. Follow up estimation of ceramides level in LN patients after 3 cycles of treatment

NCT ID: NCT04108611 Completed - Systemic Lupus Clinical Trials

Immune Adsorption Role in Treatment of Resistant Lupus

HFR
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Background: lupus is a heterogeneous autoimmune disease with autoantibodies formation. Lupus nephritis carries the worst prognosis. C1q deficiency correlates with activity and renal involvement and may help in its evaluation. Therapies include plasma exchange, immune adsorption and recently under evaluation, hemodiafiltration with on-line endogenous re infusion (HFR), in addition to traditional immunosuppressive therapies. Aim: is to evaluate the role of HFR in improving signs and symptoms of SLE activity and laboratory parameters not responding to traditional immune suppressive therapy

NCT ID: NCT03819777 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH)

VOC-PAH
Start date: March 1, 2018
Phase:
Study type: Observational

Aim: to investigate the role of inflammation and auto-immunity in pulmonary arterial hypertension by using the profile of volatile organic compounds. Hypothesis: first, the investigators hypothesize that at time of diagnosis the VOC profiles will discriminate patients with PAH-CTD and idiopathic PAH (IPAH) from patients with systemic sclerosis or systemic lupus erythematosus (CTD) without PAH, supporting the contention that there is a overlapping inflammatory and auto-immune pathway in PAH. During follow-up, the investigators will measure the VOC profiles of patients in all three groups who will be treated according standard clinical care. The hypothesis is that VOC profiles are affected by therapy.

NCT ID: NCT03762824 Completed - Clinical trials for Rheumatoid Arthritis

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

IPS-BOOSTER
Start date: June 14, 2016
Phase: Phase 4
Study type: Interventional

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination and efficacy in preventing invasive pneumococcal disease. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.

NCT ID: NCT03752983 Not yet recruiting - Systemic Lupus Clinical Trials

Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE

Start date: March 1, 2019
Phase:
Study type: Observational

Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis

NCT ID: NCT03749044 Completed - Pre-Eclampsia Clinical Trials

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Start date: May 28, 2018
Phase: N/A
Study type: Interventional

Preeclampsia is a serious maternal condition affecting up to 5% of pregnancies from the general population and up to 30% of lupus pregnancies. Aspirin (acetylsalicylic acid- ASA) has been shown to reduce the risk of preeclampsia, by half, in women at high risk. Therefore, it is recommended that health professionals initiate aspirin early during pregnancy in women with lupus. Despite this recommendation, there are currently no studies of aspirin in women with lupus for this indication. This is a critical knowledge gap as aspirin could potentially have a large benefit in this high-risk population. The investigator will perform a RCT to evaluate the effect of a specifically designed patient educational tool on preeclampsia knowledge and ASA adherence in pregnant women with SLE. The research efforts will improve reproductive health of SLE women and the outcomes of offsprings.

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: NCT03430388 Completed - Clinical trials for Rheumatoid Arthritis

Yellow Fever Vaccine in Patients With Rheumatic Diseases

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

According to World Health Organization (WHO), since December 2016, Brazil is showing a significant increase in cases of yellow fever in humans. In view of this, vaccination is suitable for residents and travelers to the risk area. However, for immunosuppressed patients there is a formal recommendation not to vaccinate with live virus vaccine. On the other hand, the safety and efficacy of the vaccine has been demonstrated in patients with HIV, and safety and seroconversion have also been demonstrated in patients with rheumatic disease who were inadvertently revaccinated for yellow fever. Faced with the impossibility of leaving the high-risk area for some patients the vaccination could be released to only those who have low level of immunosuppression as suggested by some recommendations of medical societies. The availability of a fractional vaccine in the State of São Paulo, which has proved its efficacy, opens the possibility of exposure to a lower number of copies of the virus in the first exposure of immunosuppressed patients, allowing, if necessary, a safer revaccination, after 28 days to obtain of a more effective immunogenic response. The objectives of the study are to evaluate the immune response of the immunization with fractional yellow fever vaccine (neutralizing antibodies) in patients with systemic autoimmune rheumatic diseases residing in a high-risk area. Secondarily, evaluate the possible association between immunogenicity and vaccination with: demographic data, clinical and laboratory activity of the disease in patients with chronic rheumatic diseases, evaluate the curve of viremia and report adverse events. Patients and healthy controls will be vaccinated for yellow fever in the Immunization Center of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). The patients' screening for exclusion and inclusion criteria will be done at the rheumatology outpatient clinic after medical evaluation. For the controls will be the routine screening of the Immunization Center. The vaccination protocol will be a fractional dose of the yellow fever vaccine on day D0 for both groups. Patients will be evaluated on day D0, D5, D10, D30-4 and D365 and controls only on days D0, D10, D30-45 and D365 for aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelets, urea and creatinine, immunoglobulin M (IgM) by immunofluorescence for Yellow Fever, viremia, autoantibodies.

NCT ID: NCT03218033 Completed - Systemic Lupus Clinical Trials

Use of Social Media to Improve Medication Adherence in Adolescents and Young Adults With Systemic Lupus

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

The goal of this study was to examine the effect of an online educational program with and without a social media experience.The primary goal of this study was to determine whether medication adherence would be improved by having adolescents and young adults with systemic lupus erythematosus participate in an online educational website, with or without a social media experience. The secondary goal was to determine whether secondary outcomes such as quality of life, stress, and self-efficacy improved in this model, and whether these changes were associated with improvements in medication management.