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Vasculitis clinical trials

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NCT ID: NCT03765424 Completed - Clinical trials for Giant Cell Arteritis

Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis

Start date: October 1, 2014
Phase:
Study type: Observational

The aim of this project is to prospectively evaluate the diagnostic accuracy of different imaging tools in specific giant cell arteritis disease subsets before and after treatment initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for optimal treatment of GCA patients. Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore, long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to explore the potential of imaging as monitoring and prognostic tools. In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients as compared to a control group of patients with a previous diagnosis of malignant melanoma was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945 and NCT03409913, respectively)

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: NCT03693586 Completed - Chronic Hepatitis c Clinical Trials

Study to Determine the Hepatitis C Virus Infection Prevalence Among Patients Attended Primarily for Vasculitis

Start date: October 19, 2018
Phase:
Study type: Observational

Chronic hepatitis C infection (CHC) is usually asymptomatic; nevertheless, there are studies that show that up to two thirds of patients may present some type of extrahepatic manifestation. The most frequent extrahepatic manifestation is type II mixed cryoglobulinemia (MCG-II) and clinically the most common presentation is leukocytoclastic vasculitis (LCV) with palpable purpura that affects the lower extremities. It is estimated that up to 80% of MCG-II cases are due to CHC. Also, previous studies have demonstrated that CHC prevalence is higher in patients with autoimmune diseases compared with general population. Therefore, if vasculitis is an extrahepatic manifestation of CHC, then the prevalence of CHC infection in this group of patients could be higher than the prevalence reported in general population. The aim of the study is to know the prevalence of CHC, determined by serological rapid test for hepatitis C screening, then all positive cases will be confirmed by quantitative viral load, in patients who consult primarily to a rheumatology department for "vasculitis" or other potential hepatitis C extrahepatic manifestations (rheumatological conditions).

NCT ID: NCT03595761 Completed - Clinical trials for Bacterial Meningitis

Meningitis With Cerebral Vasculitis in Children

Start date: June 1, 2017
Phase:
Study type: Observational

Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome. The investigators decide to realize a retrospective mono-centric study carried out at Montpellier university hospital which looks back at a 7-year study(2009-2016). The Investigators selected purulent meningitis cases based on the bacteriological data provided by the HDB (hospital data base). The Investigators divides in two groups : Group A if patients present a cerebral vasculitis ( radiologic diagnostic by RMI or tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist specialised in neuropaediatrics by a second reading;Group B purulent meningitis with a cerebral vasculitis imaging. Tuberculous meningitis, meningitis in CSF shunt, and in patients having chemotherapy were excluded. The investigators report clinical and biological finding, inflammatory marker at the onset. The Investigators register also the clinical evolution and sequelae

NCT ID: NCT03410290 Completed - Clinical trials for Giant Cell Arteritis

Journey of Patients With Vasculitis From First Symptom to Diagnosis

Start date: January 11, 2018
Phase:
Study type: Observational [Patient Registry]

This study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. Data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. Other aims include identifying factors associated with the time to diagnosis. These factors will be divided into: a) intrinsic factors, or so-called "patient-related factors", such as the type of vasculitis symptoms, patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their symptoms, and other factors, and b) extrinsic factors, or "professional/health system factors", such as healthcare access, referral patterns, testing patterns, and other factors. Understanding such factors can guide future efforts to shorten delays in diagnosis and thereby improve outcomes. All analyses will be done for the population of patients with vasculitis as a whole and by individual types of vasculitis.

NCT ID: NCT03371095 Completed - Vasculitis Clinical Trials

Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease

ITAC
Start date: May 25, 2018
Phase: Phase 3
Study type: Interventional

Behçet's disease (BD) is a systemic vasculitis of arterial and venous vessels of any size, involving young patients (from 15 to 45 years). BD significantly increases morbidity and mortality. Therapeutic management of BD depends on the clinical presentation and organ involved. Although colchicine, nonsteroidal antiinflammatory agents and topical treatments are often sufficient for mucocutaneous and joint involvement, more aggressive approach with immunosuppressive agents is warranted for severe manifestations. Early recognition and vigorous use of immunosuppressives with high dose steroids have changed the prognosis of patients with severe BD. BD is a severe systemic vasculitis leading to blindness in up to 20% at 4 years and a 5-year mortality rate of 15% in patients with major vessel or neurological involvement. Cyclophosphamide has been used for life-threatening BD for 40 years. However, the outcome of severe complications of BD is poor. The European League Against Rheumatism (EULAR) recommendation for the management of BD advocated cyclophosphamide plus glucocorticoids for life-threatening manifestations (i.e neurological and/or major vessel involvement). TNFa antagonists have been used with success in severe and/or resistant cases. In addition, the incidence of blindness in BD has been dramatically reduced in the recent years with the use of anti-TNF. However, there is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD manifestations. The investigators therefore aimed to assess the best induction therapy in severe and difficult to treat BD patients. The investigators hypothesize that up to 70% of the patients with life-threatening manifestations of BD receiving these compounds [anti-TNFa or cyclophosphamide] will achieve a complete remission of BD at 6 months and with less than 0.1 mg/kg/day of prednisone. ITAC, is the first randomized prospective, head to head study, comparing infliximab, to cyclophosphamide in severe manifestations of BD. There is no firm evidence or randomized controlled trials directly addressing the best induction immunosuppressive therapy in severe BD. Cyclophosphamide failed to demonstrate sustainable remission over 70 % of life threatening BD cases. There is little published information on use of immunosuppressants other than cyclophosphamide for severe BD. TNFa antagonists have been used with success in severe and/or resistant cases. TNFa expression correlates with BD activity and other immunological data provide a strong rationale for targeting BD with biologics. Despite a strong rationale, these compounds are not yet approved in BD, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.

NCT ID: NCT03264391 Completed - Behcet Syndrome Clinical Trials

Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography

Start date: March 1, 2018
Phase:
Study type: Observational

Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt. Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT angiography (OCT-A) is a recently developed method that can be used in the evaluation of retinal circulation. In this study, we will test the utility of OCT-A in diagnosis and follow up of retinal vascular changes in cases diagnosed with Behcet's disease that visit the outpatient uveitis clinic of Assiut University hospital, a major tertiary center in southern Egypt, over a one year duration. Also, correlation of OCT-A changes with visual acuity and hence prognosis will be described.

NCT ID: NCT03166319 Completed - Vasculitis, CNS Clinical Trials

Vessel Wall Imaging for Diagnosis and Monitoring of Central Nervous System (CNS) Vasculitis

Start date: July 24, 2017
Phase: N/A
Study type: Interventional

This is a prospective pilot study to determine the utility of MRI and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis.

NCT ID: NCT03069703 Completed - Clinical trials for Invasive Pneumococcal Infection

Innovative Anti-pneumococcal Vaccine Strategies in Patients With ANCA-associated Vasculitis Receiving Rituximab Therapy

PNEUMOVAS
Start date: February 5, 2018
Phase: Phase 2
Study type: Interventional

The study hypothesis is that a "reinforced" pneumococcal combined vaccine strategy in patients with ANCA-associated vasculitides treated with rituximab will induce a better immune response than the current standard regimen, with an acceptable safety profile. This study therefore aims at evaluating the immunogenicity and safety of two "reinforced" innovative pneumococcal vaccine regimen [one double dose at day0 and one double dose at day7 or a quadruple dose of 13-valent anti-pneumococcal conjugate vaccine (PCV13) followed by one dose of 23-valent unconjugated vaccine (PPV23) at month 5], compared to the standard regimen (one dose of PCV13 followed by one dose of PPV23 at month 5), in patients with ANCA-associated vasculitides receiving rituximab therapy.

NCT ID: NCT02994927 Completed - Clinical trials for ANCA-Associated Vasculitis

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

ADVOCATE
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.