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ANCA-associated Vasculitis clinical trials

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NCT ID: NCT05315141 Recruiting - Clinical trials for ANCA Associated Vasculitis

Multicenter Cohort Study of AAV in Hunan of China

Start date: March 16, 2022
Phase:
Study type: Observational [Patient Registry]

This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.

NCT ID: NCT05197842 Recruiting - Clinical trials for ANCA-associated Vasculitis

Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

Start date: February 22, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.

NCT ID: NCT04923074 Recruiting - Clinical trials for ANCA Associated Vasculitis

the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis

Start date: July 2021
Phase:
Study type: Observational

1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy; 2. On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI; 3. The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA; (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis

NCT ID: NCT04916704 Recruiting - Clinical trials for ANCA Associated Vasculitis

Subclinical Cytomegalovirus Reactivation in Acute ANCA-associated Vasculitis

REACTIVAS
Start date: April 19, 2022
Phase:
Study type: Observational

This is a prospective observational study to determine the frequency and magnitude of Cytomegalovirus (CMV) reactivation in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) in the acute phase of the disease (within 12 months of diagnosis or relapse and commencement of induction of remission therapy) and its association with clinical outcomes. The investigators will also explore whether CMV reactivation causes an increase in CCR2 expressing monocytes, and whether these monocytes cause persistent kidney damage in AAV. The investigators hypothesise that reactivation of CMV during the initial 12 months following diagnosis or relapse of AAV occurs frequently but is generally asymptomatic. Based on the investigators' preliminary data the investigators further hypothesise that subclinical reactivation of CMV during this period will be associated with adverse clinical outcomes, including the severity of vasculitis, the response to treatment and the damage caused by vasculitis. Finally, they hypothesise that subclinical CMV reactivation leads to amplification of renal damage in AAV through a monocyte CCR2/CCL2 driven pathway. The investigators' research has recently shown that asymptomatic reactivation of CMV is a frequent event in AAV patients, occurring in roughly 25% of AAV patients in remission. However, the frequency of asymptomatic reactivation of CMV during the acute phase of the disease is not known. The investigators have previously shown that CMV infection and surrogate markers of CMV reactivation in patients with AAV are associated with worse outcomes such as reduced kidney function, increased risk of infection and death, increased risk of blood clots and increased stiffness of the blood vessels, which is a risk factor for heart disease and stroke. The investigators also have preliminary findings suggesting that in patients with AAV and CMV reactivation, the more CCR2 expressing monocytes in the blood, the worse the kidney function. If CMV reactivation during the acute phase of the disease is common and linked with worse outcomes, this study may then lead on to future research involving treatment to prevent CMV reactivation aiming to improve patient outcomes. The investigators will be looking to recruit patients under the care of the Queen Elizabeth Hospital with newly diagnosed or recently relapsed AAV in the last 2 weeks who are positive for previous CMV infection.The investigators will follow these patients up with 10 visits over 12 months; where possible these will coincide with participants' usual vasculitis clinic appointments. At each visit the participants will be required to give blood and urine samples and answer questions related to their vasculitis. Kidney biopsy tissue taken at diagnosis will be used to assess mechanisms of injury during CMV reactivation.

NCT ID: NCT04737343 Recruiting - Clinical trials for ANCA Associated Vasculitis

Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis

LEFAZAREM
Start date: June 30, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, open-labelled, randomized, controlled,multi-center clincial trial. The aim of this study is to verify that the remission rate of patients treated with Leflunomide is not inferior to that of patients treated with Azathioprine.

NCT ID: NCT04664465 Recruiting - Clinical trials for Giant Cell Arteritis

PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS

PRODIGIOUS
Start date: March 18, 2021
Phase:
Study type: Observational

To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.

NCT ID: NCT04316494 Recruiting - Clinical trials for Microscopic Polyangiitis

Hydroxychloroquine in ANCA Vasculitis Evaluation

HAVEN
Start date: December 17, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to find out whether hydroxychloroquine, in addition to background treatments, reduces disease activity in patients with Anti-Neutrophilic Cytoplasmic Autoantibodies (ANCA) Vasculitis, a group of autoimmune diseases. Hydroxychloroquine and is an established, effective, safe and inexpensive therapy, widely used in other autoimmune diseases such as lupus and rheumatoid arthritis. The study is open to adults diagnosed with certain types of vasculitis, called Granulomatosis Polyangiitis (GPA), Microscopic Polyangiitis (MPA) or Eosinophilic Granulomatosis with Polyangiitis (EGPA). Participants will be eligible if they are treated with background medication to control their vasculitis disease and have a low level of disease activity as defined by a Birmingham Vasculitis Activity Score (BVAS) of greater than 3. Participants will be randomly placed in 1 of 2 groups. Both groups will be given background medication. One group will receive hydroxychloroquine and the other will receive placebo. Participants will be on treatment for 1 year. 76 ANCA Vasculitis participants will be recruited (38 in each treatment arm) from UK vasculitis specialist centres.

NCT ID: NCT03942887 Recruiting - Clinical trials for ANCA Associated Vasculitis

Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

ENDURRANCE-1
Start date: May 3, 2019
Phase: Phase 3
Study type: Interventional

Most recent insights in the treatment for patients with ANCA-associated vasculitis (AAV) have demonstrated that 'tailored' maintenance treatment with rituximab (RTX) is effective to achieve durable remission of disease. As such, RTX re-treatment can be tailored on the basis of relevant clinical and immunological parameters in AAV patients. Now, the present study intends to evaluate whether combining rituximab with cyclophosphamide is superior to current standard of care with rituximab only to induce a favorable clinical and immunological state in AAV patients and can thereby reduce the number of tailored re-treatments with rituximab.

NCT ID: NCT03698071 Recruiting - Clinical trials for ANCA Associated Vasculitis

Soluble CD95 Ligand Role in the Pathophysiology of Antineutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis

VASC-FAS
Start date: December 14, 2018
Phase: N/A
Study type: Interventional

The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

NCT ID: NCT02463578 Recruiting - Clinical trials for Pneumococcal Infection

Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis

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

Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks later).