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Arteritis clinical trials

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NCT ID: NCT05623592 Active, not recruiting - Clinical trials for Giant Cell Arteritis

Methotrexate as Remission Maintenance Therapy After Remission-Induction With Tocilizumab and Glucocorticoids in Giant Cell Arteritis

MTXinGCA
Start date: November 23, 2022
Phase: Phase 2
Study type: Interventional

The standard treatment for Giant Cell arteritis (GCA) is Glucocorticoids(GC), even if GC-related adverse events are commonly occuring. Therefore, other practises for reducing relapses and cumulative GC-doses are needed. Currently, the Interleukin-6-inhibitor tocilizumab is used in combination with GC to achieve higher remission rates and lower cumulative GC-doses. The use of tocilizumab also has some disadvantages. One is the increased susceptibility to infections. On top of that, a long-term follow-up of the phase II study by Villiger et al. showed a 55% relapse-rate after discontinuation of intravenous tocilizumab after a median of five months. Studies have also shown that methotrexate(MTX) in combination with GC was able to prevent relapses and reduce cumulative GC doses. The aim of the study is to evaluate whether MTX is superior to placebo to prevent relapses in subjects with GCA after Remission-Induction Therapy with Glucocorticoids and Tocilizumab. Our hypothesis is that Methotrexate can maintain remission, once stable remission has been induced by GC and Tocilizumab and will prevent the occurrence of relapses.

NCT ID: NCT05604482 Completed - Diagnoses Disease Clinical Trials

CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Giant cell arteritis (GCA) is the most common vasculitis in the elderly. Accurate diagnosis is of utmost importance in order to then initiate the necessary immunosuppressive therapy. For large-vessel GCA (LV-GCA) involving the aorta and its branches, FDG-PET/CT is the standard in imaging for diagnosis and is recommended by the guidelines. However, this only indirectly visualizes inflammation through vessel wall uptake of glucose. A new PET tracer, 68Ga-pentixafor, is used to visualize the chemokine receptor CXCR4. This receptor is expressed by cells of the immune system. In the context of inflammatory processes, upregulation of CXCL12, the ligand of CXCR4, occurs in affected tissues. The chemotactic effect of this ligand leads to the immigration of CXCR4-positive inflammatory cells into the inflamed area, which can be visualized by PET using the CXCR4-specific tracer 68Ga-Pentixafor. The value of CXCR4-PET should therefore be tested in the context of LV-GCA. This study tests the benefit of CXCR4 in therapy-naïve patients with suspected LV-GCA. For this purpose, patients will receive a FDG-PET and a CXCR4-PET for direct comparison. This is an imaging-only study. Therapy will not be affected by the study. The study is single-arm and not blinded.

NCT ID: NCT05479448 Recruiting - Clinical trials for Giant Cell Arteritis (GCA)

Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis

Start date: June 3, 2022
Phase:
Study type: Observational

This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and/or GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR/GCA to GCs.

NCT ID: NCT05437965 Recruiting - Clinical trials for Coronary Artery Disease

Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

Start date: June 3, 2020
Phase:
Study type: Observational [Patient Registry]

The design of this study is generally divided into two parts: First, establish an isolated coronary arteritis cohort. Then, through the case-control study, the clinical characteristics of patients with isolated coronary arteritis and patients with coronary artery disease are compared and the preliminary screening criteria for patients are constructed. Then, through mass spectrometry flow cytometry and cytokine detection, the biomarkers related to immune inflammation related to the occurrence of coronary artery disease are discussed to provide clues for further exploring the pathogenesis; Subsequently, a prospective cohort study was conducted to compare the clinical characteristics and biomarkers of patients with or without adverse cardiovascular events by following up patients with coronary inflammation, and to explore the prognostic factors of patients with coronary inflammation.

NCT ID: NCT05435781 Recruiting - Clinical trials for Adrenal Insufficiency

Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

RESCUE
Start date: June 7, 2022
Phase: Phase 4
Study type: Interventional

In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.

NCT ID: NCT05388682 Recruiting - Clinical trials for Percutaneous Transluminal Pulmonary Angioplasty

Treatment of Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement

Start date: January 19, 2014
Phase:
Study type: Observational

1. Evaluate the effect of medical treatment and percutaneous transluminal pulmonary angioplasty on takayasu arteritis with pulmonary artery involvement 2. evaluate the efficacy of FAPI in predicting the activity and treatment efficacy of takayasu arteritis with pulmonary artery involvement

NCT ID: NCT05380453 Recruiting - Clinical trials for Giant Cell Arteritis

Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission

GigAINt
Start date: September 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.

NCT ID: NCT05248906 Recruiting - Clinical trials for Giant Cell Arteritis

Giant Cell Arteritis - Optimization of Diagnostics

GAME
Start date: March 19, 2021
Phase:
Study type: Observational

Giant cell arteritis - Optimization of diagnostics

NCT ID: NCT05246540 Completed - Clinical trials for Giant Cell Arteritis

Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis

Cervico-TEP et
Start date: January 1, 2020
Phase:
Study type: Observational

Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery. The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.

NCT ID: NCT05168475 Active, not recruiting - Clinical trials for Giant Cell Arteritis

Biologics in Refractory Vasculitis

BIOVAS
Start date: July 14, 2021
Phase: Phase 2
Study type: Interventional

Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens; this is known as refractory vasculitis. Patients with refractory vasculitis are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects. Biologics are drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Biologics have been used for several years to treat vasculitis, particularly anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV. However, for many of the rarer types of vasculitis, and especially those vasculitis disease types that are not ANCA-associated, there is little information to support use of biologic therapies as effective treatments. The purpose of this trial is to find out whether biologics are effective and represent value for money for participants with refractory vasculitis. The trial will include patients with Non-ANCA-associated vasculitis (NAAV)