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Arteritis clinical trials

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NCT ID: NCT03192878 Recruiting - Takayasu Arteritis Clinical Trials

Infliximab Biosimilar in Takayasu's Arteritis

TAKASIM
Start date: March 1, 2017
Phase: N/A
Study type: Observational

Takayasu arteritis (TA) is a chronic inflammatory disease affecting large and medium caliber arteries, particularly the aortic arch and its main branches. Clinical manifestations are caused by the marked thickening of the wall of the involved vessels, resulting in lumen narrowing and ischemia of the tributary districts. Therapy is based on the use of corticosteroids, immunosuppressants, and biologic drugs including infliximab, a monoclonal antibody blocking tissue necrosis factor (TNF)-alpha. Biosimilar infliximab is commercially available and used in the treatment of various immune-mediated conditions. There are currently no data on the efficacy and safety of biosimilar infliximab in the treatment of TA. The investigators propose this monocentric, observational, prospective, open label study to evaluate the efficacy and safety of biosimilar infliximab in the treatment of 30 patients with TA. Specifically, the study will include: I) TA patients refractory to treatment with corticosteroid and/or immmunosuppressive therapy, not previously treated with infliximab; II) TA patients already receiving treatment with originator infliximab. Biosimilar infliximab will be administered at dosages usually employed in the treatment of TA. Specifically, patients not previously treated with the originator drug will receive biosimilar infliximab intravenously at a dose of 5 mg/Kg at time 0, at week 2, at week 4; thereafter, treatment will be administered every 4-6 weeks at a dose of 5-10 mg/kg based on clinical judgement. In patients previously treated with the originator drug, biosimilar infliximab will be administered at the same dosages. To evaluate the efficacy of therapy, changes in clinical manifestations, laboratory examinations, and imaging findings including angio-magnetic resonance imaging (MRI) of thoracic and abdominal vessels and total body PET/CT scan will be evaluate at time 0 as well as 6 and 12 months following treatment initiation. In order to evaluate the safety of the study treatment, the investigators will stringently evaluate possible side effects of treatment, including infusion reactions, changes in laboratory tests, infection, cancer, autoimmune manifestations, neurological and cardiovascular symptoms. The total duration of follow up for each patient will be 52 weeks from enrolment.

NCT ID: NCT03189602 Completed - Takayasu Arteritis Clinical Trials

Pulmonary Artery Involvement in Takayasu's Arteritis

Start date: January 1, 2014
Phase: N/A
Study type: Observational

The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA), and to explore the early clinical features of PA involvement in TA patients.

NCT ID: NCT03146221 Withdrawn - Restenosis Clinical Trials

Search for Restenosis Markers in Lower Limb Arteritis

FEMIA
Start date: June 20, 2017
Phase: N/A
Study type: Interventional

The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes. The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs . This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs. Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.

NCT ID: NCT03096275 Completed - Takayasu Arteritis Clinical Trials

Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's Arteritis

CommittedTA
Start date: March 16, 2017
Phase: Phase 3
Study type: Interventional

Takayasu's arteritis(TAK) is a rare systemic vasculitis which can cause ischemia or inflammation of the involved organs and increase the overall mortality rate.The traditional treatment of TAK is primarily empirical. The most commonly used drugs for treating active TAK are glucocorticosteroids(GC) and immunosuppressants. However, the genital toxicity of CYC has limited its long term use. In a pilot study carried out by the principal investigator of this study has shown that mycophenolate mofetil(MMF) combined with MTX is effective and with few adverse effects. The purpose of this prospective open-label study is to compare the efficacy and safety of GC+MMF+MTX with GC+CYC followed by GC+AZA for the treatment of active TAK. 150 patients with active TAK will be recruited and randomized in a 2:1 ratio to GC+MMF+MTX group and C+CYC and AZA group. Patients were followed for 52 weeks for efficacy and safety assessment.

NCT ID: NCT03026504 Completed - Clinical trials for Arteritis, Giant Cell

Baricitinib in Relapsing Giant Cell Arteritis

Start date: March 9, 2017
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and effectiveness of baricitinib in the treatment of giant cell arteritis. All participants will be taking prednisone at the start of the study. The prednisone will be reduced according to a standardized tapering schedule while participants continue to take one tablet of baricitinib daily for 52 weeks.

NCT ID: NCT02985424 Not yet recruiting - Clinical trials for Giant Cell Arteritis

Polymyalgia Rheumatica and Giant Cell Arteritis

Start date: May 2017
Phase: N/A
Study type: Observational

The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .

NCT ID: NCT02981979 Recruiting - Takayasu Arteritis Clinical Trials

Takayasu Arteritis Clinical Trial in China

TACTIC
Start date: December 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy and Safety of Leflunomide in Patients With Active Phase of Takayasu's Arteritis

NCT ID: NCT02967068 Recruiting - Clinical trials for Giant Cell Arteritis

VCRC Tissue Repository

Start date: November 2016
Phase:
Study type: Observational

The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.

NCT ID: NCT02964364 Recruiting - TAKAYASU ARTERITIS Clinical Trials

China Takayasu Arteritis Registry (CTA Registry)

Start date: August 2016
Phase: N/A
Study type: Observational [Patient Registry]

Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta and its major branches. The epidemiology and pathophysiology of TA is still unclear in China, although many studies have been done. Our previous study supporting by National Natural Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were associated with TA in Chinese han population. Further investigations with larger samples are needed to fully understand the a pathophysiology of TA. The purpose of this study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective disease monitoring and treatment strategies.

NCT ID: NCT02955147 Terminated - Clinical trials for Giant Cell Arteritis

Ustekinumab for the Treatment of Giant Cell Arteritis

UGCA
Start date: December 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)