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Microscopic Polyangiitis clinical trials

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NCT ID: NCT06350110 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

BAH242
Start date: November 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

NCT ID: NCT06294236 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

Start date: April 29, 2024
Phase: Phase 1
Study type: Interventional

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

NCT ID: NCT05716334 Active, not recruiting - Clinical trials for Microscopic Polyangiitis

Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator

BRAVO
Start date: June 15, 2021
Phase:
Study type: Observational

The goal of this multicentre observational study is to compare the safety and effectiveness of rituximab biosimilars to the originator in Canadian patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), two main forms of ANCA-associated vasculitis (AAV). The main questions it aims to answer are: - Is there a difference in vasculitis control between originator and biosimilar rituximab? - Is there a difference in adverse effects between originator and biosimilar rituximab? - In the Canadian healthcare context, are wait times to receive approval (financial coverage) for rituximab shorter for biosimilars compared to originators? Investigators will perform study assessments (including recording disease activity, damage, and adverse events) at the time of participants' usual clinical care visits, at regular intervals for 2 years after starting rituximab (for induction or maintenance treatment) or switching from an originator to a biosimilar as part of their usual care. Researchers will compare outcomes among participants who have received rituximab originators (from 2018 onwards) or biosimilars as part of their usual care, to see if there are differences in relapses, remission rates, damage, serious infections, serious adverse events, and treatment approval wait times.

NCT ID: NCT05703802 Completed - Sepsis Clinical Trials

Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.

Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. Within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice. However, it is unknown if this applies also in humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data.

NCT ID: NCT05376319 Terminated - Clinical trials for Microscopic Polyangiitis

PR3-AAV Resilient Remission or PRRR

Start date: June 30, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab for the treatment of proteinase 3 Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PR3-AAV).

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: NCT04280601 Completed - Clinical trials for Microscopic Polyangiitis

PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

PRAVDA
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This prospective study will assess if 12 months of vitamin D3 (cholecalciferol) supplementation, in patients with AAV (GPA, MPA, and EGPA) who have deficient or insufficient 25(OH)D3 status at enrollment, correlates with improved disease activity and/or lower frequency of relapse (compared to historical data and a previously conducted cross sectional study (part I) that assessed vitamin D status in a cohort of similar patients).

NCT ID: NCT03920722 Active, not recruiting - Clinical trials for Microscopic Polyangiitis (MPA)

Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

RITUXGOPRO
Start date: October 24, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate.

NCT ID: NCT03919825 Completed - Clinical trials for Microscopic Polyangiitis (MPA)

Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen. The FDA-OOPD is one of the funding sources for this study.

NCT ID: NCT03895801 Completed - Clinical trials for Microscopic Polyangiitis (MPA)

Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.

IXchange
Start date: April 3, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).