Clinical Trials

Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for ...

The purpose of this study is to Identify who makes up the AAV caregiver demographic and what their social background is. Understand the perceived loss in the patient’s quality of life from the caregiver’s perspective since diagnosis. Analyze perceived caregiver burden while comparing results of two validated caregiver survey instruments.

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.

The primary purpose of this study is to evaluate the effectiveness and safety of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

The purpose of this study is to evaluate the effectiveness and safety of RoActemra/Actemra (tocilizumab) for the treatment of patients who have giant cell arteritis.

The purpose of this study is to find out if advanced ultrasound studies can be used to make a diagnosis of giant cell arteritis. Ultimately, we hope to be able to offer non-invasive diagnostic options as an alternative to biopsy to future patients who are being evaluated for giant cell arteritis.

The purpose of this study is to determine the effectiveness of abatacept in Giant Cell Arteritis (GCA).  Patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized to receive subcutaneous abatacept or placebo.  All patients will receive glucocorticoids (GC) which will be tapered and discontinued by week 26 according to a standardized schedule. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months, or who are ...

The purpose of this study is to determine the proportion of patients achieving both complete remission and seronegativity for Anti-Neutrophil Cytoplasmic Antibody (ANCA) at 6 months. 

The study is a double-blind, randomized, active controlled phase 2 study.  It will take place at multiple sites and enroll 30 patients who have clinical diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis (PR3-AAV).  It will look at the study drug, Obinutuzumab, for the treatment of these diagnosis and evaulate the safety of the drug.  Subjects will be followed for 18 months after first treatment.  The study will complete when all enrolled subjects are have been ...

The primary objective of the study is to evaluate the effectiveness of depemokimab 200 mg SC every 26 weeks compared with mepolizumab 300 mg SC every 4 weeks in participants with relapsing or refractory EGPA receiving Standard of Care (SoC) therapy with the endpoint of remission (i.e., a Birmingham Vasculitis Activity Score (BVAS)=0 and a dose of oral corticosteroids (OCS) ≤ 4mg/day) at both Week 36 and Week 52.

The aim of this study is to investigate the effectiveness and safety of depemokimab 200 mg (administered as 100 mg x 2) SC injections every 26 weeks compared with mepolizumab 300 mg (administered as 100 mg x 3) SC injections every 4 weeks in ...

The purpose of this study is to evaluate the effectiveness and safety of Benralizumab compared to Mepolizumab to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving standard of care (SOC) therapy.

The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.

Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) ...

This study is being done to create a "resource" of samples that can be used to improve our ability to diagnose and treat MN, IgAN, MPGN, FSGS/MCD, Lupus Nephritis, AAV, other glomerular tubulo-interstitial disease.

The purpose of the study is to learn more about inflammatory diseases of the central nervous system (CNS) by collecting patient information, blood sample (which contain a person’s genes, DNA) and other available tissue samples.

The purpose of this study is to develop a repository of serum and urine samples from patients with AAV to support future studies into the development of such biomarkers. 

The purpose of this study is to assess the safety of mesenchymal stem cells in patients with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorders (CTD).

The purpose of  this study is to determine the usefulness of palliative care consultations by a specialty physician and a pulmonologist for patients who have advanced lung disease.