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Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
Rochester, MN
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would ...
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The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach
Rochester, MN
This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.
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PR3-AAV Resilient Remission or PRRR
Rochester, MN
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 ...
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A Study to Evaluate the Safety and Effectiveness of IFX-1 in Add-on to Standard of Care in Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) compared with placebo.
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Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Rochester, MN
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.
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Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
Rochester, MN
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) ...