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An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.
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Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
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A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus
The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess...
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A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
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Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis
The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).
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Cervical Interbody Implant Study
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
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Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement
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Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
The purpose of this clinical study is to evaluate fusion of the SI joint(s) and any reduction in VAS pain scores in a prospective cohort of patients utilizing the SiJoin® Transfixing Sacroiliac Fusion Device in patients that received sacroiliac fusion, without ancillary stabilization devices.
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Comparative Autoantibody and Immunologic Cell Marker Study
The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.
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Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery
Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).
