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The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 [NCT05162586]).
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This is an Observational Pre-post Study to Observe if the Off Label Use of Anti-IL1 Therapies, Such as Anakinra or Canakinumab, Can Block ACVR1-induced Flare Activity and Heterotopic Ossification in FOP
This is an observational pre-post study to observe if the off label use of anti-IL1 therapies, such as anakinra or canakinumab, can block ACVR1-induced flare activity and heterotopic ossification in FOP. It will also generate key tools and preliminary data that are needed to design a future Phase II study. This study specifically focuses on patients with severe FOP who are being considered by their medical team for rescue therapy with anti-IL1 therapy. Preliminary data suggests patients experience significant decreases in flare frequency when taking anti-IL1 therapy, but other measures of efficacy remain unassessed, such as changes in heterotopic ossification formation, changes...
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Thoracic-Lumbar Arthrodesis- Implanet Jazz
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
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Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
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Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
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Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.
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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).
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Topical Treatment for TMJ Arthralgia
The goal of this clinical trial is to evaluate the efficacy of topical 2.5% hydrocortisone in TMJ arthralgia. The main questions it aims to answer are: - How does pain reduction compare? - How does improvement in jaw function limitation compare? - How do side effects compare? Participants will - On day 1 be examined and report their pain level and jaw function limitation - On days 1-21, apply their cream four times a day - On day 21, report their pain level, jaw function limitation, compliance with instructions, and side effects. Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects...
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Total Joint Arthroplasty (TJA) Weight Loss Study
This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA). The study population will include patients with hip or knee joint osteoarthritis and BMI (Body Mass Index) > 40 kg/m2 who are evaluated in the joint arthroplasty clinic at Boston Medical Center. The primary objective of the study is to determine if bariatric surgery or medical weight loss is more effective than the usual standard of care in optimizing a morbidly obese patient with osteoarthritis of the hip or...
