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Last Updated: 03/06/2025
PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS
Summary: To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The ...
A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
Summary: The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases
Summary: The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and im...
Pilot Study to EvaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)
Summary: Polymyalgia rheumatica (PMR) is a rheumatologic condition occurring in patients \> 50 years old, characterized by inflammatory pain of the scapular (shoulder) and pelvic (hip) girdles. PMR is most often isolated but can be associated with giant cell arteritis (GCA), a large vessels vasculitis, in 16 to 21% of case. The main features of GCA are headaches, jaw claudication, visual disturbances, abno...
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis
Summary: This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and/or GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR/GCA to GCs.
A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
Summary: To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.
Efficacy and Safety of Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (ITTG PMR): An Open-label 52-week Randomized Controlled Trial
Summary: This will be efficacy and safety of Induction and Tapering Therapy with Tofacitinib and Glucocorticoid in patients with Polymyalgia Rheumatica (ITTG PMR): An open-label 52-week randomized controlled trial
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Summary: This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.
Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles
Summary: The GCAIO study is an innovative, multimodal research initiative designed to enhance the understanding, diagnosis, and management of giant cell arteritis (GCA) and frequently associated polymyalgia rheumatica (PMR). This longitudinal study aims to dissect the complex immunological landscape and systemic manifestations of these conditions through a combination of diagnostic imaging and detailed imm...
VCRC Genetic Repository One-Time DNA Protocol
Summary: The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researc...
A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)/ Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.
Summary: Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 pat...
Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
Summary: The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.
Last Updated: 03/06/2025