welcome to oneGRAVESvoice
- a positively charged Graves' disease and thyroid eye disease community.- join today!
- log in
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves’ Ophthalmopathy
source: U.S. National Library of Medicine
year: 2021
summary/abstract:The purpose of the current study is to confirm safety/tolerability and key pharmacodynamic (PD) effects that are considered to drive clinical benefit in GO patients.
Primary Outcome Measure:
• Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: 7 Weeks ] AE summaries of the number and percent of participants reporting each event at least once will be generated. Other safety data will be summarized descriptively.
• Percentage change from baseline in total IgG and IgG subclasses (1-4) [ Time Frame: 7 Weeks ]
• Percentage change in levels of anti-TSHR antibodies [ Time Frame: 7 Weeks ]
Secondary Outcome Measure:
• Percent change from baseline in proptosis [ Time Frame: 7 Weeks ]
• Total number of proptosis responders [ Time Frame: 7 Weeks ]
• Pharmacokinetics (PK) Parameters of AUC (0-168 h) after first and last dose [ Time Frame: 7 Weeks ]
• Pharmacokinetics (PK) maximum concentration (Cmax) after first and last dose [ Time Frame: 7 Weeks ]
• Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: 7 Weeks ]
• Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies and characterization of any anti-RVT-1401 antibodies to confirm neutralization potential [ Time Frame: 7 Weeks ]
rareRelated
-
Prem Subramanian, MD, PhDPrem S. Subramanian is the Professor of ...
-
Shannath Louise Merbs, MD, PhD, FACSShannath Louise Merbs is a fellowship-tr...
-
Glucocorticoid Regimens for Prevention of Graves’ Ophthalmopathy Progression Following Radioiodine Treatment: ...Background: Glucocorticoid (GC) therapy...
-
Genetic Associations of the Thyroid Stimulating Hormone Receptor Gene With Graves’ Diseases and Graves’ ...Graves' disease (GD) is a common thyroid...
-
Shira L. Robbins, MD, FAAO, FAAPShira Robbins is Clinical Professor and ...
-
“TED Today” Episode 5https://www.facebook.com/ThyroidEyes/vid...
-
Mortality in Graves’ Orbitopathy is Increased and Influenced By Gender, Age and Pre-Existing Morbidity: A Nati...Introduction: It is unclear whether the...