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TEPEZZA for Graves' Ophthalmopathy
Study Summary
This trial is testing a new drug to see if it is safe and effective for people with a certain eye disease.
- Graves' Ophthalmopathy
- Thyroid Eye Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You do not need to have eye surgery right away or have plans for eye surgery or radiation during the study.You have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease. You must not have had any surgery on your intestines in the last 6 months or have planned surgery during the trial. You must also be in clinical remission for at least 3 months and not have changed your treatment for inflammatory bowel disease in the past 3 months.
- Group 1: TEPEZZA
- Group 2: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the enrollment cap for this research endeavor?
"This study is no longer recruiting participants, with its last update being posted on November 4th 2022. For those interested in furthering their research into thyroid associated ophthalmopathies, there are presently 266 trials actively accepting candidates and 102 studies looking for patients to join this specific treatment plan."
Has this pharmaceutical intervention been authenticated by the Food and Drug Administration?
"Our team of experts at Power judged the safety rating for this treatment to be 3, due to it being a Phase 4 trial and thus having received approval."
Has this treatment been previously tested during similar clinical tests?
"This treatment was first tested in 2012 at Sieff Medical Center and has since been used in 18747 completed trials. Currently, 102 active clinical studies are currently recruiting patients with a major concentration of them located near Houston, Texas."
Is enrollment for this research project still available?
"Unfortunately, this research is no longer recruiting; the trial was initially posted on September 2nd 2021 and last updated on November 4th 2022. For those still looking for a medical study to participate in, 266 trials relating to thyroid associated opthalmopathies are currently seeking participants while 102 separate studies related to that treatment are actively enrolling patients."
What is the typical application of this treatment regimen?
"This medication is commonly administered to relieve diarrhea, as well as treating conditions like sinus inflammation, general surgery and corneal edema."
Are there several areas within this state where the study is being conducted?
"There are 15 medical sites that offer this trial, including the Neuro-Eye Clinical Trials in Houston, Las Vegas Endocrinology in Las Vegas and the West virginia University Eye Institute in Morgantown. Other locations exist as well."
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