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Prednisone Tapering for Wegener's Granulomatosis (TAPIR Trial)
TAPIR Trial Summary
This trial is testing whether it's better to taper off or stop using prednisone, a medication used to treat inflammation.
TAPIR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTAPIR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TAPIR Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I have a condition like COPD or asthma that might need prednisone treatment within a year.My condition is currently in remission.I have been diagnosed with GPA and meet at least 2 of the specific criteria.I've been on a stable dose of my immunosuppressive medication for the last month and don't plan to change it.I am on one of the listed medications for maintenance therapy.I needed high-dose steroids for my condition in the last year.I am taking between 5 and 20 mg of prednisone daily.I needed more than 20 mg/day of prednisone for my condition in the last year.I am taking TMP/SMX for infection prevention or as a maintenance treatment.I am 18 years old or older.
- Group 1: 5 mg Prednisone
- Group 2: 0 mg Prednisone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any more places open for people who want to participate in this experiment?
"The trial, which was first advertised on February 1st 2014 and had its most recent update on October 11th 2022, is recruiting patients according to the information available on clinicaltrials.gov."
How many research participants are being enrolled in this clinical trial?
"The most recent update on clinicaltrials.gov shows that this trial is still looking for patients and has been since it was first posted on February 1st, 2014. 159 people are needed in total, with 6 different hospitals participating."
What are some conditions that can be healed with a 5 mg dosage of Prednisone?
"A dosage of 5mg of prednisone is most often used to ameliorate thyroiditis. Additionally, it has been found to be an effective course of treatment for ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."
Is the 5 mg dosage of Prednisone an FDA-sanctioned medication?
"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, so our team rates the 5 mg Prednisone as a 3 on the Power scale."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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