5526: The Assessment of Prednisone In Remission Trial (TAPIR)

For Diseases:

Granulomatosis with Polyangiitis (Wegener's)

Background

Granulomatosis with polyangiitis (Wegener's, GPA) is a form of vasculitis mainly involving small and medium-sized blood vessels. The disease can affect most parts of the body. It commonly affects the sinuses, nose, throat, lungs, ears, eyes, kidneys, skin, joints, brain and other parts of the nervous system.

Prednisone is a necessary treatment for many patients with GPA but can also be damaging to the body. Researchers want to improve daily life for patients with GPA by having them take less prednisone, but without symptoms of GPA becoming worse, if possible.

About this Study

The TAPIR trial will compare two approaches to treatment: a low dose of prednisone, or no prednisone, for patients with GPA who are in remission.

The TAPIR trial will randomize approximately 60 people with GPA to reduce their prednisone dose to either 5 mg or 0 mg a day. If you start the study when your dose is 5 mg of prednisone daily, you will be randomized to continue prednisone at 5 mg or to reduce to 0 mg.

This study involves three study visits at one of the VCRC clinical centers listed below, where you will be seen by a physician that specializes in treating GPA.

You will be asked to provide medical records and provide information about your GPA to the physician. If you are eligible for this study, you will be told how to reduce your daily dose of prednisone to either 5 mg or 0 mg, and will be asked to keep a daily diary monitoring your prednisone dose. You will be asked to return to the hospital in 3 months and in 6 months. Participation in this study may last up to 6 months after you are randomized to one of the two treatment doses.

For each visit, you will be asked to:

• Have a physical exam
• Fill out a feedback form about your life
• Bring your prednisone dose daily diary to review with the physician

18 months after joining the study, your study physician will review your medical chart to see if the dose of prednisone you were taking changed.

Target Enrollment:

To be eligible to participate, you must:

1. Have a diagnosis of granulomatosis with polyangiitis (GPA, Wegener's)
2. Have GPA currently in remission (absence of disease activity/symptoms)
3. Have needed to take 20 mg or more of prednisone each day at some point in the last 12 months
4. Currently be taking a dose of prednisone between 5 and 10 mg daily
5. Be at least 18 years of age
6. If you are currently taking another medication for GPA, it has had to be stable for one month before starting this study

You are not eligible to participate if:

• You have another condition that may cause an increase in prednisone within one year of starting the study. (An example of this would be chronic obstructive pulmonary disease (COPD) or asthma.)

Study Participation

Why participate in this study?
By participating in this clinical trial you will help researchers better understand whether patients with GPA do better if they stay on a maintenance dose of 5 mg of prednisone or come off of prednisone after GPA is well-controlled.

Where will this study take place and how do I participate in this study?
If you are interested in participating in this study or would like additional information, please contact a study coordinator at the clinical center most convenient for you:

Note: This is not a Rare Diseases Clinical Research Network-funded study.