The Assessment of Prednisone in Remission Trial (TAPIR) - Full Study Description

Find the TAPIR trial on clinicaltrials.gov

About this trial

We are collecting information about and comparing two treatments (standards of care) for patients with GPA who are remission (reduced symptoms or have had no change in symptoms). We will evaluate how patients with GPA do if they are given 5 mg or 0 mg per day of prednisone.

60 individuals with granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) will be enrolled into this trial through the TAPIR trial website.

What will happen

After participants have completed an online consent form, patients will download the Physicians' Packet that they will give to their physician. Patients will request medical record information from their doctor and send it to the TAPIR researchers.

Each participant will be assigned to either take 5 mg or 0 mg per day of prednisone. The chance of being assigned to either dose is 50/50 (and is random, like flipping a coin).

The patient is eligible for the TAPIR trial if the treating physician:

  • Confirms GPA diagnosis

    and

  • Agrees that either randomized treatment assignment (5 mg or 0 mg per day of prednisone) is appropriate for this participant

Participants will receive messages via email, text and social networking tools from the TAPIR trial team and will be prompted to enter specific information online through a personalized trial website:

    • how they are feeling (to see if symptoms associated with GPA worsen)
    • and

    • how much prednisone they are taking

Participation in text messages and social media networking with the TAPIR trial is completely optional and not required for a patient to participate in the study.

All participants will be followed for 6 months, regardless of whether their prednisone dose increases above their randomized trial dose.

Targeted Enrollment

To be eligible to participate, patients  must:

    • have been diagnosed with granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis)
    • Have required treatment with prednisone of more than 20 mg per day/day within the prior 12 months (initial presentation or relapse)
    • Be in disease remission at time of enrollment
    • Daily prednisone dose at time of enrollment is between 5 and 20 mg/day (Please note that participants may be on other medications for the control of their GPA disease besides prednisone and still participate in the TAPIR trial)
    • Be aged 18 years or greater
    • Have agreement from their treating physician that either randomized assignment (5 or 0 mg per day of prednisone) is appropriate for this participant

Patients are not eligible for this trial if:

    • They have another condition that has moderate likelihood of requiring a course of oral prednisone medication within one year of enrollment (for example, COPD, asthma, adrenal insufficiency)

Learn more about the TAPIR trial team >

What if I am taking more than 20 mg of prednisone per day? Find out what you can do to prepare for the TAPIR trial

Ready to join TAPIR?

  • For patients with diagnosed GPA
  • Participate from anywhere - online!
  • Must currently be in remission
  • Continue to see your own doctor

*other conditions may apply. Learn more

Questions Contact our Study Coordinator