The Assessment of Prednisone in Remission Trial

Informed Consent to Participate in Research

Information to Consider Before Taking Part in this Research Study

IRB Study # Pro00013241

You are being asked to take part in a research study. Please read this information carefully and take your time making your decision. You should only take part in this study if you want to volunteer. You are free to participate in this research or withdraw at any time.

We are asking you to take part in a research study called: The Assessment of Prednisone In Remission Trial (TAPIR).

The person who is in charge of this research study is Dr. Jeffrey P. KrischerThis person is called the Principal Investigator.

Purpose of the study

The purpose of this study is to collect information about two different recommended treatments for granulomatosis with polyangiitis (also called "GPA" or Wegener's).

  • Once good control of GPA/Wegener's has been achieved, some experts recommend continuing 5 mg of prednisone to help maintain remission, while other experts recommend coming off of prednisone completely
  • All experts agree that no one knows which approach is better: staying on 5 mg prednisone may or may not reduce the chance of GPA coming back, and coming off of prednisone may or may not reduce the risk of side effects that are known to occur with higher doses of prednisone.
  • We want to find out 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.

If you take part in this study, you will be asked to:

  • Notify the healthcare provider who is already caring for your GPA that you would like to take part in the study. He or she will need to agree that the prednisone dose with which you will be treated while enrolled on the study—either remaining on 5 mg prednisone or coming off of prednisone—is safe and appropriate for you.
  • Enter some information into online questionnaires about how you are feeling and how much prednisone you are taking.
  • Request that the healthcare provider who takes care of you for GPA send your medical records to the study researchers, just so that they can verify that you meet the official definition of GPA and the other rules for participation in the trial.

Your participation in this study will last about 6 months. We expect that during this time you will need to spend a total of about 5 minutes per day entering information about how you are feeling into online questionnaires.

You may also be asked if you are willing to take part in a brief phone interview regarding your experience with the study. You do not have to participate in the phone interview to take part in the study. You may be contacted in the future regarding further opportunities to participate in research.

Total Number of Participants

About 60 individuals will take part in this study.

Alternatives

You do not have to participate in this research study.

Benefits

We are unsure if you will receive any benefits by taking part in this research study.

Risks or Discomfort

As described above ("Purpose of the study"), there are likely pros and cons to remaining on 5 mg prednisone or taking no prednisone. Because both of these approaches to prednisone dosing are considered to be "standard of care," participation in this study is considered to cause you "minimal risk." That means that the risks associated with this study are the same as what you face every day. The only risk to those who take part in this study is the potential loss of privacy if you choose to share your condition through online social media.

Cost

Your doctors' office may charge you to send your medical records to the research team. There will be no other additional costs to you as a result of being in this study.

Compensation

You will be paid $50 in the form of a gift card to be mailed to you for your participation in this research study. The payment will be sent upon the research team's receipt of your medical records from your doctor. An additional $50 gift card will be mailed to you upon receipt of your medical records after you complete the study.

Additionally, you will be compensated with a $25 gift card for any phone interviews in which you choose to take part.

Authorization to Use and Disclose Protected Health Information

As a part of the study, we are asking for information which will identify you, such as: name, address, date of birth, your medical record number from your doctor's office, email address, and phone number. All information about you will be kept confidential and in a secure database. Information about you will be housed at the University of South Florida in Tampa, Florida. We will not share this information with anyone outside of the study team, and we will only use it when we need to in order to complete the research.

As an example, if you have questions about participating in this study we might give your phone number to a researcher who can answer your questions.
Please note that by agreeing to participate, you are giving your permission to use and/or share your health information as described in this document for any and all study/research related purposes. Your authorization to use your health information will not expire unless you revoke it in writing at the address provided below.

Principal Investigator
For IRB Study # Pro00013241
Data Management and Coordinating Center
3650 Spectrum Blvd., Suite 100
Tampa, FL 33612

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Questions, concerns, or complaints

If you have any questions, concerns or complaints about this study, or experience an adverse event or unanticipated problem, call the USF Data Coordinating Center at (813) 396-9237.

If you have questions about your rights as a participant in this study, general questions, or have complaints, concerns or issues you want to discuss with someone outside the research, call the USF IRB at (813) 974-5638.

Consent to Take Part in Research

It is up to you to decide whether you want to take part in this study. If you want to participate, please click "I agree" below to indicate that you freely give your consent to take part in this study and authorize that your health information as agreed above, be collected/disclosed in this study. You understand that by clicking "I agree" below, you are agreeing to take part in this research. You may click the "Print" button to print a copy of this form to take with you.

Verification of your consent to be screened When you click “agree” below, we will send you an e-mail that contains a link to create your MyTAPIR trial profile. We will ask you some questions about yourself and how you would like to be contacted for the duration of the study.

I have read and agree to the terms of the consent form. I understand that by completing this online form, I am consenting to participate in the Assessment of Prednisone in Remission Trial (TAPIR).

In order to complete the online consent process, please enter your e-mail address below.

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Questions Contact our Study Coordinator