The Assessment of Prednisone in Remission Trial (TAPIR) - Patient Centric Approach

PROTOCOL SUPPLEMENT:

The Assessment of Prednisone in Remission Trial (TAPIR) - Patient Centric Approach

Protocol Number 5526B Supplement

Addendum #1, page 4, Section: Protocol Synopsis

The local study team will include Jason Springer MD MS (local PI) and Mei Liu PhD. The participating sites will include Kansas University Medical Center and target members of the Greater Plains Collaborative (GPC) including Medical College of Wisconsin and University of Texas Southwestern Medical Center. Other participating centers throughout the GPC may be included at a later time. Modifications will be made to the IRB submission prior to including other GPC sites.

Addendum #2, page 7, Section: Detailed Description, paragraph 1

Under the first paragraph, it states that “Patients with granulomatosis with polyangiitis (GPA) will be recruited via Rare Disease Clinical Research Network (RDCRN) VCRC Contact Registry, social medial, and the study public website”. Patients will also be recruited through the participating centers included in this supplement.

Addendum #3, page 7, Section: Detailed Description, paragraph 2

It states ‘The RDCRN VCRC Contact Registry and the social media sites will direct patients to the study public website’. As part of the involvement in the study the GPC will also direct patients to the public website. This will be done only after physician consent that the patient is appropriate for the study.

Addendum #4, page 7, Section: Detailed Description, paragraph 4

The paragraph states, “Participants will receive … Physician packet that the participant will take to his/her treating physician explaining the research study and participant’s involvement in the study”. The local GPC center will communicate with the treating physician. The process includes first identifying the treating physician by the initial query made by a computable phenotype. The treating physician is contacted through e-mail by the local GPC center explaining the study. Within this communication will be questions to determine the eligibility of the patient for the study. The treating physician will give consent if the patient is appropriate for the study. The patient is contacted only after the treating physician’s consent is obtained. Once the patient consents or 2 weeks after the initial physician consent is given, whichever occurs first, the GPC center will contact the treating physician to notify them if the patient has consented.

Addendum #5, page 8, Section: Detailed Description, paragraph 5

The process for reviewing medical records will be different for the patients enrolling as part of the GPC involvement in the study. Once patients have given consent through the patient portal on the V-PPRN website, the V-PPRN will notify the GPC of their enrollment. Communications between the V-PPRN and the GPC will only identify study subjects through a randomized number. The local GPC center will then obtain medical records locally. These medical records will be de-identified and sent back to the GPC coordinating center, KUMC. The records will be reviewed by Jason Springer MD MS. De-identified features of this data, such as if patients meet criteria for diagnosis, will be shared with the V-PPRN.

Addendum #6, page 12, Section: Recruitment

The recruitment of potential participants will be conducted differently with the GPC involvement in the TAPIR trial. The identified centers within the GPC previously mentioned will search for potentially eligible patients by running a computable phenotype query. Each center will run the computable phenotype independently. Once a list of potential participants is generated the treating physician will be identified and contacted by the local center. The local physician will determine eligibility. If eligible, a letter will then be sent to the patient by the local center inviting them to enroll in the study through the patient portal maintained through the V-PPRN.

Addendum #7, page 12-13, Section: Eligibility Criteria, 4di

Throughout this section it mentions that medical records will be reviewed by the ‘Protocol Oversight Management Team’. As part of the GPC involvement in this study Jason Springer MD MS will review de-identified medical records from all the centers after the patient has enrolled. Dr. Springer will confirm eligibility of the patients through review of the medical records at the onset of the study. In addition, de-identified medical records will be obtained at the end of the study.

Addendum #8, page 14, Section: Randomization Procedures

For the GPC, Jason Springer MD MS will be confirming the diagnosis of all participants in the study. In addition, each center will notify the treating physicians on the enrollment status of their patient(s) either immediately after patient consent is given or two weeks after the treating physician has given consent.

Addendum #9, page 14, Section: Visit Frequency/Visit Schedule

The first paragraph mentions a physician packet that will be printed out and brought to the treating physician. Each GPC center will be contacting treating physicians directly. The participant will not have to print out the physician packet as stated in the protocol.

Addendum #10, page 14, Section: Data Elements for Collection.

The treating physician will not need to send in medical records to the research team. Through the GPC, medical records will be obtained through data query searches.

Addendum #11, page 15, Section: Adverse Events

Reported disease activity and adverse symptoms will be review by Jason Springer MD MS on a periodic basely (monthly). The patient should consult the treating physician for any event requiring medical attention. Furthermore, monthly conference calls with the leaders of the participating GPC centers will be organized by Dr. Springer.