The Assessment of Prednisone In Remission Trial (TAPIR) – Patient Centric Approach

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Brief Title

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

Official Title

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

Brief Summary

      This is a randomized controlled trial in patients with a diagnosis of granulomatosis with
      polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose
      glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment
      entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares.

      This study is a novel approach to conducting a randomized clinical trial in the community
      setting. This study is being conducted in parallel with a similar study at established
      vasculitis institutions. This study will have a patient centric approach to research in that
      subjects will be recruited online and through social media and vasculitis support networks.
      Participants will be consented online and will receive care through their regular treating
      physician so no travel or additional doctor visits are required. Study participants will
      consent to the study and complete online questionnaires about their prednisone dose and about
      how they are feeling.
    

Detailed Description

      This open label pilot study will randomize 60 participants with GPA in remission affecting
      the sinonasal tract, oral mucosa, skin, musculoskeletal system, pulmonary parenchyma, or
      other disease features that warranted an administration of 20 mg/day or more within the last
      12 months. At the time of enrollment, participants will need to be taking prednisone at a
      dose of ≥ 5mg/day and ≤ 20 mg/day. All enrolled participants will be instructed to reduce the
      daily dose of prednisone according to their treating physician. Once participants reach a
      prednisone dose of 5mg/day, they will be randomized at a 1:1 ratio to continue prednisone at
      5 mg/day or to taper prednisone to 0 mg/day. Participants will be followed for approximately
      six months from reaching a prednisone dose of 5 mg/day.

      The primary study outcome is the proportion of participants who increase prednisone for
      disease relapse within 6 months of randomization. Participant data collected via this study
      will be combined with that from a complementary study conducted at Vasculitis Clinical
      Research Consortium (VCRC) clinical centers.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Prednisone dose increase for disease relapse

Secondary Outcome

 Rates of disease flare sub types

Condition

Granulomatosis With Polyangiitis

Intervention

5 mg prednisone

Study Arms / Comparison Groups

 5 mg prednisone
Description:  Subjects will be randomized to 5 mg per day of prednisone for a 6 month period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

February 17, 2014

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Established diagnosis of granulomatosis with polyangiitis (GPA) (verified by medical
             record review by the Protocol Oversight Management Team) where patients will need to
             meet at least 2 of the 5 for the classification of GPA, at least one of which must be
             criterion d or e.

             The modified American College of Rheumatology (ACR) criteria are:

               1. Nasal or oral inflammation, defined as the development of painful or painless
                  oral ulcers or purulent or bloody nasal discharge

               2. Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates,
                  or cavities.

               3. Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per
                  high power field) or red blood cell casts

               4. Granulomatosis inflammation on biopsy, defined as histologic changes showing
                  granulomatous inflammation within the wall of an artery or in the perivascular or
                  extravascular area. Note: Pauci-immune glomerulonephritis seen on kidney biopsy
                  will suffice for this criterion.

               5. Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for
                  proteinase-3 measures by enzyme-linked immunoassay Patients who are
                  myeloperoxidase (MPO) positive or ANCA negative are still eligible for this study
                  if they meet the criteria above and are felt to have GPA.

          2. Active disease within the prior 12 months (initial presentation or relapse) that at
             time of active disease required treatment with prednisone ≥ 20 mg/day

          3. Disease remission at time of enrollment

          4. Prednisone dose at time of enrollment of ≥ 5mg/day and ≤ 20 mg/day

          5. Participant age of 18 years or greater

          6. If the patient is taking an immunosuppressive medication agent other than prednisone
             (maintenance agent) then the maintenance agent must be at a stable dose for one month
             prior to enrollment with no plans by the treating physician to change the dose (other
             than for safety purposes/toxicity) for the duration of the study (through the month 6
             visit or early termination). Acceptable maintenance agents include azathioprine,
             leflunomide, 6-mercaptopurine, methotrexate, mycophenolate mofetil, rituximab, or
             mycophenolate sodium. Patients may be on trimethoprim/sulfamethoxazole (TMP/SMX) for
             use as either a maintenance agent or for prophylaxis for infection. TMP/SMX may be
             used in combination with other drugs.

             6.1 If the patient is regularly taking trimethoprim/sulfamethoxazole at any dose then
             the patient is eligible if there no plans by the treating physician to change the dose
             after enrollment (other than for dose reduction or discontinuation for safety
             purposes/toxicity) for the duration of the study.

          7. Agreement from Treating Physician that 0mg/day of prednisone or 5mg/day of prednisone
             is standard of care

          8. Participant's Treating Physician is located in the United States

        Exclusion Criteria:

        1. Comorbid condition that has moderate likelihood of requiring a course of prednisone
        within one year of enrollment (e.g. chronic obstructive pulmonary disease (COPD), asthma,
        adrenal insufficiency).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter A Merkel, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01933724

Organization ID

VCRC 5526B TAPIR

Secondary IDs

5526B

Responsible Party

Sponsor

Study Sponsor

University of South Florida

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Peter A Merkel, MD, MPH, Principal Investigator, University of Pennsylvania


Verification Date

December 2020