The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach

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Brief Title

The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach

Official Title

The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach

Brief Summary

      This study is a multi-center randomized controlled trial to evaluate the effects of using
      low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will
      be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the
      duration of the study (approximately six months) or until a study endpoint.
    

Detailed Description

      Patients with granulomatosis with polyangiitis (GPA, Wegener's) will be recruited at one of
      the Vasculitis Centers of Excellence. Participants will be randomized 1:1 either to taper
      their prednisone dose down to 5 mg/day according to a standardized schedule and stay at 5
      mg/day of prednisone for the duration of the study or until a study endpoint, or taper their
      prednisone dose down to 0 mg/day using a standard schedule and stay at 0 mg/day for the
      duration of the study or until a study endpoint. All study participants will be followed for
      6 months (from reaching a prednisone dose of 5 mg/day) or until an increase of prednisone
      dose (after randomization) occurs, whichever comes first.

      Participants will have up to four study visits, a screening visit (visit 1), a baseline
      (visit 2), a month 3 visit (visit 3) and a month 6 or flare visit (visit 3) and up to two
      follow-up phone calls from the study coordinator at randomization and at month 1
      (randomization and 1 month phone call may be combined if randomization occurs at month 1).

      This study is a project of the Vasculitis Clinical Research Consortium (VCRC) funded through
      the National Institutes of Health Rare Diseases Clinical Research Network (RDCRN) with the
      purpose of promoting vasculitis research. The VCRC is the major clinical research
      infrastructure in North America for the study of vasculitis, and eight VCRC Centers of
      Excellence will be recruiting for this study.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Physician decision to increase glucocorticoids for disease relapse.

Secondary Outcome

 Time to disease flare.

Condition

Granulomatosis With Polyangiitis

Intervention

5 mg Prednisone

Study Arms / Comparison Groups

 5 mg Prednisone
Description:  Subjects will be randomized to a prednisone dose of 5 mg per day 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

159

Start Date

February 2014

Completion Date

December 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Established diagnosis of granulomatosis with polyangiitis (GPA) 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:

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

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

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

             D. 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.

             E. 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 ≥ 5 mg/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, mycophenolate
             sodium, or rituximab. 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 dose reduction or discontinuation for safety purposes/toxicity) for
        the duration of the study.

        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, , [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01940094

Organization ID

VCRC5526A

Secondary IDs

R01HL115041

Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

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


Verification Date

April 2021