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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940094
Recruitment Status : Recruiting
First Posted : September 11, 2013
Last Update Posted : October 12, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Sciences (NCATS)
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date October 12, 2022
Actual Study Start Date  ICMJE February 2014
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
Physician decision to increase glucocorticoids for disease relapse. [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Time to disease flare. [ Time Frame: 6 months ]
  • Safety outcomes. [ Time Frame: 6 months ]
    Rate and type of serious adverse events and infections.
  • Protocol performance at VCRC Centers of Excellence. [ Time Frame: 6 months ]
    Evaluation of patient characteristics, protocol compliance, participant retention, data completeness, timeliness of data entry, and data accuracy.
  • Health-related quality of life survey [ Time Frame: Measured at baseline and end of the study ]
    Patient Reported Outcomes Measurement Information System (PROMIS) Assessment
  • Health-related quality of life surveys [ Time Frame: Measured at baseline and the end of the study ]
    Measured by Short Form-36
  • Health-related quality of life surveys [ Time Frame: Measured at baseline, month 3, and end of the study ]
    Measured by a Patient Global Assessment.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
  • Time to disease flare. [ Time Frame: 6 months ]
  • Health-related quality of life surveys. [ Time Frame: 6 months ]
    Measured by Short Form-36, PROMIS Assessment, and Patient Global Assessment.
  • Safety outcomes. [ Time Frame: 6 months ]
    Rate and type of serious adverse events and infections.
  • Protocol performance at VCRC Centers of Excellence. [ Time Frame: 6 months ]
    Evaluation of patient characteristics, protocol compliance, participant retention, data completeness, timeliness of data entry, and data accuracy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Granulomatosis With Polyangiitis
Intervention  ICMJE
  • Drug: 5 mg Prednisone
    Subjects will remain on daily prednisone dose of 5 mg
    Other Names:
    • •5 mg/day glucocorticoids
    • •5 mg/day prednisone
    • •5 mg/day steroids
  • Drug: 0 mg Prednisone
    Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day
Study Arms  ICMJE
  • Experimental: 5 mg Prednisone
    Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
    Intervention: Drug: 5 mg Prednisone
  • Experimental: 0 mg Prednisone
    Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
    Intervention: Drug: 0 mg Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
159
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2013)
60
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carol McAlear, MA cmcalear@upenn.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940094
Other Study ID Numbers  ICMJE VCRC5526A
R01HL115041 ( U.S. NIH Grant/Contract )
U54AR057319 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Peter Merkel, University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Office of Rare Diseases (ORD)
  • National Center for Advancing Translational Sciences (NCATS)
  • Rare Diseases Clinical Research Network
Investigators  ICMJE
Principal Investigator: Peter A Merkel, MD, MPH University of Pennsylvania
Principal Investigator: Jeffery P Krischer, PhD University of South Florida
PRS Account University of Pennsylvania
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP