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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Pennsylvania
Sponsor:
Collaborators:
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01940094
First received: September 6, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Granulomatosis With Polyangiitis
Drug: Prednisone 5 mg/day
Drug: Prednisone 0 mg/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Physician decision to increase glucocorticoids for disease relapse. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease flare. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety outcomes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Rate and type of serious adverse events and infections.

  • Protocol performance at VCRC Centers of Excellence. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by Short Form-36

  • Health-related quality of life surveys [ Time Frame: Measured at baseline, month 3, and end of the study ] [ Designated as safety issue: No ]
    Measured by a Patient Global Assessment.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 mg Prednisone
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
Drug: Prednisone 5 mg/day
Subjects will remain on daily prednisone dose of 5 mg
Other Names:
  • •5 mg/day glucocorticoids
  • •5 mg/day prednisone
  • •5 mg/day steroids
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.
Drug: Prednisone 0 mg/day
Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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 Rituximab is an acceptable maintenance agent if the last dose was given at least one month prior to enrollment and no additional doses are planned) for the duration of the study (through the month 6 visit or early termination). If a patient received rituximab and was then prescribed another maintenance agent, the patient is eligible if there are no plans by the treating physician to change the dose of the maintenance (other than for safety purposes/toxicity) for the duration of the study (through the month 6 visit or early termination).

6.2 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.

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940094

Contacts
Contact: Carol McAlear, MA cmcalear@upenn.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy Beinhorn       beinhorn.cynthia@mayo.edu   
Principal Investigator: Ulrich Specks, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Katie Gartner       gartnek@ccf.org   
Principal Investigator: Carol A Langford, MD, MHS         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brian Rice       Brian.Rice@uphs.upenn.edu   
Principal Investigator: Peter A Merkel, MD, MPH         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Dawn McBride, RN       dlmc@pitt.edu   
Principal Investigator: Larry Moreland, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Julieanne Nielsen       Julieanne.Nielsen@hsc.utah.edu   
Principal Investigator: Curry Koening, MD, MS         
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Sandra Messier       smessier@stjosham.on.ca   
Principal Investigator: Nader Khalidi, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: Sam Jagadeesh       sjagadeesh@mtsinai.on.ca   
Principal Investigator: Simon Carette, MD         
Sponsors and Collaborators
University of Pennsylvania
Rare Diseases Clinical Research Network
Investigators
Principal Investigator: Peter A Merkel, MD, MPH University of Pennsylvania
Principal Investigator: Jeffery P Krischer, PhD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: Peter Merkel, Chief, Division of Rheumatology, Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01940094     History of Changes
Other Study ID Numbers: VCRC5526A, R01HL115041
Study First Received: September 6, 2013
Last Updated: September 5, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Granulomatosis with polyangiitis
Wegener's granulomatosis
WG
GPA
ANCA-Associated Vasculitis
AAV
Vasculitis
Prednisone
Glucocorticoid
Taper

Additional relevant MeSH terms:
Prednisone
Systemic Vasculitis
Wegener Granulomatosis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Cardiovascular Diseases
Immune System Diseases
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Vascular Diseases
Vasculitis
Glucocorticoids
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014