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

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ClinicalTrials.gov Identifier: NCT01933724
Recruitment Status : Recruiting
First Posted : September 2, 2013
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
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 Science (NCATS)
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date  ICMJE August 28, 2013
First Posted Date  ICMJE September 2, 2013
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
Prednisone dose increase for disease relapse [ Time Frame: 6 months ]
Physician decision to increase prednisone dose for GPA disease relapse
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01933724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2013)
  • Rates of disease flare sub types [ Time Frame: 6 months ]
    Rates of GPA disease flare sub types: severe versus non-severe
  • Time to event flare [ Time Frame: 6 months ]
    Time from randomization to GPA disease flare
  • Health related quality of life [ Time Frame: 6 months ]
    Health related quality of life as assessed through the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire
  • Safety Outcomes [ Time Frame: 6 months ]
    Serious adverse events and infections
  • Protocol performance [ Time Frame: 6 months ]
    • Patient characteristics
    • Protocol compliance This study is being conducted in parallel to a study at VCRC clinical centers. Protocol performance will be assessed through comparison of participant retention, data completeness, timeliness of data entry, and data accuracy between the two studies.
Original Secondary Outcome Measures  ICMJE Same as current
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 (TAPIR) - Patient Centric Approach
Official Title  ICMJE 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 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
  • Wegener Granulomatosis
  • Vasculitis
Intervention  ICMJE
  • Drug: 5 mg prednisone
    Subjects will be randomized to take 5 mg per day of prednisone for a 6 month period.
    Other Names:
    • 5 mg glucocorticoids
    • 5 mg/day prednisone
  • Drug: 0 mg prednisone
    Subjects will be randomized to taper their prednisone dose to no prednisone for a 6 month period.
    Other Names:
    • no prednisone
    • no glucocorticoids
Study Arms  ICMJE
  • Experimental: 5 mg prednisone
    Subjects will be randomized to 5 mg per day of prednisone for a 6 month period.
    Intervention: Drug: 5 mg prednisone
  • Experimental: 0 mg prednisone
    Subjects will be randomized to 0 mg per day of prednisone dose for a 6 month period.
    Intervention: Drug: 0 mg prednisone
Publications * Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA; Vasculitis Clinical Research Consortium. Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. J Med Internet Res. 2017 Feb 28;19(2):e50. doi: 10.2196/jmir.6798.

*   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: August 28, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

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: Jeffrey Krischer, PhD 1-888-443-1793 TAPIR@epi.usf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01933724
Other Study ID Numbers  ICMJE VCRC 5526B TAPIR
5526B ( Other Identifier: VCRC )
R01HL115041 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • 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 Science (NCATS)
  • Rare Diseases Clinical Research Network
Investigators  ICMJE
Principal Investigator: Peter A Merkel, MD, MPH University of Pennsylvania
Principal Investigator: Jeffrey P Krischer, PhD University of South Florida
PRS Account University of South Florida
Verification Date October 2018

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