Granulomatosis With PolyangiitisPhase 3TAPIRNCT01940094
The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach
A Phase 3 study testing 5 mg Prednisone and 0 mg Prednisone in people with Granulomatosis With Polyangiitis, run by University of Pennsylvania at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis
- What is being tested?
- 5 mg Prednisone and 0 mg Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2014to Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge.
- Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities.
- Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per high power field) or red blood cell casts.
- 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.
Show all 14Show fewer
- 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.
- Active disease within the prior 12 months (initial presentation or relapse) that at time of active disease required treatment with prednisone >20 mg/day.
- Disease remission at time of enrollment.
- Prednisone dose at time of enrollment of ≥ 5 mg/day and ≤ 20 mg/day.
- Participant age of 18 years or greater.
- 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.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
Canada2 sites
St. Joseph's Healthcare
Hamilton, Ontario
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
About this study
Official title: The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach
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.
Read the 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.
- Conditions
- Granulomatosis With Polyangiitis
- Being tested
- 5 mg Prednisone, 0 mg Prednisone
- Keywords
- Granulomatosis with polyangiitis, Wegener's granulomatosis, WG, GPA, ANCA-Associated Vasculitis, AAV, Vasculitis, Prednisone, Glucocorticoid, Taper
- Medical subject headings
- Granulomatosis with Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg PrednisoneDrug
Also called •5 mg/day glucocorticoids, •5 mg/day prednisone, •5 mg/day steroids
Subjects will remain on daily prednisone dose of 5 mg
0 mg PrednisoneDrug
Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 5 mg Prednisone | Experimental | Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period. Receives: Drug: 5 mg Prednisone |
| 0 mg Prednisone | Experimental | Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period. Receives: Drug: 0 mg Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prednisone Dose Increase for Disease Relapse
Number of participants who's dose of prednisone was increased due to relapse of the GPA
Measured: 6 months
Secondary outcomes (3)
Rates of Disease Flare Sub Types
Rates of GPA disease flare sub types: severe versus non-severe
Measured: 6 months
Safety Outcomes.
Number of serious adverse events during the study.
Measured: 6 months
Protocol Performance at VCRC Centers of Excellence.
Evaluation of data completeness between randomized groups from day 0 through the end of the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Peter A Merkel, MD, MPH, Principal investigator, University of PennsylvaniaJeffery P Krischer, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940094
- Sponsor's protocol ID
- VCRC5526A
- Other IDs
- R01HL115041, U54AR057319
- Acronym
- TAPIR
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2013
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cronholm PF, Applequist J, Krischer J, Fontenot E, Davis T, Burroughs C, McAlear CA, Borchin R, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg SR, Merkel PA; Vasculitis Clinical Research Consortium. A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research. BMC Med Res Methodol. 2024 Oct 18;24(1):244. doi: 10.1186/s12874-024-02352-w.
PubMed 39425055
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach
- ClinicalTrials.gov ID
- NCT01940094
- Acronym / sponsor ID
- TAPIR / VCRC5526A
- Conditions
- Granulomatosis With Polyangiitis
- Keywords
- Granulomatosis with polyangiitis, Wegener's granulomatosis, WG, GPA, ANCA-Associated Vasculitis, AAV, Vasculitis, Prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- 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
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 mg Prednisone | Experimental | Drug: 5 mg PrednisoneSubjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period. |
| 0 mg Prednisone | Experimental | Drug: 0 mg PrednisoneSubjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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.
- Active disease within the prior 12 months (initial presentation or relapse) that at time of active disease required treatment with prednisone >20 mg/day.
- Disease remission at time of enrollment.
- Prednisone dose at time of enrollment of ≥ 5 mg/day and ≤ 20 mg/day.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mg PrednisoneAlso: •5 mg/day glucocorticoids, •5 mg/day prednisone, •5 mg/day steroidsSubjects will remain on daily prednisone dose of 5 mg | Drug | 5 mg Prednisone |
| 0 mg PrednisoneSubjects will taper their prednisone dose from 5 mg per day to 0 mg per day | Drug | 0 mg Prednisone |
Primary outcome
Prednisone Dose Increase for Disease Relapse
Time frame: 6 months
Number of participants who's dose of prednisone was increased due to relapse of the GPA
3 secondary outcomes
Rates of Disease Flare Sub Types
Time frame: 6 months
Safety Outcomes.
Time frame: 6 months
Protocol Performance at VCRC Centers of Excellence.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39425055Cronholm PF, Applequist J, Krischer J, Fontenot E, Davis T, Burroughs C, McAlear CA, Borchin R, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg SR, Merkel PA; Vasculitis Clinical Research Consortium. A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research. BMC Med Res Methodol. 2024 Oct 18;24(1):244. doi: 10.1186/s12874-024-02352-w.
- Vasculitis Clinical Research ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Merkel, MD, MPH principal investigator
University of Pennsylvania
Jeffery P Krischer, PhD principal investigator
University of South Florida
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5 mg Prednisone and 0 mg Prednisone in people with Granulomatosis With Polyangiitis, run by University of Pennsylvania at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prednisone Dose Increase for Disease Relapse (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01940094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.