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NCT01933724 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Vasculitis and Granulomatosis With Polyangiitis, sponsored by University of South Florida.

Active
Registry status
Phase 3
Development phase
12
Enrollment target
1
Study location

NCT01933724 is a Phase 3 study of Vasculitis and Granulomatosis With Polyangiitis that is active but no longer recruiting, run by University of South Florida. The registered enrollment target is 12 participants, below the 27,318-participant average among 11 other Vasculitis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01933724, a Phase 3 study of Vasculitis and Granulomatosis With Polyangiitis, is active but no longer recruiting, sponsored by University of South Florida.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
12 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG 5 mg prednisone
  • DRUG 0 mg prednisone

Study Locations (1)

Florida

  • University of South Florida TAPIR Study Team - Tampa

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2014-02-17
Est. Completion 2025-12-31
Phase Phase 3

Sponsor

University of South Florida

252 total trials

What the Registry Record Tells You About NCT01933724

The ClinicalTrials.gov registry entry for NCT01933724 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 27,318-participant average among 11 other Vasculitis trials with a reported enrollment target (100% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Vasculitis appearing as the primary indexed condition, and to 2 interventions - of which 5 mg prednisone is the first listed.

NCT01933724 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01933724 about?

NCT01933724 is a clinical study titled "The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach". 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 pred...

What is the current status of trial NCT01933724?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2014-02-17. Estimated completion is 2025-12-31.

What conditions does trial NCT01933724 study?

This clinical trial studies the following conditions: Vasculitis, Granulomatosis With Polyangiitis, Wegener Granulomatosis.

What interventions are being tested in trial NCT01933724?

The interventions under investigation include: 5 mg prednisone (DRUG), 0 mg prednisone (DRUG).

Who is sponsoring clinical trial NCT01933724?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01933724 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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