Study Summary
This trial is testing whether it's better to taper off or stop using prednisone, a medication used to treat inflammation.
Eligible Conditions
- Wegener's Granulomatosis
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 6 months
6 months
Protocol performance at VCRC Centers of Excellence.
Safety outcomes.
Time to disease flare.
Measured at baseline and end of the study
Health-related quality of life survey
Month 3
Health-related quality of life surveys
Six months
Physician decision to increase glucocorticoids for disease relapse.
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
5 mg Prednisone
1 of 2
0 mg Prednisone
1 of 2
Experimental Treatment
159 Total Participants · 2 Treatment Groups
Primary Treatment: 5 mg Prednisone · No Placebo Group · Phase 3
5 mg Prednisone
Drug
Experimental Group · 1 Intervention: 5 mg Prednisone · Intervention Types: Drug0 mg Prednisone
Drug
Experimental Group · 1 Intervention: 0 mg Prednisone · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
168 Previous Clinical Trials
124,352 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,591 Previous Clinical Trials
46,945,788 Total Patients Enrolled
Office of Rare Diseases (ORD)NIH
43 Previous Clinical Trials
12,287 Total Patients Enrolled
Rare Diseases Clinical Research NetworkNETWORK
67 Previous Clinical Trials
18,643 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
1,841 Previous Clinical Trials
41,126,257 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
447 Previous Clinical Trials
1,072,301 Total Patients Enrolled
Jeffery P Krischer, PhDPrincipal InvestigatorUniversity of South Florida
Peter A Merkel, MD, MPHPrincipal InvestigatorUniversity of Pennsylvania
9 Previous Clinical Trials
2,044 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Nasal inflammation is a condition that results in the development of painful or painless oral ulcers or purulent or bloody nasal discharge.
An abnormal chest radiograph is defined as the presence of nodules, fixed infiltrates, or cavities.
Active urinary sediment is defined as microscopic hematuria (more than 5 red blood cells per high power field) or red blood cell casts.
A condition in which histologic changes show granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area.
Patients who are ANCA negative are still eligible for this study if they meet the criteria above and are felt to have GPA.
The positive anti-neutrophil cytoplasmic antibody (ANCA) test is specific for proteinase-3, and it is measured by enzyme-linked immunoassay.
The person has active disease that required treatment with prednisone more than 20 mg/day within the past 12 months.
The patient was in remission from their disease at the time of enrollment.
The prednisone dose at the time of enrollment is ≥ 5 mg/day and ≤ 20 mg/day.
People who are 18 years or older are eligible to participate in this study.
Who else is applying?
What site did they apply to?
| St. Joseph's Healthcare | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments