Trial Outcomes & Findings for The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach (NCT NCT01940094)
NCT ID: NCT01940094
Last Updated: 2026-08-06
Results Overview
Number of participants who's dose of prednisone was increased due to relapse of the GPA
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
159 participants
Primary outcome timeframe
6 months
Results posted on
2026-08-06
Participant Flow
Of 159 enrolled participants, 143 met the criteria for randomisation and were randomised 1:1 per protocol.
Participant milestones
| Measure |
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.
|
5 mg Prednisone
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
72
|
|
Overall Study
COMPLETED
|
71
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach
Baseline characteristics by cohort
| Measure |
0 mg Prednisone
n=71 Participants
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 Participants
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 Years
n=20 Participants
|
58.4 Years
n=20 Participants
|
58.4 Years
n=40 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
68 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
75 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=20 Participants
|
63 Participants
n=20 Participants
|
126 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=20 Participants
|
65 Participants
n=20 Participants
|
127 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants who's dose of prednisone was increased due to relapse of the GPA
Outcome measures
| Measure |
0 mg Prednisone
n=71 Participants
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 Participants
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Prednisone Dose Increase for Disease Relapse
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsRates of GPA disease flare sub types: severe versus non-severe
Outcome measures
| Measure |
0 mg Prednisone
n=71 Participants
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 Participants
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Rates of Disease Flare Sub Types
Severe flare
|
1 Participants
|
0 Participants
|
|
Rates of Disease Flare Sub Types
Non-severe flare
|
10 Participants
|
3 Participants
|
|
Rates of Disease Flare Sub Types
No flare
|
60 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of serious adverse events during the study.
Outcome measures
| Measure |
0 mg Prednisone
n=71 Participants
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 Participants
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Safety Outcomes.
|
5 Serious Adverse Events
|
1 Serious Adverse Events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data compliance was calculated as the proportion of expected submissions that were received. Compliance (%) = (number of submitted data entries ÷ total number of expected data entries) × 100. The reported values represent overall compliance percentages within each study group and are not participant-level means.
Evaluation of data completeness between randomized groups from day 0 through the end of the study.
Outcome measures
| Measure |
0 mg Prednisone
n=71 Participants
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 Participants
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Protocol Performance at VCRC Centers of Excellence.
|
98.4 Participant Data Compliance (%)
|
98.6 Participant Data Compliance (%)
|
Adverse Events
0 mg Prednisone
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
5 mg Prednisone
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0 mg Prednisone
n=71 participants at risk
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 participants at risk
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Infections and infestations
Bronchial infection
|
1.4%
1/71 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
0.00%
0/72 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
|
Infections and infestations
Infections and infestations - other
|
1.4%
1/71 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
1.4%
1/72 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
|
Infections and infestations
Bladder infection
|
1.4%
1/71 • Number of events 2 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
0.00%
0/72 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
|
Eye disorders
Eye disorders
|
1.4%
1/71 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
0.00%
0/72 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
Other adverse events
| Measure |
0 mg Prednisone
n=71 participants at risk
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
|
5 mg Prednisone
n=72 participants at risk
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
|
|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
5.6%
4/71 • Number of events 4 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
2.8%
2/72 • Number of events 2 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
|
Infections and infestations
Lung infection
|
1.4%
1/71 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
0.00%
0/72 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
|
Infections and infestations
Skin infection
|
1.4%
1/71 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
0.00%
0/72 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
|
Infections and infestations
Infections - other
|
0.00%
0/71 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
1.4%
1/72 • Number of events 1 • From baseline to end of follow-up (From baseline until end of study which could be up to 8 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place