Trial Outcomes & Findings for Corticosteroid Dosage for Crohn's Disease Flare (NCT NCT02392286)
NCT ID: NCT02392286
Last Updated: 2021-08-09
Results Overview
Number of participants with Harvey Bradshaw Index \< 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. \<5 is determined to be remission.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-08-09
Participant Flow
Participant milestones
| Measure |
Weight-based
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corticosteroid Dosage for Crohn's Disease Flare
Baseline characteristics by cohort
| Measure |
Weight-based
n=7 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=8 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 1 patient in fixed dose group did not return for this assessment.
Number of participants with Harvey Bradshaw Index \< 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. \<5 is determined to be remission.
Outcome measures
| Measure |
Weight-based
n=7 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=7 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Number of Participants in Remission at End of 2 Weeks
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 1 patient in fixed-dose group did not return for this assessment.
Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks
Outcome measures
| Measure |
Weight-based
n=7 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=7 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Number of Participants With Response at End of 2 Weeks
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 1 patient in weight-based group and 2 patients in fixed-dose group did not return for this assessment.
Number of participants with Harvey-Bradshaw Index \<5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week
Outcome measures
| Measure |
Weight-based
n=6 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=6 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Number of Participants With Response or Remission at End of 1 Week
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 2 patients in weight-based group and 1 patient in fixed-dose group did not return for this assessment.
Number of participants with Harvey-Bradshaw Index \<5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks
Outcome measures
| Measure |
Weight-based
n=5 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=7 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Number of Participants With Response or Remission at End of 4 Weeks
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 1 patient in fixed-dose group did not return for this assessment.
Number of participants with Harvey-Bradshaw Index \<5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks
Outcome measures
| Measure |
Weight-based
n=7 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=7 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Number of Participants With Response or Remission at End of 12 Weeks
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 1 patient in fixed dose did not return and did not have any assessment for this outcome after randomization.
Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias.
Outcome measures
| Measure |
Weight-based
n=7 Participants
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=7 Participants
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Number of Participants With Corticosteroid-associated Side Effects
|
5 Participants
|
7 Participants
|
Adverse Events
Weight-based
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Fixed Dose
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weight-based
n=7 participants at risk
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=8 participants at risk
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization for Crohn's disease
|
14.3%
1/7 • Up to 12 weeks.
|
50.0%
4/8 • Up to 12 weeks.
|
Other adverse events
| Measure |
Weight-based
n=7 participants at risk
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
Fixed Dose
n=8 participants at risk
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
|
|---|---|---|
|
Psychiatric disorders
Mood swings
|
28.6%
2/7 • Up to 12 weeks.
|
62.5%
5/8 • Up to 12 weeks.
|
|
Psychiatric disorders
Sleep disturbance
|
57.1%
4/7 • Up to 12 weeks.
|
37.5%
3/8 • Up to 12 weeks.
|
|
Endocrine disorders
Edema
|
14.3%
1/7 • Up to 12 weeks.
|
37.5%
3/8 • Up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
28.6%
2/7 • Up to 12 weeks.
|
12.5%
1/8 • Up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
3/7 • Up to 12 weeks.
|
12.5%
1/8 • Up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
14.3%
1/7 • Up to 12 weeks.
|
37.5%
3/8 • Up to 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place