Trial Outcomes & Findings for Apremilast in the Treatment of Uveitis (NCT NCT00889421)
NCT ID: NCT00889421
Last Updated: 2014-07-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
6 months
Results posted on
2014-07-08
Participant Flow
Participant milestones
| Measure |
Treatment
Patient receiving apremilast.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment
Patient receiving apremilast.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Apremilast in the Treatment of Uveitis
Baseline characteristics by cohort
| Measure |
Treatment
n=3 Participants
Patient receiving apremilast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 monthsOutcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=3 participants at risk
Patient receiving apremilast.
|
|---|---|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place