Trial Outcomes & Findings for Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis (NCT NCT02438410)
NCT ID: NCT02438410
Last Updated: 2022-05-04
Results Overview
Total number of participants to be colectomy free at 3 months
Recruitment status
COMPLETED
Target enrollment
13 participants
Primary outcome timeframe
3 month
Results posted on
2022-05-04
Participant Flow
Participant milestones
| Measure |
Hospitalized Patients Receiving Infliximab
Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hospitalized Patients Receiving Infliximab
n=13 Participants
Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
|
Age, Continuous
|
34 years
n=13 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 3 monthTotal number of participants to be colectomy free at 3 months
Outcome measures
| Measure |
Hospitalized Patients Receiving Infliximab
n=13 Participants
Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
|
|---|---|
|
Number of Participants to be Colectomy Free at 3 Months
|
6 Participants
|
PRIMARY outcome
Timeframe: 3 monthsBiomarkers markers ESR, CRP, TNF levels, and hemoglobin will be collected to assess relationships between colectomy an other potential biomarkers
Outcome measures
| Measure |
Hospitalized Patients Receiving Infliximab
n=13 Participants
Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
|
|---|---|
|
Number of Participants With the Need for Colectomy Assessed by Biomarker Levels
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 monthTotal number of participants to be colectomy free at 1 month
Outcome measures
| Measure |
Hospitalized Patients Receiving Infliximab
n=13 Participants
Patients hospitalized and scheduled to receive clinically indicated infliximab due to flare of moderate to severe UC.
|
|---|---|
|
Number of Participants to be Colectomy Free at 1 Month
|
11 Participants
|
Adverse Events
Hospitalized Patients Receiving Infliximab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place