Trial Outcomes & Findings for NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease (NCT NCT00936585)
NCT ID: NCT00936585
Last Updated: 2016-01-11
Results Overview
Changes in immunological parameters in blood and lamina propria immune cells
TERMINATED
NA
2 participants
Baseline, 6 weeks
2016-01-11
Participant Flow
Patients were recruited using advertisements and from patient database of Crohn's patients seen at the NIH CC.
All patients who were enrolled in the main study to receive study drug were eligible for the sub-study. There was no randomization.
Participant milestones
| Measure |
Immunologic Monitoring
All patients who were enrolled in the main study participated in the NIH sub study and underwent a colonoscopy and blood draw for research specimens for immunologic monitoring before and after study drug administration
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease
Baseline characteristics by cohort
| Measure |
Immunologic Monitoring
n=2 Participants
Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 0.71 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: All patients in the study were enrolled; not enough patients were enrolled to get enough data to analyze - THERE IS NO DATA as the samples were not processed because not enough patients were enrolled to make any comparison.
Changes in immunological parameters in blood and lamina propria immune cells
Outcome measures
Outcome data not reported
Adverse Events
Colonoscopy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Yao, MD
National Institute of Allergy and Infectious Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place