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NCT00936585 · ClinicalTrials.gov registry record · NA
NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT00936585: Clinical Trial NA study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00936585 is a NA study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00936585, a NA study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human interleukin-17A) for moderate to severe Crohn's disease. Recent data suggests that interleukin-17 (IL-17) is an important mediator of inflammation in certain animal models of Crohn's disease, and treatment aimed at blocking the IL-23-IL-17 axis can ameliorate the inflammatory changes. In addition, elevated expression of IL-l7 has been found in the gut tissue of patients with active Crohn's disease. This substudy will measure changes in cytokine production, relevant RNA expression, and immune cell populations (in the periphery and lamina propria) for correlation with clinical outcomes in order to explore the mechanisms of therapeutic response.
Primary Outcome
Changes in immunological parameters in blood and lamina propria immune cells
Interventions
- OTHER Immunologic Monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-02 |
| Phase | NA |
Why NCT00936585 stopped before completion
NCT00936585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Immunologic Monitoring is the first listed.
NCT00936585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00936585 about?
NCT00936585 is a clinical study titled "NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease". The objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human interleukin-17A) for moderate to severe Crohn's disease. Recent data suggests that interleukin-17 (IL-17) is an import...
What is the current status of trial NCT00936585?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2009-07. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00936585?
The interventions under investigation include: Immunologic Monitoring (OTHER).
Who is sponsoring clinical trial NCT00936585?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00936585's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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