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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 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.
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.
Interventions
- OTHER Immunologic Monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00936585
The ClinicalTrials.gov registry entry for NCT00936585 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Immunologic Monitoring is the first listed.
NCT00936585 reports 0 study locations.
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.
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