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NCT02413047 · ClinicalTrials.gov registry record · NA
Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT02413047: Clinical Trial NA study, sponsored by Indiana University.
NCT02413047 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 3 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
NCT02413047, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
The immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory bowel disease (IBD) is an important cause of loss of response to therapy that may lead to escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI) or to adalimumab (ATA) and cause this loss of response, also known as a secondary loss of response. An alternative approach is the addition of immunomodulator (IM) therapy to counteract the antibody response and regain efficacy of the biologic medication. The investigators' goal is to treat patients' who have lost response to adalimumab or infliximab with an immunomodulator with the goal of eliminating the circulating antibodies to the anti-TNF and restoring efficacy.
Primary Outcome
The Harvey-Bradshaw index (HBI) is a simplified version of the CDAI to foster a systematic collection of clinical data related to Crohn's disease. The index considers five parameters, exclusively clinical; patient well-being, abdominal pain, number of liquid or soft stools, abdominal mass, and complications.
Interventions
- DRUG Methotrexate
- DRUG Azathioprine
- DRUG 6 mercaptopurine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-02 |
| Phase | NA |
Why NCT02413047 stopped before completion
NCT02413047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 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 3 interventions - of which Methotrexate is the first listed.
NCT02413047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02413047 about?
NCT02413047 is a clinical study titled "Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator". The immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory bowel disease (IBD) is an important cause of loss of response to therapy that may lead to escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI) or to adalimumab (ATA) and ...
What is the current status of trial NCT02413047?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2015-05. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02413047?
The interventions under investigation include: Methotrexate (DRUG), Azathioprine (DRUG), 6 mercaptopurine (DRUG).
Who is sponsoring clinical trial NCT02413047?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02413047's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 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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