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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 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 3 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02413047
The ClinicalTrials.gov registry entry for NCT02413047 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methotrexate is the first listed.
NCT02413047 reports 0 study locations.
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.
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