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Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

NCT02413047 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-11-04

Study results available
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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.

Conditions

Interventions

DRUG

Azathioprine

Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.

DRUG

6 mercaptopurine

Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran

DRUG

Methotrexate

Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Matthew Bohm, DO · IndianaU IRB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02413047 on ClinicalTrials.gov