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

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.

Timeline

Start

2015-05

Primary completion

2018-02

Completion

2018-02

Outcome

Outcome not reported

Stopped (Enrollment): “physician decision to stop study early due to low enrollment”

Drugs

Indications