NCT00851565

Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare treatment outcome in patients with Crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (Ab) status.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
PROCEDURE	Measurement of serum infliximab and anti-infliximab antibodies	In the intervention group treatment of patients with Crohn's disease with secondary loss of response to infliximab is based on serum infliximab and anti-infliximab Ab levels according to following algorithm: 1. Low s-infliximab in the presence of anti-infliximab Ab: Adalimumab 80 mg s.c. followed by 40 mg every 2 weeks. 2. Low s-infliximab without anti-infliximab Ab: Infliximab 10 mg/kg i.v. every 8 weeks. 3. High s-infliximab without anti-infliximab Ab: Stop infliximab treatment. Review history. Steroids or surgery. 4. High s-infliximab in the presence of anti-infliximab Ab: Same as number 3.
PROCEDURE	Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status	In the control group patients with Crohn's disease with secondary loss of response to infliximab is treated according to current standard of care which is to increase dose of infliximab to 5 mg/kg every 4 weeks without knowledge of serum infliximab levels and anti-infliximab Ab status.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-02-01
• Completion: 2014-02-01
• First posted: 2009-02-26
• Last updated: 2011-11-28

Locations

8 sites across 1 country: Denmark