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

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

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.

Sponsors & Collaborators

• Aase and Ejnar Danielsens Foundation

  collaborator OTHER

• Beckett Foundation

  collaborator OTHER

• the Danish Biotechnology Program

  collaborator UNKNOWN

• Colitis-Crohn Foreningen

  collaborator OTHER

• Danish Medical Association

  collaborator OTHER

• Frode V. Nyegaard and wife's Foundation

  collaborator UNKNOWN

• Health Science Research Foundation of Region of Copenhagen

  collaborator UNKNOWN

• Herlev Hospital Research Council

  collaborator UNKNOWN

• Lundbeck Foundation

  collaborator OTHER

• P. Carl Petersens Fund

  collaborator OTHER

• Biomonitor A/S

  collaborator UNKNOWN

• Prometheus Inc.

  collaborator INDUSTRY

• The Danish Institute for Health Services Research

  collaborator UNKNOWN

• Copenhagen University Hospital at Herlev

  lead OTHER

Principal Investigators

• Mark Ainsworth, M.D., Ph.D. DMSci

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2012-02-29

Completion

2014-02-28

Countries

• Denmark

Study Locations