Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments measurement of serum infliximab and anti-infliximab antibodies, treatment according to current standards without knowledge of serum infliximab and anti-infliximab ab status
Phase phase 4
Sponsor Copenhagen University Hospital at Herlev
Collaborator Aase and Ejnar Danielsens Foundation
Start date June 2009
End date February 2012
Trial size 120 participants
Trial identifier NCT00851565, 01MA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Patients with Crohn's disease with secondary loss of response to infliximab.
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: Low s-infliximab in the presence of anti-infliximab Ab: Adalimumab 80 mg s.c. followed by 40 mg every 2 weeks. Low s-infliximab without anti-infliximab Ab: Infliximab 10 mg/kg i.v. every 8 weeks. High s-infliximab without anti-infliximab Ab: Stop infliximab treatment. Review history. Steroids or surgery. High s-infliximab in the presence of anti-infliximab Ab: Same as number 3.
(Active Comparator)
Patients with Crohn's disease with secondary loss of response to infliximab.
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.

Primary Outcomes

Measure
Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease.
time frame: 12 weeks
Total expenses related to Crohn's disease during the study (inclusion to week 12).
time frame: 12 weeks

Secondary Outcomes

Measure
Mean change compared to baseline in WPAI score at week 12.
time frame: 12 weeks
Mean change compared to baseline in IBDQ score at week 12.
time frame: 12 weeks
Mean change compared to baseline in CDAI score at week 4,8, 12,20.
time frame: 4, 8, 12, 20 weeks
Mean change compared to baseline in PDAI score at week 4, 8, 12, and 20.
time frame: 4, 8, 12, 20 weeks
Clinical response at week 4, 8, 20
time frame: Week 4, 8, 20
Laboratory parameters
time frame: Week 12
Days with subjective feeling of disability due to Crohn's disease
time frame: week 12
Serious adverse drug reactions
time frame: week 12
Expenses related to Crohn's diseae at week 20
time frame: week 20
Expenses related to Crohn's disease compared to change in CDAI-score (luminal disease) or PDAI-score (fistulizing disease), and IBD-score at week 12 and 20
time frame: week 12 and 20

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient must be able to understand the information given to him/her and give written informed consent. 2. Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic and/or histological evidence according to international criteria) . 3. Age minimum 18 years. 4. Previous good response to at least 3 doses (5mg/kg) of infliximab (as judged by the treating physician). 5. Loss of response to standard doses of infliximab (as judged by the treating physician). 6. Last infliximab infusion given at least 4 weeks before inclusion. 7. For patients with luminal disease, the CDAI should be above 220 points at inclusion. 8. For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present. Exclusion Criteria: 1. Any contraindication to continued infliximab treatment 2. Short bowel syndrome 3. Bowel resection within 12 weeks of inclusion. 4. Current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease. 5. Pregnancy 6. History of alcohol or drug abuse within the prior year 7. Patients who do not meet concomitant medication criteria. 8. Any other condition, which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.

Additional Information

Official title Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Principal investigator Mark Ainsworth, M.D., Ph.D. DMSci
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Copenhagen University Hospital at Herlev.