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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00851565
Date of registration: 24/02/2009
Prospective Registration: Yes
Primary sponsor: Copenhagen University Hospital at Herlev
Public title: Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Scientific title: Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Date of first enrolment: June 2009
Target sample size: 120
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Name:     Mark Ainsworth, M.D., Ph.D. DMSci
Key inclusion & exclusion criteria

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

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Procedure: Measurement of serum infliximab and anti-infliximab antibodies
Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status
Primary Outcome(s)
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 Outcome(s)
Clinical response at week 4, 8, 20 [Time Frame: Week 4, 8, 20]
Days with subjective feeling of disability due to Crohn's disease [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]
Laboratory parameters [Time Frame: Week 12]
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 IBDQ score at week 12. [Time Frame: 12 weeks]
Mean change compared to baseline in PDAI score at week 4, 8, 12, and 20. [Time Frame: 4, 8, 12, 20 weeks]
Mean change compared to baseline in WPAI score at week 12. [Time Frame: 12 weeks]
Serious adverse drug reactions [Time Frame: week 12]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aase and Ejnar Danielsens Foundation
Beckett Foundation
Biomonitor A/S
Danish Colitis-Crohn Society
Danish Medical Association Research Fund
Frode V. Nyegaard and wife’s Foundation
Health Science Research Foundation of Region of Copenhagen
Herlev Hospital Research Council
Lundbeck Foundation
P. Carl Petersens Fund
Prometheus Inc.
the Danish Biotechnology Program
The Danish Institute for Health Services Research
Ethics review
Results available:
Date Posted:
Date Completed:
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