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

Phase 4

• Conditions: Crohn's Disease
• Interventions: 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

• Registration Number: NCT00851565
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Study Start: 2009-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28
• Primary Completion: 2012-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Measurement of serum infliximab and anti-infliximab antibodies	Patients with Crohn's disease with secondary loss of response to infliximab.
2	Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status	Patients with Crohn's disease with secondary loss of response to infliximab.

Primary Outcome Measures

Name	Time	Method
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.	12 weeks	Clinical response rates at week 12 should be non-inferior in the intervention group as compared to the control group.; Both primary end-points should be met in order to declare the primary end-points succesfully archived.
Total expenses related to Crohn's disease during the study (inclusion to week 12).	12 weeks	Crohn related expenses at week 12 should be less in the intervention group as compared to the control group.; Both primary end-points should be met in order to declare the primary end-points succesfully archived.

Secondary Outcome Measures

Name	Time	Method
Mean change compared to baseline in WPAI score at week 12.	12 weeks
Mean change compared to baseline in IBDQ score at week 12.	12 weeks
Mean change compared to baseline in CDAI score at week 4,8, 12,20.	4, 8, 12, 20 weeks
Mean change compared to baseline in PDAI score at week 4, 8, 12, and 20.	4, 8, 12, 20 weeks
Clinical response at week 4, 8, 20	Week 4, 8, 20	Clinical response is defined as decrease of 70 in CDAI (luminal disease) or 50% reduction of active fistulas (fistulizing disease).
Laboratory parameters	Week 12	Change in laboratory parameters (hemoglobin, crp, albumin) from inclusion to week 12.
Days with subjective feeling of disability due to Crohn's disease	week 12	Total number of days with subjective feelinhg of disability due to Crohn's disease from inclusion to week 12.
Serious adverse drug reactions	week 12	Total number of serious adverse drug reactions from inclusion to week 12.
Expenses related to Crohn's diseae at week 20	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	week 12 and 20

Trial Locations

Locations (8)

Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Herlev University Hospital; 🇩🇰 Herlev, Denmark

Department of Gastroenterology, Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark

Dept of Medical Gastroenterology, Ålborg University Hospital; 🇩🇰 Ålborg, Denmark

Dept of Hepatology and Medical Gastroenterology, Århus University Hospital; 🇩🇰 Århus, Denmark

Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Department of Medical Gastroenterology, Køge University Hospital; 🇩🇰 Køge, Denmark

Dept of Medical Gastroenterology, Odense University Hospital; 🇩🇰 Odense, Denmark