Status:
UNKNOWN
Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Lead Sponsor:
Copenhagen University Hospital at Herlev
Collaborating Sponsors:
Aase and Ejnar Danielsens Foundation
Beckett Foundation
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 standar...
Eligibility Criteria
Inclusion
- Patient must be able to understand the information given to him/her and give written informed consent.
- Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic and/or histological evidence according to international criteria) .
- Age minimum 18 years.
- Previous good response to at least 3 doses (5mg/kg) of infliximab (as judged by the treating physician).
- Loss of response to standard doses of infliximab (as judged by the treating physician).
- Last infliximab infusion given at least 4 weeks before inclusion.
- For patients with luminal disease, the CDAI should be above 220 points at inclusion.
- For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present.
Exclusion
- Any contraindication to continued infliximab treatment
- Short bowel syndrome
- Bowel resection within 12 weeks of inclusion.
- Current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- Pregnancy
- History of alcohol or drug abuse within the prior year
- Patients who do not meet concomitant medication criteria.
- Any other condition, which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00851565
Start Date
June 1 2009
End Date
February 1 2014
Last Update
November 28 2011
Active Locations (8)
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1
Dept of Medical Gastroenterology, Ålborg University Hospital
Aalborg, Denmark, 9000
2
Dept of Hepatology and Medical Gastroenterology, Århus University Hospital
Aarhus, Denmark, 8000
3
Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
4
Esbjerg Hospital
Esbjerg, Denmark, 6700