Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Copenhagen University Hospital at Herlev
With
Aase and Ejnar Danielsens Foundation
Beckett Foundation
the Danish Biotechnology Program
Colitis-Crohn Foreningen
Danish Medical Association
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
Biomonitor A/S
Prometheus Inc.
The Danish Institute for Health Services Research
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
