Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2009-009926-94-DK
• Date of registration: 25/02/2009
• Prospective Registration: Yes
• Primary sponsor: Department of medical gastroenterology, Herlev Hospital
• 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: 26/03/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009926-94
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Treatment with and without knowledge of serum infliximab and anti-infliximab antibodies
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Denmark

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 criterias) .
3. 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. For patients with luminal disease, the CDAI should be above 220 points at inclusion.
7. For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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 juegment would make the patient unsuitable for inclusion in the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Crohns diseases failing treatment with infliximab
MedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Concentrate for solution for infusion

Trade Name: Humira
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

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

Main Objective: 1) 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.
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.

2) Total expenses related to Crohn's disease during the study (inclusion to week 12).
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.

Primary end point(s): 1) Proportion of patients with response (CDAI decrease of 70 or more for luminal disease or reduction of 50 percent or more from base line in the number of draining fistulas) at week 12
2) Total Crohn related expenses during 12 week study period

Secondary ID(s)

01MA