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Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
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.
Details
| Lead sponsor | Copenhagen University Hospital at Herlev |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2009-06 |
| Completion | 2014-02 |
Conditions
- Crohn's Disease
Interventions
- Measurement of serum infliximab and anti-infliximab antibodies
- Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status
Primary outcomes
- 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.
Countries
Denmark