Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0 Level: PT Classification code 10036463 Term: Pouchitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Humira 40 mg solution for injection in pre-filled syringes
Product Name: Humira
Product Code: EMEA/H/C/000481
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Operated with proctocolectomy and construction of an IPAA • Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria. • Diagnosed with chronic pouchitis as defined above • PDAI = 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3 • Age >18 years • Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites • Serology negative for chronic hepatitis B • Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test) • Signed informed consent 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 24 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with glucocorticoids within the last 4 weeks • Diagnosed with Crohn’s disease • Need of an interpreter or if patients do not understand oral or written information. • Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch • Abuse of medicine, alcohol or drugs • Ongoing treatment with NSAID (non steroid anti inflammatory drug) • Pregnancy or nursing • A diverting stoma • Malignancy or other severe chronic disease or expected longevity less than one year • Patients diagnosed with immune deficiency • Ongoing infectious disease • Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis. ;Secondary Objective: Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. ;Primary end point(s): The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically Pouchitis Disease Activity Index (PDAI) = 2 at any time within the 12 weeks of treatment with adalimumab (Humira). ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) The number of patients with a clinical improvement at week 12 (2) The number of patients with pouchitis in remission at week 12 (total PDAI <=4) (3) Effect of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Denmark
Contacts
Public ContactMie Dilling Kjaer
Odense University Hospital
Outcome results
None listed