Pouchitis, Ulcerative Colitis
Conditions
Keywords
IPAA, Pouchitis, Ulcerative colitis, Pouch, Adalimumab, Humira
Brief summary
This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis. The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis. Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. It is a double-blinded randomized placebo controlled study.
Interventions
DRUGAdalimumab
DRUGPlacebo
Sponsors
Odense University Hospital
University of Southern Denmark
Hvidovre University Hospital
Aarhus University Hospital
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 | Description |
|---|---|---|
| Clinical response on treatment with Adalimumab | 12 weeks | The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira). Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement after 12 weeks of treatment | 12 weeks | The number of patients with a clinical improvement (PDAI reduction ≥ 2)at week 12 See the description of clinical improvement and PDAI under primary endpoint |
| Clinical remission after 12 weeks | 12 weeks | The number of patients with pouchitis in remission at week 12 (total PDAI ≤4) |
| Endoscopic and histologic response after treatment with Adalimumab | 12 weeks | Effect (reduction in PDAI)of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis Endoscopical and histological activity is defined from PDAI (pouchitis disease activity index). Endoscopically the presence of Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates or Ulceration, gives 1 point each (max 6 points). Histological the presence of polymorphic nuclear leukocyte infiltration and ulceration each gives 1-3 points regarding severity (max 6 points) |
Countries
Denmark
Outcome results
None listed