Clinical trial NCT01670240: Adalimumab in the Treatment of Chronic Pouchitis
Official title: Adalimumab (Humira) in the Treatment of Chronic Pouchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Pouchitis
Keywords: IPAA
Pouchitis
Ulcerative colitis
Pouch
Adalimumab
Humira
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Hvidovre University Hospital
name: Aarhus University Hospital
name: AbbVie
First posted: 2012-08-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

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

Primary outcomes:
measure: Clinical response on treatment with Adalimumab
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical improvement after 12 weeks of treatment
timeFrame: 12 weeks
measure: Clinical remission after 12 weeks
timeFrame: 12 weeks
measure: Endoscopic and histologic response after treatment with Adalimumab
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jens Kjeldsen, Phd
role: PRINCIPAL_INVESTIGATOR
References: