Adalimumab (Humira) in the treatment of chronic pouchitis

• Register: EUCTR
• Last refreshed on: 10 August 2021
• Main ID: EUCTR2011-004268-31-DK
• Date of registration: 21/11/2011
• Prospective Registration: Yes
• Primary sponsor: Odense University Hospital
• Public title: Adalimumab (Humira) in the treatment of chronic pouchitis
• Scientific title: Adalimumab (Humira) in the treatment of chronic pouchitis
• Date of first enrolment: 13/12/2011
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004268-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Mie Dilling Kjaer
• Affiliation: Odense University Hospital

• Name: Mie Dilling Kjaer
• Affiliation: Odense University Hospital

Key inclusion & exclusion 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:
• 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



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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

Intervention(s)

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: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

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).

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.

Secondary Outcome(s)

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

Secondary ID(s)

20110118

Source(s) of Monetary Support

Odense University Hospital

Ethics review

Status: Approved
Approval date: 23/09/2011
Contact:

Results

• Results available: Yes
• Date Posted: 29/06/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004268-31/results