search
Back to results

Adalimumab in the Treatment of Chronic Pouchitis (ADAP)

Primary Purpose

Ulcerative Colitis, Pouchitis

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Adalimumab
Placebo
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring IPAA, Pouchitis, Ulcerative colitis, Pouch, Adalimumab, Humira

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Adalimumab

Placebo

Arm Description

Every second week, mg: 160-80-40-40-40-40 12 weeks in all

Given as the active comparator, every second week

Outcomes

Primary Outcome Measures

Clinical response on treatment with Adalimumab
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 Outcome Measures

Clinical improvement after 12 weeks of treatment
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
The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)
Endoscopic and histologic response after treatment with Adalimumab
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)

Full Information

First Posted
August 8, 2012
Last Updated
January 27, 2016
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Hvidovre University Hospital, Aarhus University Hospital, AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT01670240
Brief Title
Adalimumab in the Treatment of Chronic Pouchitis
Acronym
ADAP
Official Title
Adalimumab (Humira) in the Treatment of Chronic Pouchitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Hvidovre University Hospital, Aarhus University Hospital, AbbVie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Pouchitis
Keywords
IPAA, Pouchitis, Ulcerative colitis, Pouch, Adalimumab, Humira

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Given as the active comparator, every second week
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical response on treatment with Adalimumab
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical improvement after 12 weeks of treatment
Description
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
Time Frame
12 weeks
Title
Clinical remission after 12 weeks
Description
The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)
Time Frame
12 weeks
Title
Endoscopic and histologic response after treatment with Adalimumab
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kjeldsen, Phd
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Adalimumab in the Treatment of Chronic Pouchitis

We'll reach out to this number within 24 hrs