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Adalimumab in the Treatment of Chronic Pouchitis (ADAP)

This study is currently recruiting participants.
Verified April 2013 by Odense University Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Hvidovre Hospital
Aarhus University Hospital
AbbVie
Information provided by (Responsible Party):
Mie Dilling Kjaer, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01670240
First received: August 8, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Pouchitis
 Drug: Adalimumab
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Clinical response on treatment with Adalimumab [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)

  • Endoscopic and histologic response after treatment with Adalimumab [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 24
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
 Drug: Adalimumab
Other Name: Humira
Placebo Comparator: Placebo
Given as the active comparator, every second week
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670240

Contacts
Contact: Mie Dilling Kjaer, MD + 45 29913103 mie.kjaer@rsyd.dk
Contact: Jens Kjeldsen, Ph.d +45 65412765 jens.kjeldsen@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mie Dilling Kjaer, MD     + 45 29913103     mie.kjaer@rsyd.dk    
Principal Investigator: Jens Kjeldsen, phd            
Sub-Investigator: Mie Dilling Kjaer, MD            
Sub-Investigator: Niels Qvist, Dr.med, professor            
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Hvidovre Hospital
Aarhus University Hospital
AbbVie
Investigators
Principal Investigator: Jens Kjeldsen, Phd Odense University Hospital
  More Information

No publications provided

Responsible Party: Mie Dilling Kjaer, Principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01670240     History of Changes
Other Study ID Numbers: 2011-004268-31
Study First Received: August 8, 2012
Last Updated: April 30, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
IPAA
Pouchitis
Ulcerative colitis
 Pouch
Adalimumab
Humira

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Pouchitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
 Pathologic Processes
Ileitis
Enteritis
Ileal Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013