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Adalimumab in the Treatment of Chronic Pouchitis (ADAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Odense University Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Hvidovre University 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: October 14, 2014
Last verified: October 2014
  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:


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: January 2016
Estimated Primary Completion Date: September 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670240

Contacts
Contact: Mie D 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 D Kjaer, MD    + 45 29913103    mie.kjaer@rsyd.dk   
Principal Investigator: Jens Kjeldsen, phd         
Sub-Investigator: Mie D Kjaer, MD         
Sub-Investigator: Niels Qvist, Dr.med, prof         
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Hvidovre University 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: October 14, 2014
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:
Ileal Diseases
Colitis
Colitis, Ulcerative
Pouchitis
Ulcer
Colonic Diseases
Digestive System Diseases
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Ileitis
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014