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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

August 8, 2012
April 30, 2013
August 2012
June 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01670240 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Adalimumab in the Treatment of Chronic Pouchitis
Adalimumab (Humira) in the Treatment of Chronic Pouchitis

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ulcerative Colitis
  • Pouchitis
  • Drug: Adalimumab
    Other Name: Humira
  • Drug: Placebo
  • Active Comparator: Adalimumab
    Every second week, mg: 160-80-40-40-40-40 12 weeks in all
    Intervention: Drug: Adalimumab
  • Placebo Comparator: Placebo
    Given as the active comparator, every second week
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
September 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mie Dilling Kjaer, MD + 45 29913103 mie.kjaer@rsyd.dk
Contact: Jens Kjeldsen, Ph.d +45 65412765 jens.kjeldsen@rsyd.dk
Denmark
 
NCT01670240
2011-004268-31
Yes
Mie Dilling Kjaer, Odense University Hospital
Odense University Hospital
  • University of Southern Denmark
  • Hvidovre Hospital
  • Aarhus University Hospital
  • AbbVie
Principal Investigator: Jens Kjeldsen, Phd Odense University Hospital
Odense University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP