NCT01670240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

3.1 years

First QC Date

August 8, 2012

Last Update Submit

January 27, 2016

Conditions

Ulcerative ColitisPouchitis

Keywords

IPAAPouchitisUlcerative colitisPouchAdalimumabHumira

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 weeks

Secondary Outcomes (3)

  • Clinical improvement after 12 weeks of treatment

    12 weeks

  • Clinical remission after 12 weeks

    12 weeks

  • Endoscopic and histologic response after treatment with Adalimumab

    12 weeks

Study Arms (2)

Adalimumab

ACTIVE COMPARATOR

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

Drug: Adalimumab

Placebo

PLACEBO COMPARATOR

Given as the active comparator, every second week

Drug: Placebo

Interventions

AdalimumabDRUG
Also known as: Humira
Adalimumab
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Colitis, UlcerativePouchitis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesIleitisEnteritisIleal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jens Kjeldsen, Phd

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 22, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

DK(1)