Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's (Adafi)

April 16, 2012 updated by: Foundation for Liver Research

Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin

To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • AMC
      • Amsterdam, Netherlands
        • VU
      • Den Haag, Netherlands
        • Haga Ziekenhuis
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Dordrecht, Netherlands
        • Albert Schweitzer ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • UMC Gronigen
      • Leiden, Netherlands
        • LUMC
      • Maastricht, Netherlands
        • AZ Maastricht
      • Nieuwegein, Netherlands
        • St Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • UMC Radboud
      • Rotterdam, Netherlands
        • Erasmus MC
      • Utrecht, Netherlands
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • proven Crohn's disease
  • Single or multiple draining perianal fistulas

Exclusion Criteria:

  • Abscesses
  • Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
  • active viral infection
  • significate cardiovascular dysfunction
  • Pregnancy, Lactation
  • Surgical bowel resection to be expected within 6 months
  • Positive stool culture for enteric pathogens
  • Total parental nutrition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Adalimumab
Drug: adalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
Other Names:
  • Humira
PLACEBO_COMPARATOR: 2
ciprofloxacin
Drug: ciprofloxacin
12 weeks; daily 2 x 500mg
Other Names:
  • Cipro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
Time Frame: 12 week
12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients in remission
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Liver Research

Investigators

  • Principal Investigator: C.J. van der Woude, MD PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (ESTIMATE)

August 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBD 08-01
  • EudraCT#: 2007-005832-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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