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CompletedNCT00736983AdafiUpdated Apr 17, 2012

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

A Phase 3 interventional study of adalimumab and ciprofloxacin in Crohn's Disease With Perianal Fistulas, sponsored by Foundation for Liver Research. Completed at 13 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-04-17.

Sponsored by Foundation for Liver Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Crohn's Disease With Perianal Fistulas

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Keywords

  • Perianal fistulas
  • Crohn's disease
03

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's enrollment of 76 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Foundation for Liver Research is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    1

    Adalimumab

    Drug: adalimumab

  • Placebo comparator
    2

    ciprofloxacin

    Drug: ciprofloxacin

Interventions

  • Drugadalimumab

    24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks

    Also known as: Humira

  • Drugciprofloxacin

    12 weeks; daily 2 x 500mg

    Also known as: Cipro

06

What researchers measure

Primary outcomes

  1. Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.

    Time frame: 12 week

Secondary outcomes

  1. Proportion of patients in remission

    Time frame: 12 week

07

Study locations

13 sites
  • AMC
    Amsterdam, Netherlands
  • VU
    Amsterdam, Netherlands
  • Deventer ziekenhuis
    Deventer, Netherlands
  • Albert Schweitzer ziekenhuis
    Dordrecht, Netherlands
  • Medisch Spectrum Twente
    Enschede, Netherlands
  • UMC Gronigen
    Groningen, Netherlands
  • LUMC
    Leiden, Netherlands
  • AZ Maastricht
    Maastricht, Netherlands
  • St Antonius ziekenhuis
    Nieuwegein, Netherlands
  • UMC Radboud
    Nijmegen, Netherlands
  • Erasmus MC
    Rotterdam, Netherlands
  • Haga ziekenhuis
    The Hague, Netherlands
  • UMC Utrecht
    Utrecht, Netherlands
08

References and documents

Publications

  • Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9. doi: 10.1136/gutjnl-2013-304488. Epub 2013 Mar 23. PubMed 23525574 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Sep 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2008
First posted
Aug 18, 2008
Start
Sep 2008
Primary completionActual
Sep 2011
CompletionActual
Dec 2011
Last update
Apr 17, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00736983
Lead sponsor
Foundation for Liver Research
Responsible party
Sponsor
First posted
Aug 18, 2008
Start date
Sep 2008
Primary completion
Sep 2011
Completion
Dec 2011
Last update
Apr 17, 2012

Study contacts

C.J. van der Woude, MD PhD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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