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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736983
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):
Foundation for Liver Research

August 15, 2008
August 18, 2008
April 17, 2012
September 2008
September 2011   (Final data collection date for primary outcome measure)
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. [ Time Frame: 12 week ]
Same as current
Complete list of historical versions of study NCT00736983 on Archive Site
Proportion of patients in remission [ Time Frame: 12 week ]
Same as current
Not Provided
Not Provided
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
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
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Crohn's Disease With Perianal Fistulas
  • Drug: adalimumab
    24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
    Other Name: Humira
  • Drug: ciprofloxacin
    12 weeks; daily 2 x 500mg
    Other Name: Cipro
  • Active Comparator: 1
    Intervention: Drug: adalimumab
  • Placebo Comparator: 2
    Intervention: Drug: ciprofloxacin
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
IBD 08-01
EudraCT#: 2007-005832-10
Not Provided
Not Provided
Foundation for Liver Research
Foundation for Liver Research
Not Provided
Principal Investigator: C.J. van der Woude, MD PhD Erasmus MC
Foundation for Liver Research
April 2012

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