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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00736983
First received: August 15, 2008
Last updated: April 16, 2012
Last verified: April 2012

August 15, 2008
April 16, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00736983 on ClinicalTrials.gov Archive Site
Proportion of patients in remission [ Time Frame: 12 week ] [ Designated as safety issue: No ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
    Adalimumab
    Intervention: Drug: adalimumab
  • Placebo Comparator: 2
    ciprofloxacin
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00736983
IBD 08-01, EudraCT#: 2007-005832-10
No
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