Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2009

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

Intervention(s) in this Clinical Trial

• Drug: adalimumab
  • 24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
• Drug: ciprofloxacin
  • 12 weeks; daily 2 x 500mg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • adalimumab
• Placebo Comparator: 2
  • ciprofloxacin

Primary Measures

• Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
  • Time Frame: 12 week
    Safety Issue?: No

Secondary Measures

• Proportion of patients in remission
  • Time Frame: 12 week
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Foundation for Liver Research

Overall Clinical Trial Officials and Contacts

C.J. van der Woude, MD PhD Principal Investigator Erasmus MC  

Overall Contact: Elke Verhey *31.10.7035941 e.verhey@erasmusmc.nl

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00736983

Study ID Number: IBD 08-01

ClinicalTrials.gov Identifier: NCT00736983

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)