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

Overview

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

Full Title of Study: “Adalimumab for the Treatment of Perianal Fistulas in Crohn’s Disease More Effective Alone or Combined to Ciprofloxacin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2011

Detailed Description

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

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Proportion of patients in remission
    • Time Frame: 12 week

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Foundation for Liver Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • C.J. van der Woude, MD PhD, Principal Investigator, Erasmus Medical Center

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