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

Verified by: Foundation for Liver Research, July 2011
First Received: August 15, 2008 | Last Updated: July 12, 2011 | Phase: Phase 3 | Start Date: September 2008
Overall Status: Active, not recruiting | Estimated Enrollment: 76
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To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2011

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation 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 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

Clinical Trial Investigator Information

Lead Investigator: Foundation for Liver Research Other

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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)

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00736983