NCT00736983

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Crohn's Disease With Perianal Fistulas

Interventions

Type	Name	Description
DRUG	adalimumab	24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
DRUG	ciprofloxacin	12 weeks; daily 2 x 500mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2008-08-18
• Last updated: 2012-04-17

Locations

13 sites across 1 country: Netherlands