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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Liver Research
• Treatments: Adalimumab; Ciprofloxacin

Criteria

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