Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
- Sponsor
- Foundation for Liver Research
- Study ID
- NCT00736983
- Phase
- PHASE3
- Status
- Completed
Conditions
- Crohn's Disease With Perianal Fistulas
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- adalimumab — DRUG24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
- ciprofloxacin — DRUG12 weeks; daily 2 x 500mg
Study Details
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
Key Dates
- Start date
- Sep 30, 2008
- Status verified
- Apr 2012
- Primary completion
- Sep 30, 2011
- Completion
- Dec 31, 2011
Study Design
- Enrollment
- 76 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: 1Adalimumab
- Placebo Comparator: 2ciprofloxacin
Primary Outcome Measure
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. [ Time Frame: 12 week ]