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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.