Crohn's Disease With Perianal Fistulas
Conditions
Keywords
Perianal fistulas, Crohn's disease
Brief 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.
Interventions
DRUGadalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
DRUGciprofloxacin
12 weeks; daily 2 x 500mg
Sponsors
Foundation for Liver Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. | 12 week |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients in remission | 12 week |
Countries
Netherlands
Outcome results
None listed