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

Foundation for Liver Research76 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Crohn's Disease With Perianal Fistulas

Interventions

adalimumabDRUG

24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks

ciprofloxacinDRUG

12 weeks; daily 2 x 500mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (13)

AMC

Amsterdam, Netherlands

Deventer ziekenhuis

Deventer, Netherlands

Albert Schweitzer ziekenhuis

Outcomes

Primary Outcomes

Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.

Time frame: 12 week

Secondary Outcomes

Proportion of patients in remission

Time frame: 12 week

Data from ClinicalTrials.gov

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