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

Foundation for Liver Research

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease With Perianal Fistulas

Treatments: Drug: ciprofloxacin; Drug: adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00736983

EudraCT#: 2007-005832-10

IBD 08-01

Details and patient eligibility

About

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 description

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

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Adalimumab

Treatment:

Drug: adalimumab

2

Placebo Comparator group

Description:

ciprofloxacin

Treatment:

Drug: ciprofloxacin