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

Phase 3

Completed

• Conditions: Crohn's Disease With Perianal Fistulas
• Interventions: Drug: adalimumab; Drug: ciprofloxacin

• Registration Number: NCT00736983
• Lead Sponsor: Foundation for Liver Research

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.

Study Timeline

• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Study Start: 2008-09
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• proven Crohn's disease
• Single or multiple draining perianal fistulas

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	adalimumab	Adalimumab
2	ciprofloxacin	ciprofloxacin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in remission	12 week

Trial Locations

Locations (13)

LUMC; 🇳🇱 Leiden, Netherlands

St Antonius ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

UMC Radboud; 🇳🇱 Nijmegen, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Haga ziekenhuis; 🇳🇱 Den Haag, Netherlands

AMC; 🇳🇱 Amsterdam, Netherlands

UMC Gronigen; 🇳🇱 Groningen, Netherlands

VU; 🇳🇱 Amsterdam, Netherlands

Deventer ziekenhuis; 🇳🇱 Deventer, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

AZ Maastricht; 🇳🇱 Maastricht, Netherlands

Albert Schweitzer ziekenhuis; 🇳🇱 Dordrecht, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands