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

Crohn's Disease With Perianal Fistulas Clinical Trial

— Adafi  

Official title:

Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736983
• Other study ID #: IBD 08-01
• Secondary ID: EudraCT#: 2007-0
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2008
• Last updated: April 16, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease With Perianal Fistulas
• Fistula
• Rectal Fistula

Intervention

Drug:
• adalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
• ciprofloxacin
12 weeks; daily 2 x 500mg

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam
Netherlands	VU	Amsterdam
Netherlands	Haga ziekenhuis	Den Haag
Netherlands	Deventer ziekenhuis	Deventer
Netherlands	Albert Schweitzer ziekenhuis	Dordrecht
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	UMC Gronigen	Groningen
Netherlands	LUMC	Leiden
Netherlands	AZ Maastricht	Maastricht
Netherlands	St Antonius ziekenhuis	Nieuwegein
Netherlands	UMC Radboud	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.		12 week	No
Secondary	Proportion of patients in remission		12 week	No