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OpenTrials
Completed

NCT Number: NCT00736983

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

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

Completed

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Key information

Conditions

Crohn's Disease With Perianal Fistulas Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AMC, Amsterdam, Netherlands

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

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

Other names: Humira

Ciprofloxacin

Drug

12 weeks; daily 2 x 500mg

Other names: Cipro

Primary outcomes

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

    Time frame: 12 week

Secondary outcomes

  1. Proportion of patients in remission

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Foundation for Liver Research

Other

Registry information

Official study title

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

Acronym: Adafi

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2008
Registry last updated
Apr 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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