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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736983
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Crohn's Disease With Perianal Fistulas Drug: adalimumab Drug: ciprofloxacin Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Study Start Date : September 2008
Primary Completion Date : September 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: adalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
Other Name: Humira
Placebo Comparator: 2
Drug: ciprofloxacin
12 weeks; daily 2 x 500mg
Other Name: Cipro

Primary Outcome Measures :
  1. Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. [ Time Frame: 12 week ]

Secondary Outcome Measures :
  1. Proportion of patients in remission [ Time Frame: 12 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736983

Amsterdam, Netherlands
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
Leiden, Netherlands
AZ Maastricht
Maastricht, Netherlands
St Antonius ziekenhuis
Nieuwegein, Netherlands
UMC Radboud
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
Principal Investigator: C.J. van der Woude, MD PhD Erasmus MC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Foundation for Liver Research Identifier: NCT00736983     History of Changes
Other Study ID Numbers: IBD 08-01
EudraCT#: 2007-005832-10
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Foundation for Liver Research:
Perianal fistulas
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Rectal Fistula
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors