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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00736983
First received: August 15, 2008
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Crohn's Disease With Perianal Fistulas
 Drug: adalimumab
Drug: ciprofloxacin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients in remission [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Adalimumab
 Drug: adalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
Other Name: Humira
Placebo Comparator: 2
ciprofloxacin
 Drug: ciprofloxacin
12 weeks; daily 2 x 500mg
Other Name: Cipro

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736983

Locations
Netherlands
VU
Amsterdam, Netherlands
AMC
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, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
Investigators
Principal Investigator: C.J. van der Woude, MD PhD Erasmus MC
  More Information

No publications provided

Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00736983     History of Changes
Other Study ID Numbers: IBD 08-01, EudraCT#: 2007-005832-10
Study First Received: August 15, 2008
Last Updated: April 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Crohn Disease
Fistula
Rectal Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Rectal Diseases
Ciprofloxacin
Adalimumab
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013