Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's - Full Text View

Sponsored by:	Foundation for Liver Research
Information provided by:	Foundation for Liver Research
ClinicalTrials.gov Identifier:	NCT00736983

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 III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Fistulas

Drug Information available for: Adalimumab Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin

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 ]

Estimated Enrollment:	146
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator adalimumab	Drug: adalimumab 24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
2: Placebo Comparator ciprofloxacin	Drug: ciprofloxacin 12 weeks; daily 2 x 500mg

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

Contacts

Contact: Elke Verhey	*31.10.7035941	e.verhey@erasmusmc.nl
Contact: Janneke van der Woude, MD PhD	*31.10.7031693	c.vanderwoude@erasmusmc.nl

Locations

Netherlands
Erasmus MC	Recruiting
Rotterdam, Netherlands
Principal Investigator: CJ van der Woude, MD PhD
VU	Recruiting
Amsterdam, Netherlands
Contact: AA van Bodegraven, MD PhD
Principal Investigator: AA van Bodegraven, MD PhD
LUMC	Recruiting
Leiden, Netherlands
Contact: M Holsbergen
Principal Investigator: D Hommes, MD PhD
Haga ziekenhuis	Recruiting
Den Haag, Netherlands
Principal Investigator: H.M. Houben, MD PhD
AMC	Recruiting
Amsterdam, Netherlands
Principal Investigator: P. Stokkers, MD PhD

Sponsors and Collaborators

Foundation for Liver Research

Investigators

Principal Investigator:

C.J. van der Woude, MD PhD

Erasmus MC

More Information

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

Keywords provided by Foundation for Liver Research:

Perianal fistulas
Crohn's disease

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Rectal Diseases
Fistula

Ciprofloxacin
Rectal Fistula
Digestive System Diseases
Intestinal Fistula
Crohn Disease
Gastroenteritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Digestive System Fistula

Enzyme Inhibitors
Antirheumatic Agents
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009