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

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Fistulas

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Adalimumab

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 ]

Estimated Enrollment:	146
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	November 2010 (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
Contact: Elke Verhey e.verhey@erasmusmc.nl
Principal Investigator: CJ van der Woude, MD PhD
VU	Recruiting
Amsterdam, Netherlands
Contact: AA van Bodegraven, MD PhD v.bodegraven@vumc.nl
Principal Investigator: AA van Bodegraven, MD PhD
LUMC	Recruiting
Leiden, Netherlands
Contact: M Holsbergen m.holsbergen@lumc.nl
Principal Investigator: D Hommes, MD PhD
Haga ziekenhuis	Recruiting
Den Haag, Netherlands
Contact: M Bijkerk m.bijkerk@hagaziekenhuis.nl
Principal Investigator: H.M. Houben, MD PhD
AMC	Recruiting
Amsterdam, Netherlands
Contact: P Stokkers, MD PhD p.stokkers@amc.nl
Principal Investigator: P. Stokkers, MD PhD
UMC Utrecht	Recruiting
Utrecht, Netherlands
Contact: Bas Oldenburg, MD PhD boldenbu@umcutrecht.nl
Principal Investigator: B Oldenburg, MD PhD
St Antonius ziekenhuis	Recruiting
Nieuwegein, Netherlands
Principal Investigator: J Tenthof van Noorden, MD PhD
Albert Schweitzer ziekenhuis	Recruiting
Dordrecht, Netherlands
Contact: Ruud Beukers, MD PhD r.beukers@asz.nl
Principal Investigator: R Beukers, MD PhD
Medisch Spectrum Twente	Not yet recruiting
Enschede, Netherlands
Contact: M GV Russel, MD PhD m.russel@ziekenhuis-mst.nl
Principal Investigator: M GV Russel, MD PhD
Reinier de Graaf Gasthuis	Active, not recruiting
Delft, Netherlands
Ikazia ziekenhuis	Active, not recruiting
Rotterdam, Netherlands
AZ Maastricht	Recruiting
Maastricht, Netherlands
Contact: Mia Cilissen mia.cilissen@mumc.nl
Principal Investigator: M Pierik, MD PhD
UMC Radboud	Active, not recruiting
Nijmegen, Netherlands
Deventer ziekenhuis	Active, not recruiting
Deventer, Netherlands
Slingeland ziekenhuis	Not yet recruiting
Doetinchem, Netherlands
Contact: P C van de Meeberg, MD PhD p.van.de.meeberg@slingeland.nl
Principal Investigator: P C van de Meeberg, MD PhD
Ziekenhuis Gelderse Vallei	Not yet recruiting
Ede, Netherlands
Contact: L Homans HomansL@zgv.nl
Principal Investigator: B JM Witteman, MD PhD
UMC Gronigen	Recruiting
Groningen, Netherlands
Contact: Jaquelien Mooibroek j.h.mooibroek@int.umcg.nl
Principal Investigator: H van Dullemen, MD PhD

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 ( Elke Verhey )
Study ID Numbers:	IBD 08-01, EudraCT#: 2007-005832-10
Study First Received:	August 15, 2008
Last Updated:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00736983 History of Changes
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:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Enzyme Inhibitors
Adalimumab
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Fistula
Ciprofloxacin
Rectal Fistula
Digestive System Diseases
Therapeutic Uses
Intestinal Fistula
Crohn Disease
Digestive System Fistula
Antirheumatic Agents
Gastroenteritis
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010