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

Condition(s) targeted: Crohn's Disease With Perianal Fistulas

Intervention: adalimumab (Drug); ciprofloxacin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Foundation for Liver Research

Official(s) and/or principal investigator(s):
C.J. van der Woude, MD PhD, Principal Investigator, Affiliation: Erasmus MC

Overall contact:
Elke Verhey, Phone: *31.10.7035941, Email: e.verhey@erasmusmc.nl

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome: Proportion of patients in remission

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Elke Verhey, Phone: *31.10.7035941, Email: e.verhey@erasmusmc.nl

Erasmus MC, Rotterdam, Netherlands; Recruiting
Elke Verhey, Email: e.verhey@erasmusmc.nl
CJ van der Woude, MD PhD, Principal Investigator

VU, Amsterdam, Netherlands; Recruiting
AA van Bodegraven, MD PhD, Email: v.bodegraven@vumc.nl
AA van Bodegraven, MD PhD, Principal Investigator

LUMC, Leiden, Netherlands; Recruiting
M Holsbergen, Email: m.holsbergen@lumc.nl
D Hommes, MD PhD, Principal Investigator

Haga ziekenhuis, Den Haag, Netherlands; Recruiting
M Bijkerk, Email: m.bijkerk@hagaziekenhuis.nl
H.M. Houben, MD PhD, Principal Investigator

AMC, Amsterdam, Netherlands; Recruiting
P Stokkers, MD PhD, Email: p.stokkers@amc.nl
P. Stokkers, MD PhD, Principal Investigator

UMC Utrecht, Utrecht, Netherlands; Recruiting
Bas Oldenburg, MD PhD, Email: boldenbu@umcutrecht.nl
B Oldenburg, MD PhD, Principal Investigator

St Antonius ziekenhuis, Nieuwegein, Netherlands; Recruiting
J Tenthof van Noorden, MD PhD, Principal Investigator

Albert Schweitzer ziekenhuis, Dordrecht, Netherlands; Recruiting
Ruud Beukers, MD PhD, Email: r.beukers@asz.nl
R Beukers, MD PhD, Principal Investigator

UMC Gronigen, Groningen, Netherlands; Recruiting
Jaquelien Mooibroek, Email: j.h.mooibroek@int.umcg.nl
H van Dullemen, MD PhD, Principal Investigator

Reinier de Graaf Gasthuis, Delft, Netherlands; Active, not recruiting

Ikazia ziekenhuis, Rotterdam, Netherlands; Active, not recruiting

AZ Maastricht, Maastricht, Netherlands; Recruiting
Mia Cilissen, Email: mia.cilissen@mumc.nl
M Pierik, MD PhD, Principal Investigator

UMC Radboud, Nijmegen, Netherlands; Active, not recruiting

Deventer ziekenhuis, Deventer, Netherlands; Active, not recruiting

Slingeland ziekenhuis, Doetinchem, Netherlands; Not yet recruiting
P C van de Meeberg, MD PhD, Email: p.van.de.meeberg@slingeland.nl
P C van de Meeberg, MD PhD, Principal Investigator

Ziekenhuis Gelderse Vallei, Ede, Netherlands; Not yet recruiting
L Homans, Email: HomansL@zgv.nl
B JM Witteman, MD PhD, Principal Investigator

Medisch Spectrum Twente, Enschede, Netherlands; Not yet recruiting
M GV Russel, MD PhD, Email: m.russel@ziekenhuis-mst.nl
M GV Russel, MD PhD, Principal Investigator

Starting date: September 2008
Ending date: May 2011
Last updated: September 21, 2009