Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
NCT ID: NCT00736983
Last Updated: 2012-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2008-09-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Adalimumab
adalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
2
ciprofloxacin
ciprofloxacin
12 weeks; daily 2 x 500mg
Interventions
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adalimumab
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
ciprofloxacin
12 weeks; daily 2 x 500mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Single or multiple draining perianal fistulas
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Foundation for Liver Research
OTHER
Responsible Party
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Principal Investigators
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C.J. van der Woude, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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AMC
Amsterdam, , Netherlands
VU
Amsterdam, , 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
Haga ziekenhuis
The Hague, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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References
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Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9. doi: 10.1136/gutjnl-2013-304488. Epub 2013 Mar 23.
Other Identifiers
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EudraCT#: 2007-005832-10
Identifier Type: -
Identifier Source: secondary_id
IBD 08-01
Identifier Type: -
Identifier Source: org_study_id
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