Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
Adafi
Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
2 other identifiers
interventional
76
1 country
13
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2008
Typical duration for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 17, 2012
April 1, 2012
3 years
August 15, 2008
April 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
12 week
Secondary Outcomes (1)
Proportion of patients in remission
12 week
Study Arms (2)
1
ACTIVE COMPARATORAdalimumab
2
PLACEBO COMPARATORciprofloxacin
Interventions
Eligibility Criteria
You may qualify if:
- proven Crohn's disease
- Single or multiple draining perianal fistulas
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Related Publications (1)
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.
PMID: 23525574DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C.J. van der Woude, MD PhD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2008
First Posted
August 18, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
April 17, 2012
Record last verified: 2012-04