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

Primary Purpose

Crohn's Disease With Perianal Fistulas

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
adalimumab
ciprofloxacin
Sponsored by
Foundation for Liver Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease With Perianal Fistulas focused on measuring Perianal fistulas, Crohn's disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AMC
  • VU
  • Haga ziekenhuis
  • Deventer ziekenhuis
  • Albert Schweitzer ziekenhuis
  • Medisch Spectrum Twente
  • UMC Gronigen
  • LUMC
  • AZ Maastricht
  • St Antonius ziekenhuis
  • UMC Radboud
  • Erasmus MC
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Adalimumab

ciprofloxacin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients in remission

Full Information

First Posted
August 15, 2008
Last Updated
April 16, 2012
Sponsor
Foundation for Liver Research
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1. Study Identification

Unique Protocol Identification Number
NCT00736983
Brief Title
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
Acronym
Adafi
Official Title
Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Liver Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease With Perianal Fistulas
Keywords
Perianal fistulas, Crohn's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Adalimumab
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira
Intervention Description
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin
Other Intervention Name(s)
Cipro
Intervention Description
12 weeks; daily 2 x 500mg
Primary Outcome Measure Information:
Title
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Proportion of patients in remission
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.J. van der Woude, MD PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
VU
City
Amsterdam
Country
Netherlands
Facility Name
Haga ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Deventer ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Albert Schweitzer ziekenhuis
City
Dordrecht
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
UMC Gronigen
City
Groningen
Country
Netherlands
Facility Name
LUMC
City
Leiden
Country
Netherlands
Facility Name
AZ Maastricht
City
Maastricht
Country
Netherlands
Facility Name
St Antonius ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
UMC Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23525574
Citation
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.
Results Reference
derived

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

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