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

NCT00736983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-04-17

No results posted yet for this study

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

Conditions

  • Crohn's Disease With Perianal Fistulas

Interventions

DRUG

adalimumab

24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks

DRUG

ciprofloxacin

12 weeks; daily 2 x 500mg

Sponsors & Collaborators

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • C.J. van der Woude, MD PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736983 on ClinicalTrials.gov