Adalimumab for the treatment of perianal fistulas in Crohnâ¤*s disease more effective alone or combined to ciprofloxacin (ADAFI study)
Phase 3
Completed
- Conditions
- 10018012Perianal Fistulizing Crohns disease
- Registration Number
- NL-OMON35435
- Lead Sponsor
- Stichting Leveronderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 146
Inclusion Criteria
Endoscopically or histologically proven Crohn*s disease before 3 months prior to randomization
Single or multiple draining perianal fistulas
Age 18-70 years
Written informed consent
Adequate contraception for males and females during treatment and follow up
Exclusion Criteria
Abscesses perianal
lactation, pregnancy
TBC or other infectious diseaseses
expected surgery in 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome (response):<br /><br>· Reduction of 50% or more from baseline to week 12 in the number of draining<br /><br>fistulas. Closure is defined as no drainage despite firm finger compression.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes:<br /><br>· Proportion of patients in remission<br /><br>· Safety and tolerability of adalimumab combined with ciprofloxacin<br /><br>· Quality of life and psychopathology by psychological assessment using the<br /><br>IBDQ questionnaire<br /><br>· Change of PDAI score</p><br>