Adalimumab for the treatment of perianal fistulas in Crohnâ¤*s disease more effective alone or combined to ciprofloxacin (ADAFI study)

Adalimumab for the treatment of perianal fistulas in Crohnâ¤*s disease more effective alone or combined to ciprofloxacin (ADAFI study) - ADAFI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35435

Enrollment

146

Registered

2007-12-27

Start date

2008-09-16

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal Fistulizing Crohns disease

Interventions

Medication, dosage and duration - Group A receive Adalimumab 160 mg at day 0, 80 mg at week 2, 40 mg at week 4 and every 14 days thereafter by subcutaneous injection combined with oral Ciprofloxacin

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Abscesses perianal lactation, pregnancy TBC or other infectious diseaseses expected surgery in 6 months

Design outcomes

Secondary

Measure	Time frame
Secondary outcomes: · Proportion of patients in remission · Safety and tolerability of adalimumab combined with ciprofloxacin · Quality of life and psychopathology by psychological assessment using the IBDQ questionnaire · Change of PDAI score	—

Primary

Measure	Time frame
Primary outcome (response): · Reduction of 50% or more from baseline to week 12 in the number of draining fistulas. Closure is defined as no drainage despite firm finger compression.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)