The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease patients after 52 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
Metronidazole: 250 mg/8h. 3 months.
Metronidazole 250 mg/8h 3 months
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Bellvitge
Barcelona, Barcelona, Spain
Number of endoscopic recurrences
Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index.
Time frame: 52 weeks after the begin of the study
Number of Crohns´disease remission
% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azathioprin treatment
Time frame: 24 weeks
Number of postsurgical recurrences
Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography
Time frame: 52 week
number of hospitalized patients
Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment
Time frame: 52 weeks
Concentration of activity markers
Evaluating changes in markers such as reactive c-protein, variable surface glycoprotein , faecal calprotectin, etc.
Time frame: 24 weeks
Number of surgeries
Comparing % of patients who needs surgery on Adalimumab vs Azatioprine
Time frame: Until 52 week
SIBDQ and EuroQOL indexes
Quality of life
Time frame: 24 Weeks
Number of Adverse event reports
Comparison of safety of Adalimumab versus Azatioprine.
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Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Hospital Mutua de Terrasa
Terrassa, Barcelona, Spain
Hospital General Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Puerto Real
Puerto Real, Cádiz, Spain
Hospital Reina Sofía
Córdoba, Córdoba, Spain
Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain
Hospital de Fuenlabrada
Fuenlabrada, Madrid, Spain
...and 12 more locations
Time frame: 52 weeks
Number of Crohns´disease remission
% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment
Time frame: 52 weeks
Concentration of activity markers
Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc
Time frame: 52 weeks
SIBDQ and EuroQOL indexes
Quality of life
Time frame: 52 weeks