Metronidazole
DrugMetronidazole: 250 mg/8h. 3 months.
Other names: Flagyl (Metronidazole)
NCT Number: NCT01564823
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Metronidazole: 250 mg/8h. 3 months.
Other names: Flagyl (Metronidazole)
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
Other names: Imurel (Azathioprine)
Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
Other names: Humira (Adalimumab)
Time frame: 52 weeks after the begin of the study
Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index.
Time frame: 24 weeks
% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azathioprin treatment
Time frame: 52 week
Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography
Time frame: 52 weeks
Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment
Time frame: 24 weeks
Evaluating changes in markers such as reactive c-protein, variable surface glycoprotein , faecal calprotectin, etc.
Time frame: Until 52 week
Comparing % of patients who needs surgery on Adalimumab vs Azatioprine
Time frame: 24 Weeks
Quality of life
Time frame: 52 weeks
Comparison of safety of Adalimumab versus Azatioprine.
Time frame: 52 weeks
% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment
Time frame: 52 weeks
Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc
Time frame: 52 weeks
Quality of life
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Other
Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease
Acronym: APPRECIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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