Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease

Phase 3 Completed 86 enrolled Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Effice Servicios Para la Investigacion S.L. · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start: 2012-06
Primary completion: 2015-01
Completion: 2015-01

Outcome

Missed primary endpoint

paper therapy failed in 23/39 patients in the AZA group [59%] and 19/45 patients in the ADA group [42.2%] [p = 0.12]. PMID 28402454 ↗

paper CONCLUSIONS: ADA has not demonstrated a better efficacy than AZA [both associated with metronidazole] for prophylaxis of POR-CD PMID 28402454 ↗

Publications

Lopez-Sanroman A, Vera-Mendoza I, Domenech E, Taxonera C, Vega Ruiz V, Marin-Jimenez I, Guardiola J, Castro L, Esteve M, Iglesias E, Ceballos D, Martinez-Montiel P, Gisbert JP, Minguez M, Echarri A, Calvet X, Barrio J, Hinojosa J, Martin-Arranz MD, Marquez-Mosquera L, Bermejo F, Rimola J, Pons V, Nos P; Spanish GETECCU group [APPRECIA study]. Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial. J Crohns Colitis. 2017 Oct 27;11(11):1293-1301. doi: 10.1093/ecco-jcc/jjx051.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Azathioprine	Small molecule	2.5 mg/kg	Oral
Comparator	Metronidazole	Small molecule	250 mg	Oral