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Randomized clinical trial to evaluate clinical response and quality of life in Crohn's Disease: Infliximab versus Adalimumab

Grant number: 15/02627-6
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): July 01, 2015
Effective date (End): November 30, 2016
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Ligia Yukie Sassaki
Grantee:Erika Mayumi Watanabe
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Crohn's disease (CD) is a chronic inflammatory bowel disease that leads to the appearance of ulcers, fistulas and estenosis affecting social relationships and quality of life. Biological therapy has revolutionized the treatment of CD and consists of anti-tumor necrosis factor (anti-TNF). In Brazil we have available Infliximab (IFX) and Adalimumab (ADA). The choice between the two agents is based on patient preference, convenience or medical indication. In the literature there are no prospective clinical trials comparing the efficacy of these medications. The aim of our study is to compare the efficacy of IFX versus ADA to clinical response and improvement of quality of life. 36 outpatients with biological therapy indications will be randomized betwen IFX or ADA and followed for 14 weeks. Patients will be evaluated at weeks 0 and 14 of treatment. In all evaluations will be collected data from clinical disease, quality of life and laboratory tests. To evaluate the clinical activity of the disease will use the Activity Index of Crohn's disease (CDAI). To assess the quality of life will be used the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ). The outcome variables will be the improvement of the disease characterized by a decrease in CDAI > 70 points and improved quality of life (IBDQ > 210 points) at week 14. Statistical analysis: descriptive, ANOVA with repeated measures considering the interaction drug x time, then set the Tukey multiple comparison test.