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Randomized clinical trial for evaluation of clinical remission and quality of life in patients with Ulcerative Colitis: Adalimumab versus Infliximab

Grant number: 16/01627-5
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): August 01, 2016
Effective date (End): July 31, 2018
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Ligia Yukie Sassaki
Grantee:Gabriela Cabral Bissoli
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Ulcerative Colitis (UC) is a chronic inflammatory disease that occur with diarrhea, abdominal pain, fatigue and weight loss, as well as extra intestinal manifestations, which can jeopardize social relationships and quality of life of their patients. Biological therapy has revolutionized the treatment of ulcerative colitis and consists of anti-tumor necrosis factor (anti-TNF). In Brazil, we have available the Infliximab (IFX) and Adalimumab (ADA). The choice between the two agents is based on the patient's preference, convenience of implementation or medical indication. In the literature there are no prospective clinical trials comparing the efficacy of these medications. We intend this study to compare the efficacy of IFX versus ADA for clinical response and improved quality of life for patients. An open clinical trial in which 36 patients with UC will be randomized and followed for 14 weeks will be held. Patients will be selected at the HC of the Botucatu School of Medicine with an indication of Biological Therapy. Patients will be evaluated at weeks 0 and 14 of treatment. In all tests, data will be collected from the disease and assessment of quality of life. To evaluate the clinical activity of the disease will be used the Mayo Score. To assess 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 the Mayo Scored2 points and improved quality of life (IBDQ> 210 points) at week 14. Statistical analysis: descriptive statistics, ANOVA with repeated measures over time considering the interaction medicine x time, then set the Tukey multiple comparison test. (AU)