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EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB

IRCCS San Raffaele · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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inflammatory-bowel-diseases
Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. in patients with gastroenterological or rheumatological indication at month 12.Patients who are eligible but were switched before the inclusion in this study will also be enrolled, and the data already collected according to clinical practice and consistent with the study outcome measures will be used retrospectively. All patients will be followed up according to the standard of care of each participating center. The main questions it aims to answer are: 1. To investigate the effectiveness at month 2, 6 and 12 after switching to infliximab s.c. 2. To investigate the safety profile at month 2, 6 and 12 after switching to infliximab s.c. 3. To investigate the difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching. 4. To investigate the presence of baseline predictors for drug persistence at month 12 (sex, age, disease type, disease severity, body mass index, concomitant medications, smoking habit, presence of comorbidities). 5. To investigate whether there is any change between baseline and week 52 in the following aspects: * Job type and need for any authorization to go to the hospital to receive the study drug * Distance and duration of the travel home-hospital * Mode of travel home-hospital * Need for a caregiver to be present * Time spent at hospital * Patient's preference for the way of study drug administration expressed on a 10-grades VAS scale. The study period for observation will be 12 months from the date of switch. At week 0, month 2, 6 and 12 from the date of the switch, clinical activity, safety data and biomarker levels will be collected. For those patients who have ha
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