Optimization of Golimumab Treatment in Ulcerative Colitis
Lead SponsorHospital de Manises
This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.
Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.
Golimumab dosing will be optimized in patients without clinical response at week 6.
In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
In patients without clinical response at week 6, golimumab treatment will be optimized.
Inclusion Criteria: Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria. Exclusion Criteria: Patients with Crohn's disease or colitis pending classification Patients with ileoanal pouch Patients with perianal fistulas related to the disease Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet. Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections. Patients with moderate or severe heart failure (NYHA grade III / IV)