Trial | NCT03669029  Report issue

Official Title

Optimization of Golimumab Treatment in Ulcerative Colitis

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
Study Started
Oct 01
2018
Anticipated
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Sep 13
2018

Drug Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg

Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.

Drug Golimumab treatment optimization.

Golimumab dosing will be optimized in patients without clinical response at week 6.

Week 6 Responders Experimental

In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.

Week 6 Non Responders Experimental

In patients without clinical response at week 6, golimumab treatment will be optimized.

Criteria 

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)
No Results Posted