Optimization of Golimumab Treatment in Ulcerative Colitis

Sponsor
Hospital de Manises
Study ID
NCT03669029
Phase
PHASE4
Status
Unknown

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 1, 2018
Status verified
Sep 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Week 6 Responders
    In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
  • Experimental: Week 6 Non Responders
    In patients without clinical response at week 6, golimumab treatment will be optimized.

Primary Outcome Measure

Correlation between serum Golimumab levels and clinical response. [ Time Frame: Week 6. ]

Central Contacts

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