NCT03669029

Optimization of Golimumab Treatment in Ulcerative Colitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hospital de Manises · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-09-13
• Last updated: 2018-09-13

Locations

1 site across 1 country: Spain