Optimization of Golimumab Treatment in Ulcerative Colitis

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

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.

Sponsors & Collaborators

• General University Hospital of Valencia

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Hospital de Sagunto

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital General Universitario de Alicante

  collaborator OTHER

• Hospital Universitario Doctor Peset

  collaborator OTHER

• Hospital Arnau de Vilanova

  collaborator OTHER

• Hospital Provincial de Castellon

  collaborator OTHER

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Hospital de Manises

  lead OTHER

Principal Investigators

• Joaquín Hinojosa del Val, MD · Hospital de Manises

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Spain

Study Locations