Optimization of Golimumab Treatment in Ulcerative Colitis

Hospital de Manises50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colitis, Ulcerative

Interventions

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

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

Golimumab treatment optimization.DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Joaquín Hinojosa del Val

Manises, Valencia, Spain

Outcomes

Primary Outcomes

Correlation between serum Golimumab levels and clinical response.

Serum Golimumab levels will be measured and clinical activity evaluation will be assessed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin.

Time frame: Week 6.

Correlation between anti-Golimumab antibody levels and clinical response.

Anti-golimumab antibody levels will be measure and clinical activity evaluation will be performed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin.

Time frame: Week 6.

Secondary Outcomes

Treatment optimization outcome.

Analyze the percentage of non-responder patients or patients with partial response at week 6 who achieve response/remission at week 14 after treatment optimization.

Time frame: Week 14

Correlation between mucosal healing and serum Golimumab levels.

An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured.

Time frame: Week 54

Identification of cut-off values of serum golimumab concentration

Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice.

Time frame: Week 6

Correlation between mucosal healing and anti-Golimumab antibody levels.

An endoscopy will be performed at the end of the treatment and anti-Golimumab antibody levels will be measured.

Time frame: Week 54

Central Contacts

Joaquín Hinojosa del Val, MD

CONTACT

+34 651184296 jhinojosad@gmail.com

Vanesa Carretero López

CONTACT

+34 96 184 50 65 vcarretero@hospitalmanises.es

Data from ClinicalTrials.gov

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