Colitis, Ulcerative
Conditions
Keywords
Golimumab, Inflammatory Bowel Disease, Optimization, Drug levels, Anti-drug antibody levels
Brief 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.
Interventions
DRUGGolimumab 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.
DRUGGolimumab treatment optimization.
Golimumab dosing will be optimized in patients without clinical response at week 6.
Sponsors
General University Hospital of Valencia
Hospital Clínico Universitario de Valencia
Hospital de Sagunto
Hospital Universitario La Fe
Hospital General Universitario de Alicante
Hospital Universitario Doctor Peset
Hospital Arnau de Vilanova
Hospital Provincial de Castellon
Merck Sharp & Dohme LLC
Hospital de Manises
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between serum Golimumab levels and clinical response. | Week 6. | 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. |
| Correlation between anti-Golimumab antibody levels and clinical response. | Week 6. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment optimization outcome. | Week 14 | 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. |
| Correlation between mucosal healing and serum Golimumab levels. | Week 54 | An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured. |
| Identification of cut-off values of serum golimumab concentration | Week 6 | Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice. |
| Correlation between mucosal healing and anti-Golimumab antibody levels. | Week 54 | An endoscopy will be performed at the end of the treatment and anti-Golimumab antibody levels will be measured. |
Countries
Spain
Contacts
Primary ContactJoaquín Hinojosa del Val, MD
Backup ContactVanesa Carretero López
Outcome results
None listed