Clinical trial NCT03669029: Optimization of Golimumab Treatment in Ulcerative Colitis
Official title: Optimization of Golimumab Treatment in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colitis, Ulcerative
Keywords: Golimumab
Inflammatory Bowel Disease
Optimization
Drug levels
Anti-drug antibody levels
Lead sponsor: Hospital de Manises
Sponsor class: OTHER
Collaborators: name: General University Hospital of Valencia
name: Hospital Clínico Universitario de Valencia
name: Hospital de Sagunto
name: Hospital Universitario La Fe
name: Hospital General Universitario de Alicante
name: Hospital Universitario Doctor Peset
name: Hospital Arnau de Vilanova
name: Hospital Provincial de Castellon
name: Merck Sharp & Dohme LLC
First posted: 2018-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Correlation between serum Golimumab levels and clinical response.
timeFrame: Week 6.
measure: Correlation between anti-Golimumab antibody levels and clinical response.
timeFrame: Week 6.
Secondary outcomes:
measure: Treatment optimization outcome.
timeFrame: Week 14
measure: Correlation between mucosal healing and serum Golimumab levels.
timeFrame: Week 54
measure: Identification of cut-off values of serum golimumab concentration
timeFrame: Week 6
measure: Correlation between mucosal healing and anti-Golimumab antibody levels.
timeFrame: Week 54
Other outcomes:
Locations:
city: Manises
country: Spain
facility: Joaquín Hinojosa del Val
state: Valencia
Study officials:
affiliation: Hospital de Manises
name: Joaquín Hinojosa del Val, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fasanmade AA, Adedokun OJ, Ford J, Hernandez D, Johanns J, Hu C, Davis HM, Zhou H. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol. 2009 Dec;65(12):1211-28. doi: 10.1007/s00228-009-0718-4. Epub 2009 Sep 16.
citation: Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.
citation: Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14.
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citation: Berends S, Strik A, van Egmond P, Brandse H, Mathôt R,D'Haens G, Löwenberg M. Pharmacokinetics of golimumab in patients with moderate tosevere ulcerative colitis. J Crohn´s Colitis 2016; 10 (suppl 1):s424 AP637
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