Optimization of Golimumab Treatment in Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Optimization of Golimumab Treatment in Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
* Drug: Golimumab treatment optimization.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Week 6 Responders<br>In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response. | Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg<br>* Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.<br>|
| Experimental: Week 6 Non Responders<br>In patients without clinical response at week 6, golimumab treatment will be optimized. | Drug: Golimumab treatment optimization.<br>* Golimumab dosing will be optimized in patients without clinical response at week 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 54 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Golimumab, Inflammatory Bowel Disease, Optimization, Drug levels, Anti-drug antibody levels