Optimization of Golimumab Treatment in Ulcerative Colitis

Phase 4

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg; Drug: Golimumab treatment optimization.

• Registration Number: NCT03669029
• Lead Sponsor: Hospital de Manises

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-04
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-13
• Study Start: 2018-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Week 6 Responders	Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg	In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
Week 6 Non Responders	Golimumab treatment optimization.	In patients without clinical response at week 6, golimumab treatment will be optimized.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Joaquín Hinojosa del Val; 🇪🇸 Manises, Valencia, Spain