Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04156984
• Other study ID #: 2019-001G
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2020
• Est. completion date: November 2022

Study information

• Verified date: March 2020
• Source: University Medical Centre Ljubljana
• Contact: David Drobne, MD, PhD
• Phone: +38615221552
• Email: david.drobne[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with <80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

Description:

Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with <80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed ulcerative colitis

Exclusion Criteria:

• Active tuberculosis or other opportunistic bacterial, viral and fungal infections

• History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure

• Pregnancy

• History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Golimumab Prefilled Syringe
See arm description

Locations

Country	Name	City	State
Slovenia	General hospital Celje, Department of Gastoenterology	Celje
Slovenia	General hospital Izola, Department of Internal medicine	Izola
Slovenia	University Medical Centre Ljubljana, Department of Gastroenterology	Ljubljana
Slovenia	University Medical Centre Maribor, Department of Gastoenterology	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
David Drobne

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of physical, social, and emotional status with The Short Inflammatory Bowel Disease Questionnaire.	The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (score 10-70, poor to good HRQoL). The questionnaire will be answered at week 0, week 6, week 14, week 26, week 38, week 50.	50 weeks
Other	Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0.	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.	50 weeks.
Primary	Endoscopic outcome	Number of participants with mucosal healing at week 14 and week 50 on flexible rectosigmoidoscopy (recorded and assessed centrally by blinded reader if possible). Mucosal healing is defined as Mayo endoscopic score 0 or 1.	50 weeks
Secondary	Clinical outcome	Number of participants in clinical remission at week 14, week 26, week 38 and week 50. Clinical remission is defined as PRO-2 (Patient-Reported Outcome) score 0 (no rectal bleeding and no diarrhea/altered bowel habit).	50 weeks
Secondary	Association of golimumab through levels and Anti-golimumab antibodies development on endoscopic and clinical outcome.	Measurement of golimumab through levels. Blood withdrawals will be preformed at prespecified time points in all patients: week 0, week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50.; Measurement of Anti-golimumab antibodies development. Blood withdrawals will be preformed at prespecified time points in all patients: week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50.	50 weeks