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Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

NCT04156984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-07-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Golimumab Prefilled Syringe

See arm description

Sponsors & Collaborators

  • David Drobne

    lead OTHER

Principal Investigators

  • David Drobne, MD, PhD · University Medical Centre Ljubljana

  • Borut Štabuc, MD, PhD · University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2024-06-18
Completion
2024-06-18
FDA Drug
Yes

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04156984 on ClinicalTrials.gov