Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04156984
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

David Drobne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Drobne, MD, PhDBorut Štabuc, MD, PhD
Principal Investigator Affiliation University Medical Centre LjubljanaUniversity Medical Centre Ljubljana
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Slovenia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Other: Study arm

Subjects treated with optimized dose of golimumab, irrespective of weight: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4 weeks. In case of disease flare: discontinuation of drug.

Other: Control arm

Subjects treated according to current European Label (2019) based on body weight: <80kg: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 50 mg sc q4wk. In case of disease flare (defined as PRO-2 ≥1): dose optimization to 100 mg sc q4wk starting at week 6 or at any time during first year. ≥80kg: golimumab 200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4wk. In case of disease flare (defined as PRO-2 ≥1): discontinuation of drug.

Interventions

Drug: - Golimumab Prefilled Syringe

See arm description

Contact a Trial Team

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International Sites

Celje, Slovenia

Status

Address

General hospital Celje, Department of Gastoenterology

Celje, , 3000

Site Contact

Renata Šibli, MD,

renata.sibli@guest.arnes.si

+38634233441

Izola, Slovenia

Status

Address

General hospital Izola, Department of Internal medicine

Izola, , 6310

Site Contact

Tamara Marušič, MD

tamara.marusic@sb-izola.si

+38656606551

Ljubljana, Slovenia

Status

Address

University Medical Centre Ljubljana, Department of Gastroenterology

Ljubljana, , 1000

Site Contact

David Drobne, MD, PhD

david.drobne@kclj.si

+38615221552

Maribor, Slovenia

Status

Address

University Medical Centre Maribor, Department of Gastoenterology

Maribor, , 2000

Site Contact

Andreja Ocepek, MD

andreja.ocepek@ukc-mb.si

+38623212348

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