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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04156984 |
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Date of registration:
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24/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis
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Scientific title:
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Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens |
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Date of first enrolment:
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May 2020 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04156984 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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David Drobne, MD, PhD |
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Address:
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Telephone:
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+38615221552 |
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Email:
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david.drobne@kclj.si |
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Affiliation:
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Name:
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Borut Štabuc, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Name:
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David Drobne, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Golimumab Prefilled Syringe
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Primary Outcome(s)
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Endoscopic outcome
[Time Frame: 50 weeks]
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Secondary Outcome(s)
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Association of golimumab through levels and Anti-golimumab antibodies development on endoscopic and clinical outcome.
[Time Frame: 50 weeks]
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Clinical outcome
[Time Frame: 50 weeks]
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Secondary ID(s)
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2019-001G
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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