A clinical trial to assess whether guselkumab and golimumab when used together is safe and effective for treating participants with moderately to severely active ulcerative colitis (UC).
About this study
Guselkumab has been approved in the USA, the European Union (EU), Canada, and several other countries, including the Australian health authority (Therapeutic Goods Administration), for the treatment of adult patients with moderate to severe plaque psoriasis. In addition, guselkumab is being studied for the treatment of psoriatic arthritis, Crohn’s disease, and paediatric psoriasis.
Golimumab has been approved in countries worldwide, including by the Therapeutic Goods Administration, for the indications of moderately to severely active UC, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Anticipated enrolment close date: December 2020
Who can take part
Inclusion criteria
- 18 to 65 years of age
- Clinical diagnosis of UC
Exclusion criteria
- Presence of stoma
- Presence of history of fistula
What's involved
- Medical history
- Physical exam
- Electrocardiogram (ECG)
- Weight
- Height
- Blood pressure
- Pulse
- Heart rate
- Health questionnaires
- Blood samples
- Urine test
- Colonoscopy with biopsy collection
- Stool tests
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.