Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis
Phase 1
- Conditions
- lcerative colitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-003987-37-SI
- Lead Sponsor
- niversity Medical Centre Ljubljana, Department of gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1) Histologicaly confirmed ulcerative colitis
2) age <18 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
1) History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.
2) Active tuberculosis or other opportunistic bacterial, viral and fungal infections.
3) History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure .
4) Pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method