A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients
- Conditions
- Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-002038-35-BE
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
• At least 18 years old at inclusion
• Established diagnosis of Crohn’s disease with clinical disease activity (Harvery-Bradshaw index (HBI) > 4) and endoscopic activity (Simple Endoscopic Score for Crohn’s disease (SES-CD)= 6 or SES-CD = 4 in patients with ileitis only)
• Adequate contraception in female of reproductive age (oral contraception, intra uterine device, sterilisation or barrier method)
• Participants must sign an informed consent form indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
• Patients who previously received ustekinumab or an anti-IL23 antibody
• Patients with ostomies
• Women that are pregnant, nursing, or planning 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