Investigating the safety, feasibility, and optimal dose of Adalimumab-680LT in IBD – GUIDE study
- Conditions
- Inflammatory Bowel Disease (IBD)Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-508391-11-00
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
Established IBD diagnosis (UC or CD), Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices and biochemically active disease as defined by a fecal calprotectin > 60 µg/g (measurement within the last 6 weeks before inclusion, Patients must be eligible for adalimumab therapy, Age of 18 years, Written informed consent., Clinical indication for an endoscopic procedure
A female study patient who is pregnant or provides breastfeeding will be excluded from participation in this study, Medical or psychiatric conditions that compromise the patient’s ability to give informed consent, Prior anti-TNF therapy in the last 6 weeks before inclusion, A female study patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT administration and the following 10 weeks, Active extra gastrointestinal manifestations of Crohn’s disease (e.g. uveitis or pyoderma gangrenosum at vital locations), Previous treatment with adalimumab and detectable anti-adalimumab antibodies levels
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