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Investigating the safety, feasibility, and optimal dose of Adalimumab-680LT in IBD – GUIDE study
EU CTIS ID: 2023-508391-11-00
What this study is testing
To evaluate the safety of adalimumab-680LT through monitoring vital signs, the injection site and evaluating possible tracer-related (severe) adverse events (SAE/AEs) and suspected unexpected serious adverse reactions (SUSARs). To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect adalimumab-680LT signals and to determine their most optimal imaging dose.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.