National GMA Post-market Clinical Follow-up Study (GRACE)

Launched by ADACYTE THERAPEUTICS SL · Nov 24, 2022

Keywords

ClinConnect Summary

The GRACE study is looking at a treatment called granulocytapheresis (GMA) for people with inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis. This treatment helps reduce inflammation in the digestive tract by filtering out certain white blood cells that cause inflammation. The study aims to see how well GMA works in real-life situations for patients who are starting this treatment, especially those who may have trouble with standard medications, like corticosteroids.

To be eligible to participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of either Crohn's disease or ulcerative colitis. Your doctor must also decide that GMA is the right option for you, and you need to be able to understand and agree to participate in the study. If you join, you can expect to undergo this blood-filtering treatment and be monitored by healthcare professionals. It's essential to know that if you have any medical or psychological issues that could affect your ability to participate, or if you're already in another study, you might not be able to take part in this one.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥18 years.
• • 2. Established diagnosis of UC or CD according to ECCO criteria.
• • 3. Patients in whom the physician in charge of treatment decides to start treatment with GMA and independently of their inclusion in the study.
• • 4. Patients who understand and voluntarily sign informed consent.
• Exclusion Criteria:
• • 1. Patient with any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
• • 2. Patient who is participating in a clinical trial.
• • NOTE: If the physician knows or suspects that the patient is unable to understand the implications of his/her participation in the study, the patient should not enter without the signature of his/her legal representative

Trial Officials