CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis

Launched by ADACYTE THERAPEUTICS SL · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a treatment called GMA to the medication Infliximab (IFX) can help children and teenagers with a condition called ulcerative colitis (UC) who haven’t responded well to steroids. The main goals are to see if this combination reduces the symptoms of UC, measured by a scoring system called the PUCAI, and if it helps maintain healthy levels of IFX in the blood. A significant improvement is considered when the PUCAI score stays below 30 during the study, and if patients no longer need steroids.

To be eligible for this trial, participants must be under 18 years old, weigh at least 25 kg, and have been diagnosed with ulcerative colitis that did not improve with steroids. They should have already started treatment with IFX and shown some improvement before joining the study. Participants will need to visit the study site regularly and have their progress monitored. It's important for the patient's legal guardian to give consent, and the patient must also agree to participate. This trial is currently recruiting, and anyone interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients under 18 years of age and weighing ≥25 kg at the time of study initiation.
• • 2. Patients with diagnosis of UC.
• • 3. Patients who started IFX treatment due to the lack of response to corticosteroids following an UC flare-up (steroid-refractory UC).
• • 4. Patients who have received IFX between 12 and 16 weeks prior to the study initiation.
• • 5. Patients who have showed a clinical response to IFX at the time of study initiation (defined as a reduction of at least 15 points in PUCAI score and being maintained below 30 points).
• • 6. Patients with therapeutic IFX blood levels (above 6 μg/mL) at the time of study initiation.
• • 7. Patient´s legal guardian must be willing and able to give written informed consent, and the patient must be willing to give written informed assent (if applicable as determined by the Ethics Committee) and comply with the Study visit Schedule.
• Exclusion Criteria:
• • 1. Patients who have received another anti-TNF prior to entry in the study.
• • 2. Patients with a peripheral circulation count of less than 2,000 granulocytes per μL.
• • 3. Pregnant and lactating of childbearing potential patients.
• • 4. Participation in another study or use of any experimental therapy within 30 days before day 1 of Study initiation.