Status:
UNKNOWN
CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
Lead Sponsor:
Adacyte Therapeutics SL
Collaborating Sponsors:
Adknoma Health Research
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical response to IFX will be evaluated through the PUCAI score. The respons...
Detailed Description
The trial has the following objectives: Primary objective (PO): The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical resp...
Eligibility Criteria
Inclusion
- Patients under 18 years of age and weighing ≥25 kg at the time of study initiation.
- Patients with diagnosis of UC.
- Patients who started IFX treatment due to the lack of response to corticosteroids following an UC flare-up (steroid-refractory UC).
- Patients who have received IFX between 12 and 16 weeks prior to the study initiation.
- 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).
- Patients with therapeutic IFX blood levels (above 6 μg/mL) at the time of study initiation.
- 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
- Patients who have received another anti-TNF prior to entry in the study.
- Patients with a peripheral circulation count of less than 2,000 granulocytes per μL.
- Pregnant and lactating of childbearing potential patients.
- Participation in another study or use of any experimental therapy within 30 days before day 1 of Study initiation.
Key Trial Info
Start Date :
January 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05430412
Start Date
January 11 2022
End Date
October 1 2024
Last Update
January 17 2024
Active Locations (10)
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1
Hospital Coimbra
Coimbra, Portugal
2
Hospital Santa Maria
Lisbon, Portugal
3
Hospital Soa Joao
Porto, Portugal
4
Hospital H. Sant Joan de Déu
Sant Joan Despí, Barcelona, Spain