CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Hospital Coimbra
- Hospital Santa Maria
- Hospital Soa Joao
- Hospital H. Sant Joan de DéuRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Infantil Universitario Niño JesúsRecruiting
- Hospital Materno-Infantil del H.U.R. de MálagaRecruiting
- Complejo H. Regional Virgen Del RocíoRecruiting
- Hospital U. Ntra Señora de CandelariaRecruiting
- Hospital Universitari I Politècnic La FeRecruiting
Arms of the Study
Arm 1
Experimental
Adacolumn
Adacolumn is a non-pharmacological treatment which reduces the inflammation by removing specifically targeted white blood cells from the blood circulation. The Adacolumn is designed to be used in combination with the Adamonitor and its Adastand, and the Adacircuit. The column has a capacity of 335 mL and is filled with cellulose acetate beads of 2 mm in diameter as the column adsorptive leukocytapheresis carriers. The carriers are bathed in 130 mL of sterile saline until use when the column is primed with additional sterile saline and then with heparinized saline prior to use. Patients will receive 10 sessions with Adacolumn. It would be reduced between 5 - 10, according to the patient´s response and following PI valuation. Patients will receive Adacolumn with IFX for that period of time. Patients will have received previously IFX for 12-16 weeks. visits will be conducted every week, for the application of Adacolumn.