NCT05430412

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Adacyte Therapeutics SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 response will be considered clinically significant if PUCAI points continue maintained below 30 during the study period. The IFX response will also be determined by IFX serum levels. A therapeutic IFX level, i.e. for achieving an adequate clinical response, is established above 6 μg/mL. Finally, the necessity, or not, of a steroid treatment during the study period will also be indicative of successful efficacy with GMA.

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 response to IFX will be evaluated through the PUCAI score. The response will be considered clinically significant if PUCAI points continue maintained below 30 during the study period. The IFX response will also be determined by IFX serum levels. A therapeutic IFX level, i.e. for achieving an adequate clinical response, is established above 6 μg/mL. Finally, the necessity, or not, of a steroid treatment during the study period will also be indicative of successful efficacy with GMA. Secondary objectives (SO): 1. Quantification of IFX trough and ATI levels, and description of the IFX dose at baseline, 12 and 40 weeks of follow-up. 2. Measurement of PUCAI score at baseline, 12 and 40 weeks of follow-up. 3. Patients maintaining clinical response off steroids, 12 and 40 weeks of follow-up. 4. Patients experiencing flares-ups during the study period. 5. Quantification of fecal calprotectin level at baseline, 12 and 40 weeks of follow-up. Fecal calprotectin is associated with clinical remission with levels higher than 150 μg/g. 6. Measurement of C-reactive protein, erythrocyte sedimentation rate, hemoglobin, albumin, platelet levels at baseline, 12 and 40weeks of follow-up. 7. Quantification of leucocyte counts in peripheral blood at baseline, 12 and 40 weeks of followup. 8. Monitoring of AEs during the study period

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Adacolumn	The study will consist of 10 sessions of Adacolumn® treatment (once per week) and a follow-up period (from week 12 to week 40 since study inclusion).

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-06-24
• Last updated: 2024-01-17

Locations

10 sites across 2 countries: Portugal, Spain