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

Ulcerative Colitis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT05430412
• Study type: Interventional
• Source: Adacyte Therapeutics SL
• Contact: Pablo Zapico
• Phone: 34 687 975 712
• Email: p.zapico@adacyte.com
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Completion date: October 2024