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

NCT05430412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-01-17

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Adknoma Health Research

    collaborator INDUSTRY

  • Adacyte Therapeutics SL

    lead INDUSTRY

Principal Investigators

  • Francisco Javier Martín de Carpi · Hospital San Joan de Deu

  • Jorge Manuel Bastos Amil Dias · CHU Sao Joao

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430412 on ClinicalTrials.gov