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

NCT05430412 | Unknown DMC

• 1 other identifier: GUITAR
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 10

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 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

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• Primary objective:evaluate if Adacolumn® can sustain clinical response to IFX for 12 weeks of follow-up (V.11) or 40 weeks of follow-up (V18). Clinical response to IFX will be evaluated through PUCAI SCORE

  Description of PUCAI score as continuous variable at V.11 and at V.18 will be performed. Response to IFX will be clinically significant if PUCAI score continues maintained below 30 during the study (follow-up visits), so the nº and % of patients with a PUCAI score below 30 points in all visits between baseline to V.11 and baseline to V.18 will be described. Furthermore, comparison scores in both visits (baseline vs. V.11 and baseline vs. V.18) will be performed, by means of absolute and relative changes

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

• Primary objective: evaluate if Adacolumn® can sustain clinical response to IFX for 12 weeks of follow-up (V.11) or 40 weeks of follow-up (V18). Clinical response to IFX will be evaluated through IFX-LEVELS

  Description of IFX levels as continuous variable at V.11 and at V.18 will be performed. Response to IFX will be clinically significant if IFX levels \> 6 μg/mL during the study, so the nº and % of patients with a IFX level \> 6 μg/mL in all visits between baseline to V.11 and baseline to V.18 will be described. Furthermore, comparison between IFX levels in both visits will be performed, by means of absolute and relative changes

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

• Primary objective:evaluate if Adacolumn® can sustain clinical response to IFX for 12 weeks of follow-up (V.11) or 40 weeks of follow-up (V18). Clinical response to IFX will be evaluated through STEROIDS USE

  Description of the number and percentage of patients with a change in steroids treatment from baseline to V.11 and from baseline to V.18. Furthermore, comparison between visits will be performed.

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

Secondary Outcomes (8)

• To evaluate the IFX and ATI level variations in the treatment regimen during the study period. Quantification of IFX trough and ATI levels, and description of the IFX dose at baseline, 12 and 40 weeks of follow-up

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

• To measure the PUCAI score variation during the study period. Measurement of PUCAI score at baseline, 12 and 40 weeks of follow-up.

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

• To determine the percentage of patients maintaining steroid-free response during the study period at 12 and 40 weeks.

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

• To describe the number of flare-ups during the study period. Patients experiencing flares-ups during the study period.

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

• To measure faecal calprotectin level during the study period. Quantification of faecal calprotectin level at baseline, 12 and 40 weeks of follow-up. Faecal calprotectin is associated with clinical remission with levels higher than 150 μg/g.

  Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

Study Arms (1)

Adacolumn

EXPERIMENTAL

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.

Device: Adacolumn

Interventions

Adacolumn DEVICE

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).

Adacolumn

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adacyte Therapeutics SL: lead
• Adknoma Health Research: collaborator

Study Sites (10)

Hospital Coimbra

Coimbra, Portugal

RECRUITING

Hospital Santa Maria

Lisbon, Portugal

RECRUITING

Hospital Soa Joao

Porto, Portugal

RECRUITING

Hospital H. Sant Joan de Déu

Sant Joan Despí, Barcelona, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

RECRUITING

Hospital Materno-Infantil del H.U.R. de Málaga

Málaga, Spain

RECRUITING

Hospital U. Ntra Señora de Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

Complejo H. Regional Virgen Del Rocío

Seville, Spain

RECRUITING

Hospital Universitari I Politècnic La Fe

Valencia, Spain

RECRUITING

Related Publications (36)

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Related Links

• Adacyte Therapeutics Therapeutics. Adacolumn®. Instructions for use
• Adacyte Therapeutics
• European Commission. Ethical Considerations for Clinical Trials
• European Medicines Agency. Informed Consent for Paediatric Clinical Trials in Europe 2015

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Francisco Javier Martín de Carpi

  Hospital San Joan de Deu

  STUDY CHAIR

• Jorge Manuel Bastos Amil Dias

  CHU Sao Joao

  STUDY CHAIR

Central Study Contacts

Pablo Zapico

CONTACT

34 687 975 712; p.zapico@adacyte.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: June 24, 2022
• Study Start: January 11, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2023-07

Locations

PT (3); ES (7)