CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
NCT ID: NCT05430412
Last Updated: 2024-01-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
15 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-01-11
Study Completion Date
2024-10-31
Brief Summary
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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 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.
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Detailed Description
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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
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
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Ulcerative Colitis
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Adacolumn
Intervention Type
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).
Interventions
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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).
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Patients under 18 years of age and weighing ≥25 kg at the time of study initiation.
2. Patients with diagnosis of UC.
3. Patients who started IFX treatment due to the lack of response to corticosteroids following an UC flare-up (steroid-refractory UC).
4. Patients who have received IFX between 12 and 16 weeks prior to the study initiation.
5. 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).
6. Patients with therapeutic IFX blood levels (above 6 μg/mL) at the time of study initiation.
7. 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.
2. Patients with diagnosis of UC.
3. Patients who started IFX treatment due to the lack of response to corticosteroids following an UC flare-up (steroid-refractory UC).
4. Patients who have received IFX between 12 and 16 weeks prior to the study initiation.
5. 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).
6. Patients with therapeutic IFX blood levels (above 6 μg/mL) at the time of study initiation.
7. 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
1. Patients who have received another anti-TNF prior to entry in the study.
2. Patients with a peripheral circulation count of less than 2,000 granulocytes per μL.
3. Pregnant and lactating of childbearing potential patients.
4. Participation in another study or use of any experimental therapy within 30 days before day 1 of Study initiation.
2. Patients with a peripheral circulation count of less than 2,000 granulocytes per μL.
3. Pregnant and lactating of childbearing potential patients.
4. Participation in another study or use of any experimental therapy within 30 days before day 1 of Study initiation.
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Adknoma Health Research
INDUSTRY
Sponsor Role
collaborator
Adacyte Therapeutics SL
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Francisco Javier Martín de Carpi
Role: STUDY_CHAIR
Hospital San Joan de Deu
Jorge Manuel Bastos Amil Dias
Role: STUDY_CHAIR
CHU Sao Joao
Locations
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Hospital Coimbra
Coimbra, , Portugal
Site Status
RECRUITING
Hospital Santa Maria
Lisbon, , Portugal
Site Status
RECRUITING
Hospital Soa Joao
Porto, , Portugal
Site Status
RECRUITING
Hospital H. Sant Joan de Déu
Sant Joan Despí, Barcelona, Spain
Site Status
RECRUITING
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Site Status
RECRUITING
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Site Status
RECRUITING
Hospital Materno-Infantil del H.U.R. de Málaga
Málaga, , Spain
Site Status
RECRUITING
Hospital U. Ntra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Site Status
RECRUITING
Complejo H. Regional Virgen Del Rocío
Seville, , Spain
Site Status
RECRUITING
Hospital Universitari I Politècnic La Fe
Valencia, , Spain
Site Status
RECRUITING
Countries
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Portugal
Spain
Central Contacts
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Facility Contacts
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Ricardo Ferreira
Role: primary
Ana Isabel Lopes
Role: primary
Eunice Trindade
Role: primary
Francisco Javier Martin Carpi
Role: primary
Oscar Segarra
Role: primary
Laura María Palomino Pérez
Role: primary
Víctor Manuel Navas López
Role: primary
José Ramón Alberto Alonso
Role: primary
Alejandro Rodriguez
Role: primary
Ester Donat
Role: primary
References
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Measurement of infliximab and anti-infliximab antibody levels can help distinguish maintenance versus loss of response. Gastroenterol Hepatol (N Y). 2012 Feb;8(2):131-4. No abstract available.
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BACKGROUND
Turner D, Ruemmele FM, Orlanski-Meyer E, Griffiths AM, de Carpi JM, Bronsky J, Veres G, Aloi M, Strisciuglio C, Braegger CP, Assa A, Romano C, Hussey S, Stanton M, Pakarinen M, de Ridder L, Katsanos K, Croft N, Navas-Lopez V, Wilson DC, Lawrence S, Russell RK. Management of Paediatric Ulcerative Colitis, Part 1: Ambulatory Care-An Evidence-based Guideline From European Crohn's and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Aug;67(2):257-291. doi: 10.1097/MPG.0000000000002035.
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Zhu M, Xu X, Nie F, Tong J, Xiao S, Ran Z. The efficacy and safety of selective leukocytapheresis in the treatment of ulcerative colitis: a meta-analysis. Int J Colorectal Dis. 2011 Aug;26(8):999-1007. doi: 10.1007/s00384-011-1193-9. Epub 2011 Apr 8.
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Related Links
Access external resources that provide additional context or updates about the study.
https://www.adacyte.com/professional/products/adacolumn/
Adacyte Therapeutics Therapeutics. Adacolumn®. Instructions for use
https://www.adacyte.com
Adacyte Therapeutics
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/ethical_considerations_en.pdf
European Commission. Ethical Considerations for Clinical Trials
https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf
European Medicines Agency. Informed Consent for Paediatric Clinical Trials in Europe 2015
Other Identifiers
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GUITAR
Identifier Type: -
Identifier Source: org_study_id
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PHASE4
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