Ulcerative ColitisNCT05430412
CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
A study testing Adacolumn in people with Ulcerative Colitis, run by Adacyte Therapeutics SL at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Adacolumn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 11 Jan 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Oscar Segarra
Oscar Segarra
- Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid
Laura María Palomino Pérez
Laura María Palomino Pérez
- Recruiting
Hospital Materno-Infantil del H.U.R. de Málaga
Málaga
Víctor Manuel Navas López
Víctor Manuel Navas López
- Recruiting
Hospital H. Sant Joan de Déu
Sant Joan Despí, Barcelona
Francisco Javier Martin Carpi
Francisco Javier Martin Carpi
- Recruiting
Hospital U. Ntra Señora de Candelaria
Santa Cruz de Tenerife
José Ramón Alberto Alonso
José Ramón Alberto Alonso
- Recruiting
Complejo H. Regional Virgen Del Rocío
Seville
Alejandro Rodriguez
Alejandro Rodriguez
- Recruiting
Hospital Universitari I Politècnic La Fe
Valencia
Ester Donat
Ester Donat
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Coimbra
Coimbra
Ricardo Ferreira
Ricardo Ferreira
- Recruiting
Hospital Santa Maria
Lisbon
Ana Isabel Lopes
Ana Isabel Lopes
- Recruiting
Hospital Soa Joao
Porto
Eunice Trindade
Eunice Trindade
About this study
Official title: Clinical Trial to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
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.
Read the 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):
- Quantification of IFX trough and ATI levels, and description of the IFX dose at baseline, 12 and 40 weeks of follow-up.
- Measurement of PUCAI score at baseline, 12 and 40 weeks of follow-up.
- Patients maintaining clinical response off steroids, 12 and 40 weeks of follow-up.
- Patients experiencing flares-ups during the study period.
- 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.
- Measurement of C-reactive protein, erythrocyte sedimentation rate, hemoglobin, albumin, platelet levels at baseline, 12 and 40weeks of follow-up.
- Quantification of leucocyte counts in peripheral blood at baseline, 12 and 40 weeks of followup.
- Monitoring of AEs during the study period
- Conditions
- Ulcerative Colitis
- Being tested
- Adacolumn
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdacolumnDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Adacolumn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Description of IFX blood and ATI levels as continuous variables at baseline visit, Visit 11 (12 weeks) and Visit 18 (40 weeks) will be performed. Their variation between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be analysed by means of absolute and relative change. Moreover, description of IFX dose by kilogram will be described in these visits
Measured: 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.
Description of PUCAI score as continuous variable at baseline visit, Visit 11 (12 weeks) and Visit 18 (40 weeks) will be performed. Its variation between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be analysed by means of absolute and relative change
Measured: 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.
Description of the number and percentage of patients changing the behaviour of steroids treatment (use or not use) from baseline visit to Visit 11 (12 weeks) and from baseline visit to Visit 18 (40 weeks) will be computed. Furthermore, comparison between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be performed
Measured: 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.
Description of the number of patients experienced flare-ups and the accumulate number of flare-ups from baseline visit to Visit 11 and from baseline visit to Visit 18 will be computed.
Measured: 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.
Description of faecal calprotectin level as continuous variable at baseline visit, Visit 11 (12 weeks) and Visit 18 (40 weeks) will be performed. Their variation between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be analysed by means of absolute and relative change. As levels of faecal calprotectin > 150 μg/g are associated with clinical remission, the number and percentage of patients with faecal calprotectin > 150 μg/g will be described. Furthermore, comparison between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be performed.
Measured: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
To monitor the evolution of biochemical markers of inflammatory activity in UC and other laboratory parameters. Measurement of C-reactive protein, ESR, haemoglobin, albumin, platelet levels, PT, granulocytes at baseline, 12(V11) and 40 weeks(V18)
Description of CRP, ESR, haemoglobin, albumin platelet levels, PT and granulocytes as continuous variables at baseline visit, Visit 11 (12 weeks) and Visit 18 (40 weeks) will be performed. Their variation between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be analysed by means of absolute and relative change.
Measured: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
To determine the evolution of leucocyte counts in peripheral blood during the study period. Quantification of leucocyte counts in peripheral blood at baseline, 12 and 40 weeks of follow-up.
Description of leucocyte counts as continuous variable at Baseline visit, Visit 11 (12 weeks) and Visit 18 (40 weeks) will be performed. Its variation between visits (baseline vs. Visit 11 and baseline vs. Visit 18) will be analysed by means of absolute and relative change
Measured: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
To evaluate the safety of Adacolumn® during the study period, all the recorded AEs will be described by:
- The number of patients who suffer them
- The number of patients who suffer AEs related to Adacolumn®
- Their incidence and duration
- Their relationship with Adacolumn®
- Seriousness, severity, ongoing and outcome This analysis will be done on those patients belonging to the safety sample
Measured: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start11 Jan 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adacyte Therapeutics SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Martín de Carpi, Study chair, Hospital San Joan de DeuJorge Manuel Bastos Amil Dias, Study chair, CHU Sao Joao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430412
- Sponsor's protocol ID
- GUITAR
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saniabadi AR, Hanai H, Takeuchi K, Umemura K, Nakashima M, Adachi T, Shima C, Bjarnason I, Lofberg R. Adacolumn, an adsorptive carrier based granulocyte and monocyte apheresis device for the treatment of inflammatory and refractory diseases associated with leukocytes. Ther Apher Dial. 2003 Feb;7(1):48-59. doi: 10.1046/j.1526-0968.2003.00012.x.
PubMed 12921115Shimoyama T, Sawada K, Hiwatashi N, Sawada T, Matsueda K, Munakata A, Asakura H, Tanaka T, Kasukawa R, Kimura K, Suzuki Y, Nagamachi Y, Muto T, Nagawa H, Iizuka B, Baba S, Nasu M, Kataoka T, Kashiwagi N, Saniabadi AR. Safety and efficacy of granulocyte and monocyte adsorption apheresis in patients with active ulcerative colitis: a multicenter study. J Clin Apher. 2001;16(1):1-9. doi: 10.1002/jca.1000.
PubMed 11309823Saniabadi AR, Tanaka T, Yamamoto T, Kruis W, Sacco R. Granulomonocytapheresis as a cell-dependent treatment option for patients with inflammatory bowel disease: Concepts and clinical features for better therapeutic outcomes. J Clin Apher. 2019 Feb;34(1):51-60. doi: 10.1002/jca.21670. Epub 2018 Nov 8.
PubMed 30407662Yoshimura N, Tadami T, Kawaguchi T, Sako M, Yoshimoto H, Yamaka T, Takazoe M. Processed blood volume impacts clinical efficacy in patients with ulcerative colitis undergoing adsorptive depletion of myeloid lineage leucocytes. J Gastroenterol. 2012 Jan;47(1):49-55. doi: 10.1007/s00535-011-0464-0. Epub 2011 Sep 14.
PubMed 21915624Suzuki Y, Yoshimura N, Saniabadi AR, Saito Y. Selective granulocyte and monocyte adsorptive apheresis as a first-line treatment for steroid naive patients with active ulcerative colitis: a prospective uncontrolled study. Dig Dis Sci. 2004 Apr;49(4):565-71. doi: 10.1023/b:ddas.0000026299.43792.ae.
PubMed 15185858Suzuki Y, Yoshimura N, Fukuda K, Shirai K, Saito Y, Saniabadi AR. A retrospective search for predictors of clinical response to selective granulocyte and monocyte apheresis in patients with ulcerative colitis. Dig Dis Sci. 2006 Nov;51(11):2031-8. doi: 10.1007/s10620-006-9199-9. Epub 2006 Sep 27.
PubMed 17004123Hanai H, Watanabe F, Takeuchi K, Iida T, Yamada M, Iwaoka Y, Saniabadi A, Matsushita I, Sato Y, Tozawa K, Arai H, Furuta T, Sugimoto K, Bjarnason I. Leukocyte adsorptive apheresis for the treatment of active ulcerative colitis: a prospective, uncontrolled, pilot study. Clin Gastroenterol Hepatol. 2003 Jan;1(1):28-35. doi: 10.1053/jcgh.2003.50005.
PubMed 15017514Saez-Gonzalez E, Moret I, Alvarez-Sotomayor D, Diaz-Jaime FC, Cerrillo E, Iborra M, Nos P, Beltran B. Immunological Mechanisms of Adsorptive Cytapheresis in Inflammatory Bowel Disease. Dig Dis Sci. 2017 Jun;62(6):1417-1425. doi: 10.1007/s10620-017-4577-z. Epub 2017 Apr 21.
PubMed 28432476Dignass A, Akbar A, Hart A, Subramanian S, Bommelaer G, Baumgart DC, Grimaud JC, Cadiot G, Makins R, Hoque S, Bouguen G, Bonaz B. Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results. J Crohns Colitis. 2016 Jul;10(7):812-20. doi: 10.1093/ecco-jcc/jjw032. Epub 2016 Jan 27.
PubMed 26818659Dignass A, Akbar A, Baumgart DC, Bommelaer G, Bouguen G, Cadiot G, Gillessen A, Grimaud JC, Hart A, Hoque S, Makins R, Michiels C, Moreau J, Premchand P, Ramlow W, Schanz S, Subramanian S, von Tirpitz C, Bonaz B. Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis. Scand J Gastroenterol. 2018 Apr;53(4):442-448. doi: 10.1080/00365521.2018.1447598. Epub 2018 Mar 7.
PubMed 29513111Martin de Carpi J, Vilar P, Prieto G, Garcia Novo MD, Ribes C, Varea V. Safety and efficacy of granulocyte and monocyte adsorption apheresis in paediatric inflammatory bowel disease: a prospective pilot study. J Pediatr Gastroenterol Nutr. 2008 Apr;46(4):386-91. doi: 10.1097/MPG.0b013e31815604e5.
PubMed 18367949Ruuska T, Kuster P, Grahnquist L, Lindgren F, Wewer AV. Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis. World J Gastroenterol. 2016 May 7;22(17):4389-96. doi: 10.3748/wjg.v22.i17.4389.
PubMed 27158208Golbabapour S, da Silva LM, Athanasiou A. Immunological Aspects of Gastrointestinal Diseases. Gastroenterol Res Pract. 2017;2017:2891574. doi: 10.1155/2017/2891574. Epub 2017 May 17. No abstract available.
PubMed 28620414Ghosh S, Shand A, Ferguson A. Ulcerative colitis. BMJ. 2000 Apr 22;320(7242):1119-23. doi: 10.1136/bmj.320.7242.1119. No abstract available.
PubMed 10775225Nedelciuc O, Pintilie I, Dranga M, Mihai C, Prelipcean CC. Quality of life in patients with ulcerative colitis. Rev Med Chir Soc Med Nat Iasi. 2012 Jul-Sep;116(3):756-60.
PubMed 23272523
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05430412
- Acronym / sponsor ID
- GUITAR
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Adacyte Therapeutics SLIndustry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Quantification of IFX trough and ATI levels, and description of the IFX dose at baseline, 12 and 40 weeks of follow-up.
- Measurement of PUCAI score at baseline, 12 and 40 weeks of follow-up.
- Patients maintaining clinical response off steroids, 12 and 40 weeks of follow-up.
- Patients experiencing flares-ups during the study period.
- 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.
- Measurement of C-reactive protein, erythrocyte sedimentation rate, hemoglobin, albumin, platelet levels at baseline, 12 and 40weeks of follow-up.
- Quantification of leucocyte counts in peripheral blood at baseline, 12 and 40 weeks of followup.
- Monitoring of AEs during the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adacolumn | Experimental | Device: AdacolumnAdacolumn 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdacolumnThe 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). | Device | Adacolumn |
Primary outcome
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
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
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
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
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
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
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
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
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.
8 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
To monitor the evolution of biochemical markers of inflammatory activity in UC and other laboratory parameters. Measurement of C-reactive protein, ESR, haemoglobin, albumin, platelet levels, PT, granulocytes at baseline, 12(V11) and 40 weeks(V18)
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
To determine the evolution of leucocyte counts in peripheral blood during the study period. Quantification of leucocyte counts in peripheral blood at baseline, 12 and 40 weeks of follow-up.
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
To evaluate the safety of Adacolumn® during the study period, all the recorded AEs will be described by:
Time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 12921115Saniabadi AR, Hanai H, Takeuchi K, Umemura K, Nakashima M, Adachi T, Shima C, Bjarnason I, Lofberg R. Adacolumn, an adsorptive carrier based granulocyte and monocyte apheresis device for the treatment of inflammatory and refractory diseases associated with leukocytes. Ther Apher Dial. 2003 Feb;7(1):48-59. doi: 10.1046/j.1526-0968.2003.00012.x.
- Background: PubMed 11309823Shimoyama T, Sawada K, Hiwatashi N, Sawada T, Matsueda K, Munakata A, Asakura H, Tanaka T, Kasukawa R, Kimura K, Suzuki Y, Nagamachi Y, Muto T, Nagawa H, Iizuka B, Baba S, Nasu M, Kataoka T, Kashiwagi N, Saniabadi AR. Safety and efficacy of granulocyte and monocyte adsorption apheresis in patients with active ulcerative colitis: a multicenter study. J Clin Apher. 2001;16(1):1-9. doi: 10.1002/jca.1000.
- Background: PubMed 30407662Saniabadi AR, Tanaka T, Yamamoto T, Kruis W, Sacco R. Granulomonocytapheresis as a cell-dependent treatment option for patients with inflammatory bowel disease: Concepts and clinical features for better therapeutic outcomes. J Clin Apher. 2019 Feb;34(1):51-60. doi: 10.1002/jca.21670. Epub 2018 Nov 8.
- Background: PubMed 21915624Yoshimura N, Tadami T, Kawaguchi T, Sako M, Yoshimoto H, Yamaka T, Takazoe M. Processed blood volume impacts clinical efficacy in patients with ulcerative colitis undergoing adsorptive depletion of myeloid lineage leucocytes. J Gastroenterol. 2012 Jan;47(1):49-55. doi: 10.1007/s00535-011-0464-0. Epub 2011 Sep 14.
- Background: PubMed 15185858Suzuki Y, Yoshimura N, Saniabadi AR, Saito Y. Selective granulocyte and monocyte adsorptive apheresis as a first-line treatment for steroid naive patients with active ulcerative colitis: a prospective uncontrolled study. Dig Dis Sci. 2004 Apr;49(4):565-71. doi: 10.1023/b:ddas.0000026299.43792.ae.
- Background: PubMed 17004123Suzuki Y, Yoshimura N, Fukuda K, Shirai K, Saito Y, Saniabadi AR. A retrospective search for predictors of clinical response to selective granulocyte and monocyte apheresis in patients with ulcerative colitis. Dig Dis Sci. 2006 Nov;51(11):2031-8. doi: 10.1007/s10620-006-9199-9. Epub 2006 Sep 27.
- Background: PubMed 15017514Hanai H, Watanabe F, Takeuchi K, Iida T, Yamada M, Iwaoka Y, Saniabadi A, Matsushita I, Sato Y, Tozawa K, Arai H, Furuta T, Sugimoto K, Bjarnason I. Leukocyte adsorptive apheresis for the treatment of active ulcerative colitis: a prospective, uncontrolled, pilot study. Clin Gastroenterol Hepatol. 2003 Jan;1(1):28-35. doi: 10.1053/jcgh.2003.50005.
- Background: PubMed 28432476Saez-Gonzalez E, Moret I, Alvarez-Sotomayor D, Diaz-Jaime FC, Cerrillo E, Iborra M, Nos P, Beltran B. Immunological Mechanisms of Adsorptive Cytapheresis in Inflammatory Bowel Disease. Dig Dis Sci. 2017 Jun;62(6):1417-1425. doi: 10.1007/s10620-017-4577-z. Epub 2017 Apr 21.
- Background: PubMed 26818659Dignass A, Akbar A, Hart A, Subramanian S, Bommelaer G, Baumgart DC, Grimaud JC, Cadiot G, Makins R, Hoque S, Bouguen G, Bonaz B. Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results. J Crohns Colitis. 2016 Jul;10(7):812-20. doi: 10.1093/ecco-jcc/jjw032. Epub 2016 Jan 27.
- Background: PubMed 29513111Dignass A, Akbar A, Baumgart DC, Bommelaer G, Bouguen G, Cadiot G, Gillessen A, Grimaud JC, Hart A, Hoque S, Makins R, Michiels C, Moreau J, Premchand P, Ramlow W, Schanz S, Subramanian S, von Tirpitz C, Bonaz B. Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis. Scand J Gastroenterol. 2018 Apr;53(4):442-448. doi: 10.1080/00365521.2018.1447598. Epub 2018 Mar 7.
- Background: PubMed 18367949Martin de Carpi J, Vilar P, Prieto G, Garcia Novo MD, Ribes C, Varea V. Safety and efficacy of granulocyte and monocyte adsorption apheresis in paediatric inflammatory bowel disease: a prospective pilot study. J Pediatr Gastroenterol Nutr. 2008 Apr;46(4):386-91. doi: 10.1097/MPG.0b013e31815604e5.
- Background: PubMed 27158208Ruuska T, Kuster P, Grahnquist L, Lindgren F, Wewer AV. Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis. World J Gastroenterol. 2016 May 7;22(17):4389-96. doi: 10.3748/wjg.v22.i17.4389.
- Adacyte Therapeutics Therapeutics. Adacolumn®. Instructions for useLink provided by the sponsor.
- Adacyte TherapeuticsLink provided by the sponsor.
- European Commission. Ethical Considerations for Clinical TrialsLink provided by the sponsor.
- European Medicines Agency. Informed Consent for Paediatric Clinical Trials in Europe 2015Link provided by the sponsor.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Javier Martín de Carpi study chair
Hospital San Joan de Deu
Jorge Manuel Bastos Amil Dias study chair
CHU Sao Joao
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adacolumn in people with Ulcerative Colitis, run by Adacyte Therapeutics SL at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Zapico (34 687 975 712, p.zapico@adacyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430412, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.