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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430412
• Other study ID #: GUITAR
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: Adacyte Therapeutics SL
• Contact: Pablo Zapico
• Phone: 34 687 975 712
• Email: p.zapico[@]adacyte.com
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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).

Locations

Country	Name	City	State
Portugal	Hospital Coimbra	Coimbra
Portugal	Hospital Santa Maria	Lisboa
Portugal	Hospital Soa Joao	Oporto
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Infantil Universitario Niño Jesús	Madrid
Spain	Hospital Materno-Infantil del H.U.R. de Málaga	Málaga
Spain	Hospital H. Sant Joan de Déu	Sant Joan Despí	Barcelona
Spain	Complejo H. Regional Virgen Del Rocío	Sevilla
Spain	Hospital U. Ntra Señora de Candelaria	Tenerife
Spain	Hospital Universitari I Politècnic La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Adacyte Therapeutics SL	Adknoma Health Research

Countries where clinical trial is conducted

Portugal,  Spain, 

References & Publications (36)

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Martin 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. — View Citation

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Rodriguez-Lago I, Gomez-Irwin L, Fernandez E, Higuera R, Cabriada JL. Granulocyte-Monocyte Apheresis as an Adjuvant Therapy to Anti-Tumor Necrosis Factor Drugs for Ulcerative Colitis. Ther Apher Dial. 2017 Feb;21(1):26-30. doi: 10.1111/1744-9987.12485. Epub 2017 Jan 11. — View Citation

Rodriguez-Lago I, Sempere L, Gutierrez A, Nunez A, Leo Carnerero E, Hinojosa E, Mora M, Canete F, Manosa M, Herrera C, Beltran B, Fores A, Arjona D, Barreiro-de Acosta M, Khorrami S, Aguirre U, Ginard D, Cabriada JL. Granulocyte-monocyte apheresis: an alternative combination therapy after loss of response to anti-TNF agents in ulcerative colitis. Scand J Gastroenterol. 2019 Apr;54(4):459-464. doi: 10.1080/00365521.2019.1600715. Epub 2019 Apr 14. — View Citation

Rolandsdotter H, Eberhardson M, Fagerberg UL, Finkel Y. Granulocyte and Monocyte Apheresis for Induction of Remission in Children With New-Onset Inflammatory Bowel Colitis. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):84-89. doi: 10.1097/MPG.0000000000001641. — View Citation

Ruemmele FM, Hyams JS, Otley A, Griffiths A, Kolho KL, Dias JA, Levine A, Escher JC, Taminiau J, Veres G, Colombel JF, Vermeire S, Wilson DC, Turner D. Outcome measures for clinical trials in paediatric IBD: an evidence-based, expert-driven practical statement paper of the paediatric ECCO committee. Gut. 2015 Mar;64(3):438-46. doi: 10.1136/gutjnl-2014-307008. Epub 2014 May 12. — View Citation

Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516. Erratum In: N Engl J Med. 2006 May 18;354(20):2200. — View Citation

Ruuska 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. — View Citation

Saez-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. — View Citation

Saniabadi AR, Hanai H, Suzuki Y, Ohmori T, Sawada K, Yoshimura N, Saito Y, Takeda Y, Umemura K, Kondo K, Ikeda Y, Fukunaga K, Nakashima M, Beretta A, Bjarnason I, Lofberg R. Adacolumn for selective leukocytapheresis as a non-pharmacological treatment for patients with disorders of the immune system: an adjunct or an alternative to drug therapy? J Clin Apher. 2005 Oct;20(3):171-84. doi: 10.1002/jca.20046. — View Citation

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. — View Citation

Saniabadi 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. — View Citation

Shimoyama 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. — View Citation

Suzuki 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. — View Citation

Suzuki 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. — View Citation

Tanaka T, Yamamoto T, Sawada K, Sacco R. Treatment options for children and adolescents with inflammatory bowel disease: is granulomonocytapheresis an effective alternative to drug therapy? Expert Rev Gastroenterol Hepatol. 2017 Aug;11(8):749-758. doi: 10.1080/17474124.2017.1341309. Epub 2017 Jun 28. — View Citation

Thanaraj S, Hamlin PJ, Ford AC. Systematic review: granulocyte/monocyte adsorptive apheresis for ulcerative colitis. Aliment Pharmacol Ther. 2010 Dec;32(11-12):1297-306. doi: 10.1111/j.1365-2036.2010.04490.x. Epub 2010 Oct 14. — View Citation

Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007 Aug;133(2):423-32. doi: 10.1053/j.gastro.2007.05.029. Epub 2007 May 21. — View Citation

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. Erratum In: J Pediatr Gastroenterol Nutr. 2020 Dec;71(6):794. — View Citation

Ungar B, Levy I, Yavne Y, Yavzori M, Picard O, Fudim E, Loebstein R, Chowers Y, Eliakim R, Kopylov U, Ben-Horin S. Optimizing Anti-TNF-alpha Therapy: Serum Levels of Infliximab and Adalimumab Are Associated With Mucosal Healing in Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2016 Apr;14(4):550-557.e2. doi: 10.1016/j.cgh.2015.10.025. Epub 2015 Oct 29. — View Citation

Velasco Rodriguez-Belvis M, Viada Bris JF, Palomino Perez L, Munoz Codoceo RA. Regain of Response to Adalimumab in a Steroid-Dependent Pediatric Patient With Ulcerative Colitis After Undergoing Selective Granulocyte and Monocyte Apheresis. Inflamm Bowel Dis. 2019 Jun 18;25(7):e82-e83. doi: 10.1093/ibd/izy404. No abstract available. — View Citation

Yamamoto T, Umegae S, Matsumoto K. Long-term clinical impact of early introduction of granulocyte and monocyte adsorptive apheresis in new onset, moderately active, extensive ulcerative colitis. J Crohns Colitis. 2012 Aug;6(7):750-5. doi: 10.1016/j.crohns.2011.12.009. Epub 2012 Jan 12. — View Citation

Yokoyama Y, Kamikozuru K, Watanabe K, Nakamura S. Inflammatory bowel disease patients experiencing a loss of response to infliximab regain long-term response after undergoing granulocyte/monocyte apheresis: A case series. Cytokine. 2018 Mar;103:25-28. doi: 10.1016/j.cyto.2017.12.030. Epub 2017 Dec 29. — View Citation

Yokoyama Y, Sawada K, Aoyama N, Yoshimura N, Sako M, Hirai F, Kashiwagi N, Suzuki Y. Efficacy of Granulocyte and Monocyte Adsorptive Apheresis in Patients With Inflammatory Bowel Disease Showing Lost Response to Infliximab. J Crohns Colitis. 2020 Sep 16;14(9):1264-1273. doi: 10.1093/ecco-jcc/jjaa051. — View Citation

Yoshimura 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. — View Citation

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. — View Citation

Zitomersky NL, Atkinson BJ, Fournier K, Mitchell PD, Stern JB, Butler MC, Ashworth L, Hauenstein S, Heiner L, Chuang E, Singh S, Bousvaros A. Antibodies to infliximab are associated with lower infliximab levels and increased likelihood of surgery in pediatric IBD. Inflamm Bowel Dis. 2015 Feb;21(2):307-14. doi: 10.1097/MIB.0000000000000284. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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.	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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.	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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.	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)
Secondary	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	Baseline visit vs Visit 11 (12 weeks) (interim analysis). Baseline visit vs Visit 18 (40 weeks) (for final analysis)

External Links

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