Trials Sponsors Conditions Drugs Pricing

Conditions

Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

Safety of biological treatment with vedolizumab and infliximab defined by the number of drug-related adverse events (AEs).

Secondary Outcomes (1)

1. Clinical response - decrease in PUCAI value by min. 20 points 2. Clinical remission - PUCAI value < 10 points 3. Mucosal remission - Mayo endoscopic score = 0 4. Clinical response in the total Mayo scale - reduction of at least 3 points 5. Clinical remission in the Mayo total scale - value ≤ 2 points 6. Clinical response in the partial Mayo scale - reduction of at least 2 points 7. Clinical remission in the Mayo partial scale - value ≤ 2 points

Interventions

Entyvio 300 mg powder for concentrate for solution for infusionType not reported

INFLIXIMABType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Entyvio 300 mg powder for concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
INFLIXIMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Entyvio 300 mg powder for concentrate for solution for infusion
Named ingredient: vedolizumab
View registry record
INFLIXIMAB
Named ingredient: Infliximab
View registry record

Eligibility Criteria

Sexall

Age GroupsChild (0-17)

You may qualify if:

Subjects aged 6 to 17 years. 2. A patient with a moderate or severe UC defined as a minimum of 30 points in the PUCAI, diagnosed at least 1 month before the screening visit 3. Subjects who did not respond to standard treatment, lost their response or did not tolerated treatment of at least one of the following agents: corticosteroids (prednison at a dose of 1mg/kg/d with a maximum dose of 40 mg/d, budesonid MMX 9 mg/d) or immunomodulatory drugs (e.g. AZA, 6-MP, MTX, cyclosporin) - When using 5-ASA, corticosteroids, immunomodulatory drugs dosing should remain stable 2 weeks before the study drug administration 4. Patients with a proximal location to the rectum UC (i.e. not limited to rectal inflammation). 5. Mayo Endoscopic Scale score  1 point 6. Subjects with current immunizations in accordance with the adopted immunization program in Poland - vaccination with live vaccines. 7. Informed written consent to participate in the study signed by legal representatives and subjects from 13 years of age

Sponsors & Collaborators

Instytut Pomnik Centrum Zdrowia Dziecka
Type not reportedlead

Study Sites (10)

Wojewódzki Szpital Zespolony – Szpital Specjalistyczny dla Dzieci i Dorosłych w Toruniu

Toruń, 87-100, Poland

Ewa Hapyn6794584 sekretariat@wszz.torun.pl

KLINIKA PEDIATRII, KATEDRY PEDIATRII, WYDZIAŁ NAUK MEDYCZNYCH W KATOWICACH GCZD

Katowice, 40-752, Poland

Sabina Więcek2071700 ped@gczd.katowice.pl

II Katedra i Klinika Pediatrii, Gastroenterologii i Żywienia

Wrocław, 50-369, Poland

Tomasz Pytrus

Central Study Contacts

Mariola Modzelewska

+48228151168 m.modzelewska@ipczd.pl

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

December 29, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-509775-16-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:27:52 UTC

Documents

D1_Protoko badania klinicznego 2023-509775-16_Publiczny

Subjects who were previously treated with any biological drug regardless of indication. 2. Subjects who were previously treated with vedolizumab. 3. Subjects who were previously treated with infliximab 4. Known hypersensitivity to any of the components of study drugs 5. Subjects with active brain/cerebrospinal meninges disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other serious neurological disorders, including stroke, multiple sclerosis, brain cancer or neurodegenerative disease. 6. Subjects who currently require surgical intervention or are expected that they will require surgical intervention due to UC during the study 7. Subjects who have undergone partial or total colectomy or have jejunostomy, ileostomy, colostomy, ileoanalstomy or known permanent bowel stricture 8. Subjects with current diagnosis of unspecified colitis 9. Subjects with clinical features suggesting monogenic very early onset inflammatory bowel disease 10. Presence of active serious infections such as septicemia, abscesses, cytomegalovirus, listeriosis, opportunistic infections. 11. Subjects with moderate or severe heart failure (NYHA class III/IV). 12. individuals with current or past cancer. 13. A subject with other serious co -existing diseases that will limit his/her ability to complete the study 14. Abnormal laboratory tests results: - hemoglobin ≤ 8 g/dl - leukocytes ≤ 2.5 x 10*3/ul. - lymphopenia <0.3 x 10*3/ul. - ALT and/or AST ≥ 3 x upper limit of normal - positive Quantiferon test -signs of active infection confirmed by a positive result in a stool sample for Clostridium difficile and/or stool culture for alarm pathogens -positive HBsAg test -positive anti-HCV antibodies test -positive HIV Ag/Ab test 15. Pregnancy, breastfeeding, or refusal to use effective methods of contraception or sexual abstinence in women of childbearing potential during the study 16. Use of another investigational drug within 6 months before study entry or participation in other studies at the time of screening

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations