VEDOLIZUMAB for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- 1. Subjects aged 6 to 17 years.\n- 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\n- 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\n- 4. Patients with a proximal location to the rectum UC (i.e. not limited to rectal inflammation).\n- 5. Mayo Endoscopic Scale score  1 point\n- 6. Subjects with current immunizations in accordance with the adopted immunization program in Poland - vaccination with live vaccines.\n- 7. Informed written consent to participate in the study signed by legal representatives and subjects from 13 years of age"}

Exclusion criteria

• {"criterion_text":"- 1. Subjects who were previously treated with any biological drug regardless of indication.\n- 2. Subjects who were previously treated with vedolizumab.\n- 3. Subjects who were previously treated with infliximab\n- 4. Known hypersensitivity to any of the components of study drugs\n- 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.\n- 6. Subjects who currently require surgical intervention or are expected that they will require surgical intervention due to UC during the study\n- 7. Subjects who have undergone partial or total colectomy or have jejunostomy, ileostomy, colostomy, ileoanalstomy or known permanent bowel stricture\n- 8. Subjects with current diagnosis of unspecified colitis\n- 9. Subjects with clinical features suggesting monogenic very early onset inflammatory bowel disease\n- 10. Presence of active serious infections such as septicemia, abscesses, cytomegalovirus, listeriosis, opportunistic infections.\n- 11. Subjects with moderate or severe heart failure (NYHA class III/IV).\n- 12. individuals with current or past cancer.\n- 13. A subject with other serious co -existing diseases that will limit his/her ability to complete the study\n- 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\n- 15. Pregnancy, breastfeeding, or refusal to use effective methods of contraception or sexual abstinence in women of childbearing potential during the study\n- 16. Use of another investigational drug within 6 months before study entry or participation in other studies at the time of screening"}

Primary endpoints

• {"endpoint_text":"- Safety of biological treatment with vedolizumab and infliximab defined by the number of drug-related adverse events (AEs).","definition_or_measurement_approach":"Defined by the number of drug-related adverse events (AEs)."}

Secondary endpoints

• {"endpoint_text":"- 1. Clinical response - decrease in PUCAI value by min. 20 points\n- 2. Clinical remission - PUCAI value < 10 points\n- 3. Mucosal remission - Mayo endoscopic score = 0\n- 4. Clinical response in the total Mayo scale - reduction of at least 3 points\n- 5. Clinical remission in the Mayo total scale - value ≤ 2 points\n- 6. Clinical response in the partial Mayo scale - reduction of at least 2 points\n- 7. Clinical remission in the Mayo partial scale - value ≤ 2 points","definition_or_measurement_approach":"Clinical response/remission definitions provided in endpoint text: e.g. clinical response = decrease in PUCAI by ≥20 points; clinical remission = PUCAI <10; mucosal remission = Mayo endoscopic score = 0; other endpoints defined by point reductions or threshold values on total or partial Mayo scales as stated."}

Poland

Earliest CTIS Part Ii Submission Date

16-04-2024

Latest Decision Or Authorization Date

06-05-2024

Processing Time Days

20

Number Of Sites

10

Number Of Participants

66

Primary sponsor

Full Name

Instytut Pomnik Centrum Zdrowia Dziecka

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland