Clinical trial • Gastroenterology
INFLIXIMAB for Ulcerative colitis
Clinical trial of INFLIXIMAB for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 19-08-2024
- First CTIS Authorization Date
- 10-09-2024
Trial design
Patients treated by infliximab, adalimumab, golimumab, vedolizumab, and tofacitinib (no dosing or schedule specified in trial documentation)-controlled trial across 1 site in France.
- Comparator
- Patients treated by infliximab, adalimumab, golimumab, vedolizumab, and tofacitinib (no dosing or schedule specified in trial documentation)
- Target Sample Size
- 100
- Trial Duration For Participant
- 365
Eligibility
Recruits 100 Minors are explicitly excluded ("Minor"); patients deprived of liberty or under judicial protection (guardianship or supervision) are excluded. Written informed consent is required from participants (patients older than 18 years). No mention of assent procedures or age-specific consent documents or languages in the available data..
- Pregnancy Exclusion
- Pregnant women or breastfeeding
- Vulnerable Population
- Minors are explicitly excluded ("Minor"); patients deprived of liberty or under judicial protection (guardianship or supervision) are excluded. Written informed consent is required from participants (patients older than 18 years). No mention of assent procedures or age-specific consent documents or languages in the available data.
Inclusion criteria
- {"criterion_text":"- Ulcerative colitis evolving for at least 6 months"}
- {"criterion_text":"- Patient older than 18 years"}
- {"criterion_text":"- Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib"}
- {"criterion_text":"- Patient covered by French national health insurance"}
- {"criterion_text":"- Written informed consent"}
Exclusion criteria
- {"criterion_text":"- Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period."}
- {"criterion_text":"- Patients with a cardiovascular event such as myocardial infarction and stroke"}
- {"criterion_text":"- Diabetic patient"}
- {"criterion_text":"- Pregnant women or breastfeeding"}
- {"criterion_text":"- Minor"}
- {"criterion_text":"- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Carotid intima media thickness (CIMT)","definition_or_measurement_approach":"CIMT measured and compared after 3 months of therapy in patients treated with anti-TNF, vedolizumab, and tofacitinib (assessment timing: after 3 months as stated in main objective)."}
Secondary endpoints
- {"endpoint_text":"- Aortic pulse wave velocity (aPWV) / arterial stiffness","definition_or_measurement_approach":"Arterial stiffness / aPWV measured and compared after 3 months of therapy (and assessed over 12 months per secondary objectives)."}
- {"endpoint_text":"- Augmentation index (AIx)","definition_or_measurement_approach":"AIx measurement as a marker of arterial function; assessed in study visits (secondary objectives include comparison after 3 and 12 months)."}
- {"endpoint_text":"- Framingham score, the 10-year atherosclerotic CV disease risk (ASCVD) indices (reflect of the cardiovascular risk) and the SCORE score","definition_or_measurement_approach":"Cardiovascular risk scores (Framingham, ASCVD, SCORE) calculated at baseline and compared at 3 and 12 months as stated in secondary objectives."}
- {"endpoint_text":"- Ulcerative colitis activity score /Mayo Score","definition_or_measurement_approach":"UC activity assessed using Mayo Score; compared at study timepoints (baseline, 3 and 12 months as per objectives)."}
- {"endpoint_text":"- Lipids parameters (HDL, LDL, TC, TG)","definition_or_measurement_approach":"Lipid panel (HDL, LDL, total cholesterol, triglycerides) measured at baseline and at 3 and 12 months per secondary objectives."}
- {"endpoint_text":"- Arterial tension and systolic pressure index","definition_or_measurement_approach":"Blood pressure measurements and systolic pressure index assessed at study visits (baseline, 3 and 12 months as implied by objectives)."}
- {"endpoint_text":"- Endothelial function / Coagulation parameters","definition_or_measurement_approach":"Biomarkers of endothelial function and coagulation parameters measured at baseline and at 3 and 12 months and compared between responders and non-responders as stated in secondary objectives."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 59
- Consent Approach
- Written informed consent required from participants. Inclusion criterion specifies patients older than 18 years, so consent provided by the adult participant. Minors are excluded. A subject information and informed consent form document is listed for publication, but no details on languages or age-specific documents are provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
France
- Earliest CTIS Part Ii Submission Date
- 05-09-2024
- Latest Decision Or Authorization Date
- 10-09-2024
- Processing Time Days
- 5
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- HEPATO-GASTROLOGY
- Principal Investigator Name
- Mathurin FUMERY
- Principal Investigator Email
- Fumery.Mathurin@chu-amiens.fr
- Contact Person Name
- Mathurin FUMERY
- Contact Person Email
- Fumery.Mathurin@chu-amiens.fr
- Number Of Participants
- 100
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"pfizer","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Inflectra 100 mg powder for concentrate for solution for infusion
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation information present (prodAuthStatus=2, marketing authorisation number EU/1/13/854/001)
- Maximum Dose
- 5 mg/kg
- Investigational Product Name
- Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
- Active Substance
- GOLIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation information present (prodAuthStatus=2, marketing authorisation number EU/1/09/546/009)
- Maximum Dose
- 40 mg
- Investigational Product Name
- AMGEVITA 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation information present (prodAuthStatus=2, marketing authorisation number EU/1/12/1164/011)
- Maximum Dose
- 40 mg
- Investigational Product Name
- Entyvio 300 mg powder for concentrate for solution for infusion
- Active Substance
- VEDOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation information present (prodAuthStatus=2, marketing authorisation number EU/1/14/923/001)
- Maximum Dose
- 300 mg
- Investigational Product Name
- XELJANZ 5 mg film-coated tablets
- Active Substance
- TOFACITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation information present (prodAuthStatus=2, marketing authorisation number EU/1/17/1178/002)
- Maximum Dose
- 20 mg
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