Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
ulcerative colitis
To compare the CIMT after 3 months of therapy in ulcerative colitis in patients treated by anti-TNF, vedolizumab, and tofacitinib
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-09-10
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- pfizer
External identifiers
- EU CT number
- 2024-517314-15-00
- EudraCT number
- 2020-004391-18
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Therapy
To compare the CIMT after 3 months of therapy in ulcerative colitis in patients treated by anti-TNF, vedolizumab, and tofacitinib
Secondary objectives 7
- To compare the arterial stiffness after 3 months of therapy in UC in patients treated by anti-TNF, vedolizumab, and tofacitinib.
- To compare the CIMT and arterial stiffness after 12 months of therapy in UC, and the evolution of them, in patients treated by anti-TNF, vedolizumab, and tofacitinib.
- To compared the biomarkers of endothelial dysfunction and coagulation parameters at baseline and at 3 and 12 months and in patients responders and non-responders in patients treated by anti-TNF, vedolizumab, and tofacitinib.
- To compared the coagulation parameters at baseline and at 3 and 12 months and in patients responders and nonresponders to biologics in patients treated by anti-TNF, vedolizumab, and tofacitinib.
- To compared the levels of neutrophil extracellular traps (NETs) at baseline and at 3 and 12 months and in patients responders and non-responders in patients treated by antiTNF, vedolizumab, and tofacitinib.
- To compare the Framingham score, the 10-year atherosclerotic CV disease risk (ASCVD) indices and the SCORE at baseline and at 3 and 12 months in patients responders and non responders to UC therapy
- To compared the lipids levels at baseline and at 3 and 12 months and in patients responders and non-responders to UC therapy
Conditions and MedDRA coding
ulcerative colitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Ulcerative colitis evolving for at least 6 months
- Patient older than 18 years
- Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib
- Patient covered by French national health insurance
- Written informed consent
Exclusion criteria 6
- Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period.
- Patients with a cardiovascular event such as myocardial infarction and stroke
- Diabetic patient
- Pregnant women or breastfeeding
- Minor
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Carotid intima media thickness (CIMT)
Secondary endpoints 7
- Aortic pulse wave velocity (aPWV) / arterial stiffness
- Augmentation index (AIx)
- Framingham score, the 10-year atherosclerotic CV disease risk (ASCVD) indices (reflect of the cardiovascular risk) and the SCORE score
- Ulcerative colitis activity score /Mayo Score
- Lipids parameters (HDL, LDL, TC, TG)
- Arterial tension and systolic pressure index
- Endothelial function / Coagulation parameters
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Entyvio 300 mg powder for concentrate for solution for infusion
PRD1598541 · Product
- Active substance
- Vedolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/001
- MA holder
- TAKEDA PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
XELJANZ 5 mg film-coated tablets
PRD4862227 · Product
- Active substance
- Tofacitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 2240 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA29 — -
- Marketing authorisation
- EU/1/17/1178/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6483369 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
PRD7075278 · Product
- Active substance
- Golimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- INTRAVENOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1400 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB06 — -
- Marketing authorisation
- EU/1/09/546/009
- MA holder
- JANSSEN BIOLOGICS B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
AMGEVITA 40 mg solution for injection in pre-filled syringe
PRD11345143 · Product
- Active substance
- Adalimumab
- Substance synonyms
- ABP 501, BI 695501, MSB11022
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 2080 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/12/1164/011
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- FUMERY MATHURIN
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- GUENEBEM KOSSI Fulvia
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Amiens Picardie
HEPATO-GASTROLOGY, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOLE_2024-517314-15-00 | 2 |
| Recruitment arrangements (for publication) | NA | 1 |
| Subject information and informed consent form (for publication) | L1-SIS_and_ICF_PATIENT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC vedolizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ golimumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ Infliximab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Adalimumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_tofacitinib | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOLE__SYNOPSIS_FR_2024-517314-15-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | France | Acceptable 2024-09-07
|
2024-09-10 |