Overview
Sponsor-declared trial summary
Inflammatory bowel disease
To evaluate whether subcutaneous vedolizumab therapeutic drug monitoring (TDM)-guided de-escalation will be cost-effective, compared to normal dosing regimen in patients with inflammatory bowel disease in remission.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 14 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517502-28-01
- EudraCT number
- 2022-000837-17
- ClinicalTrials.gov
- NCT20220008
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacoeconomic, Therapy, Pharmacokinetic
To evaluate whether subcutaneous vedolizumab therapeutic drug monitoring
(TDM)-guided de-escalation will be cost-effective, compared to normal dosing regimen in
patients with inflammatory bowel disease in remission.
Conditions and MedDRA coding
Inflammatory bowel disease
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517502-28-00 | Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study | Amsterdam UMC Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- crohn's disease or ulcerative colitis in remission
Exclusion criteria 2
- presence of anti-drug antibodies against vedolizumab
- Patients with short bowel syndrome, an ostomy or a symptomatic stricture
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- cost-effectiveness of therapeutic drug monitoring based drug de-escalation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Entyvio 108 mg solution for injection in pre-filled syringe
PRD8036174 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 7.7 mg milligram(s)
- Max total dose
- 2592 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/003
- MA holder
- TAKEDA PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- S.I. Anjie
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- S.I. Anjie
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 20245175022801 V6_1 24Jun2024 | 6.1 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF adults 20245175022801 V2_3 8Mar2024 | 2.3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_2024-517502-28-01 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-05 | Netherlands | Acceptable 2025-01-14
|
2025-01-14 |