Overview
Sponsor-declared trial summary
Rheumatoid arthritis
To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients
Key facts
- Sponsor
- Cliniques Universitaires Saint-Luc
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 10 Dec 2019 → ongoing
- Decision date (initial)
- 2024-07-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sanofi-Aventis
External identifiers
- EU CT number
- 2024-514201-61-00
- EudraCT number
- 2019-003138-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients
Secondary objectives 3
- To assess the efficacy and safety and tolerability of Sarilumab compared to TNF BioDMARD prolongation in active RA on a background therapy with MTX over 3 months of treatment
- To evaluate MRI RAMRIS score.
- To analyse incidence and severity of AEs, lab test abnormalities and vital signs according to GCP guidelines and SUSAR reporting.
Conditions and MedDRA coding
Rheumatoid arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1) Males or females (not nursing and not pregnant) at least 18 years of age. Women of child-bearing potential are eligible if they are practicing effective contraceptive measures.
- 2) Subjects must meet the criteria of the 2010 EULAR/ACR criteria for the diagnosis of rheumatoid arthritis
- 3) Subjects must have a disease activity as defined by a tender joint count of > 4, swollen joint count of > 4 from 68 joints and a DAS28-CRP >3.7
- 4) Subjects must be treated with a TNF BioDMARD since 3 months on a background stable dose of MTX
- 5) Subjects must be naive to non TNF BioDMARDs (Abatacept, Tocilizumab, Rituximab and JAK inhibitor)
Exclusion criteria 4
- 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy or women who are pregnant or breastfeeding
- 2) Subjects with a history of cancer within the last five years (other than nonmelanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing.
- 3) Subjects with any serious bacterial infection and at risk for tuberculosis (TB).
- 4) Subjects unable to accept and perform the procedure.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients and ACR 20, 50 and EULAR response at week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Kevzara 200 mg solution for injection in pre-filled syringe
PRD5263361 · Product
- Active substance
- Sarilumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC14 — -
- Marketing authorisation
- EU/1/17/1196/004
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cliniques Universitaires Saint-Luc
- Sponsor organisation
- Cliniques Universitaires Saint-Luc
- Address
- Hippokrateslaan 10, Batiment 54 Batiment 54
- City
- Sint-Lambrechts-Woluwe
- Postcode
- 1200
- Country
- Belgium
Scientific contact point
- Organisation
- Cliniques Universitaires Saint-Luc
- Contact name
- Patrick Durez
Public contact point
- Organisation
- Cliniques Universitaires Saint-Luc
- Contact name
- Patrick Durez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 30 | 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 |
|---|---|---|---|---|---|
| Belgium | 2019-12-10 | 2020-02-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514201-61-00 | 1.2 |
| Protocol (for publication) | D4_Patient facing document_2024-514201-61-00 | 1 |
| Protocol (for publication) | D4_Patient facing document_2024-514201-61-00_2 | 1 |
| Recruitment arrangements (for publication) | SARABIO_2024-514201-61-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_FR_adults | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kevzara | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_BE_FR_2024-514201-61-00 | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-18 | Belgium | Acceptable with conditions 2024-07-30
|
2024-07-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-23 | Belgium | Acceptable with conditions 2024-07-30
|
2026-01-23 |