Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
8
Arthritis rheumatoid
To estimate the average value of the minimal necessary adalimumab trough concentrations to maintain remission in patients in remission of RA for at least 6 months treated by adalimumab.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Saint Etienne
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 3 Dec 2024 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- French Ministry of Health
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To estimate the average value of the minimal necessary adalimumab trough concentrations to maintain remission in patients in remission of RA for at least 6 months treated by adalimumab.
Secondary objectives 1
- To assess in both groups rate of anti-adalimumab antibodies development and tolerance
Conditions and MedDRA coding
Arthritis rheumatoid
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Single arm trial
|
Not Applicable | None | Adalimumab: Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months without changes in other treatments. Time during injection will be increased every 3 months by 50% if no disease flare is clinically detected. In case of disease flare, adalimumab will be re-escalated to the previous step until remission is achieved again |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patient over 18 years of age
- Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria
- Remission according to DAS28<2.6 for at least 6 months
- Patients with ongoing adalimumab treatment for at least 6 months. the patient according to one the following 2 strategies: - (ADA 40 mg every other week) according to the standard regimen OR - ADA 40 mg every 3 week
- Affiliated person or beneficiary of a social security scheme
- Informed consent signed by the patient after information
- A negative highly sensitive pregnancy test for women of Childbearing Potential
Exclusion criteria 5
- Incapacity or refusal to understand and / or sign informed consent to participate in the study
- Existing pregnancy, lactation, or intended pregnancy within the next 15 months
- Fibromyalgia associated to RA
- Any dose of prednisone for RA treatment 6 months before inclusion
- Patient deprived of liberty or patient under guardianship or curatorship
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess the primary objective of the study, a regression analysis is necessary to characterize the relationship between i) the risk of RA flare and ii) adalimumab trough concentrations. RA flare-up : 1/ a DAS28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (∆DAS28) of 0.6 or greater for patients with low disease activity (2.6
Secondary endpoints 1
- Presence of anti-adalimumab antibodies will be measured at each visit and at each disease flare. Tolerance will be actively collected at each study visit with an emphasis on any type of infection. All patients will note every infection to a booklet to reduce the memorisation bias.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Humira 40 mg solution for injection in pre-filled syringe
PRD5952356 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/002
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- Avenue Albert Raimond
- City
- Saint Priest En Jarez
- Postcode
- 42270
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- project manager
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- project manager
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 60 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Rhumatologie, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Centre Hospitalier Regional Universitaire De Tours
Rhumatologie, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Universitaire Reims
Rhumatologie, Rue Du General Koenig, 51092, Reims Cedex
Hopitaux Universitaires Pitie Salpetriere
Rhumatologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Departemental Vendee
Rhumatologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Clinique De L Infirmerie Protestante
Rhumatologie, 1-3 Chemin du Penthod, 69300, CALUIRE-ET-CUIRE
Centre Hospitalier Universitaire De Saint Etienne
Rhumatologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Groupement Des Hopitaux De L'Institut Catholique De Lille
Rhumatologie, 115 Rue Du Grand But, Bp 50249 Lille, Lomme Cedex
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 |
|---|---|---|---|---|---|
| France | 2024-12-03 | 2024-12-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514313-35-00 | 3 |
| Protocol (for publication) | D1_Protocol_2024-514313-35-00_TC | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC_Patient | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Adalimumab | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS_2024-514313-35-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS_2024-514313-35-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS_2024-514313-35-00_TC | 3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | France | Acceptable 2024-09-19
|
2024-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-04 | France | Acceptable 2025-05-07
|
2025-05-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-13 | France | Acceptable 2025-12-08
|
2025-12-09 |