Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
224
Countries
1
Sites
27
Adults patients suffering from rheumatoid arthritis and in adequate response to one or two targeted treatments.
Compare tocilizumab versus abatacep administered subcutaneously efficacy in inadequate responder patients to one or two targeted treaments.
Key facts
- Sponsor
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 23 Jan 2018 → 29 Jan 2026
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- DGOS (PHRC-N 2016)
External identifiers
- EU CT number
- 2024-515600-39-00
- EudraCT number
- 2017-000947-41
- ClinicalTrials.gov
- NCT03227419
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
Compare tocilizumab versus abatacep administered subcutaneously efficacy in inadequate responder patients to one or two targeted treaments.
Secondary objectives 4
- 1/ Compare disease progression
- 2/ Compare treatments response and tolerance
- 3/ Evaluate radiobiological criteria to provide pathophysiological explanations to differential responses between drugs.
- 4/ Compare treatment failure rates between groups
Conditions and MedDRA coding
Adults patients suffering from rheumatoid arthritis and in adequate response to one or two targeted treatments.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10039075 | Rheumatoid arthritis and associated conditions | 10021428 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- age >18 years
- RA according to the ACR/EULAR 2010 criteria
- inadequate response to a administered first-line or second line of targeted treatment defined as moderate to high disease activity (DAS28- ESR>3.2 and CDAI>10) after at least 3 months of treatment
- beneficiary of the French National Health Insurance Fund
- signed informed consent form
- for women of childbearing age: effective contraception during treatment period with engagement to continue such contraception for 14 weeks after last administration
Exclusion criteria 6
- counter-indication for one or other of the two drugs under study
- Patient receiving a cortisteroid therapy over 15mg/day prednison equivalent for more than 4 weeks
- failure to a first or second line of targeted treatment
- Prior treatment by tocilizumab, sarilumab or abatacept
- breastfeeding woman
- Prior treatments accepted are TNF alpha inhibitor, rituximab and jak inhibitors
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evolution of the Clinical Disease Activity Index (CDAI) at 6 months. The CDAI is a composite score combining clinical items only: Tender 28- joint count, Swollen 28-joint count, Patient Global Disease (PGA), Evaluator's Global Disease Activity (EGA). This score provides a numerical assessment reflecting disease activity independently of acute phase reactants.
Secondary endpoints 4
- 1/ Secondary outcomes will assess treatment response. Comparisons will be made between the baseline level (M0) and the level observed at 3, 6 and 12 months for : - DAS28-ESR and DAS28-CRP - SDAI : - HAQ, SF-36 FLARE-RA quality of life score - PGA and EGA VAS - CDAI and DAS28-ESR LDA (low disease activity) - Proportion of patients achieving good or moderate European League Against Rheumatism (EULAR) therapeutic response (DS28-ESR) - Proportion of patients achieving ACR20, ACR50, and ACR70 respons
- 2/ Tolerance observed at 3, 6 and 12 months - Proportion of patients presenting at least one side effect, according to NCI-CTCAE v4.0 scale: (Platelets, AST/ALT, Triglycerides, Neutropenia) - Rates of treatment withdrawals for intolerance - Rates of treatment withdrawals for intolerance requiring in-hospital care - Rate of rescue medication use authorized by the protocol and treatment dose
- 3/ Radiobiological criteria for a better understanding of pathophysiological phenomena: - changes in joint US-Doppler synovitis and Doppler hyperemia grade of the hands and wrists at 6 months - changes in Sharp score of hands, wrists and feets radiographs at 12 months - change in Vascular Endothelial Growth Factor (VEGF) levels at 3 and 6 months - changes in interleukin-6 plasma levels at 6 months
- 4/ The treatment failure rate is defined at 3, 6 and 12 months by :o a change in treatment between the assessment visit and the previous visit (apart from breaks ≤ 30d, discontinuation without relapse ≤ 30d, and dose modification) o and/or CDAI > 10 for the treatment considered at the assessment visit o and/or corticosteroid therapy > 10 mg/d prior to the assessment visit, and past 3 months o and/or cortisone derivative infiltration prior to the assessment visit, and past 3 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2316719 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/010
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2316716 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2316717 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/005
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2316715 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/006
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2316718 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/008
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2333402 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/007
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD2333397 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.86 mg milligram(s)
- Max total dose
- 6500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/009
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 162 mg solution for injection in pre-filled syringe.
PRD2154619 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 23.14 mg milligram(s)
- Max total dose
- 8424 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/008
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 162 mg solution for injection in pre-filled syringe.
PRD1576593 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 23.14 mg milligram(s)
- Max total dose
- 8424 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/007
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupement Des Hopitaux De L'Institut Catholique De Lille
- Sponsor organisation
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Address
- 115 Rue Du Grand But, Bp 50249 Lille, Lille, Lille Bp 50249 Lille Lille
- City
- Lomme Cedex
- Postcode
- 59462
- Country
- France
Scientific contact point
- Organisation
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Contact name
- Coordinating investigator
Public contact point
- Organisation
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Contact name
- Clinical trial information desk
Locations
1 EU/EEA country · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 224 | 27 |
| Rest of world | — | 0 | — |
Investigational sites
Groupement Des Hopitaux De L'Institut Catholique De Lille
Service de Rhumatologie, 115 Rue Du Grand But, Bp 50249 Lille, Lomme Cedex
CHU de Lille - Hôpital Roger Salengro
Service de Rhumatologie, 2 Avenue Emilie Laine, 59037, LILLE
APHP - Hôpital Universitaire Pitié-Salpêtrière
Service de Rhumatologie, 47-83 Boulevard de l'hôpital, 75013, PARIS
Hôpital Bicêtre -APHP
Service de Rhumatologie, 78 Rue du Général Leclerc, 94270, Le Kremlin-Bicêtre
Hôpital Lariboisière - APHP
Service de Rhumatologie, 2 Rue Ambroise Paré, 75010, Paris
CHU de Rouen - Hôpital de Bois Guillaume
Service de Rhumatologie, Pavillon de la Colombière, 76031, ROUEN
CHU de Poitiers
Service de Rhumatologie, 2 Rue de la Milétrie, 86000, POITIERS
Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg
Service de Rhumatologie, Avenue Molière, 67200, Strasbourg
Centre Hospitalier Universitaire De Montpellier
Service de Rhumatologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
CHU Reims – Hôpital Maison Blanche
Service de Rhumatologie, 45 Rue Cognacq- Jay, 51092, REIMS
Centre Hospitalier De Valenciennes
Service de Rhumatologie, 114 Avenue Desandrouin, 59300, Valenciennes
Hôpital Bichat-Claude Bernard - AP-HP
Service de Rhumatologie, 46 rue Henri Huchard, 75018, PARIS
CHU Clermont-Ferrand- Site Gabriel-Montpied
Service de Rhumatologie, 58 rue Montalembert, 63000, Clermont-Ferrand
Hôpital NOVO - Site de Pontoise
Service de Rhumatologie, 6 Avenue de l'Île de France, 95303, Cergy Pontoise
Centre Hospitalier Universitaire Grenoble Alpes
Service de Rhumatologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
CHU de Saint-Etienne
Service de Rhumatologie, Avenue Albert Raimond, 42270, Saint-Priest en Jarez
CHRU de Tours- Hôpital Trousseau
Service de Rhumatologie, Avenue de la République, 37170, Chambray-lès-Tours
Centre Hospitalier Universitaire De Nice
Service de Rhumatologie, 30 Voie Romaine, 06000, Nice
CHD Vendée
Service de Rhumatologie, Boulevard Stephane Moreau 85925 La Roche sur Yon cedex 9, 85925 La Roche sur Yon cedex 9, La Roche sur Yon
Hôpital Avicenne
Service de Rhumatologie, 125 rue de Stalingrad, 93000, Bobigny
Centre hospitalier Jean Rougier
Service de Rhumatologie, 335, rue du Président Wilson, Cahors
Centre Hospitalier Universitaire De Bordeaux
Service de Rhumatologie, Place Amelie Raba Leon, 33000, Bordeaux
Clinique De L'infirmerie Protestante De Lyon
Service de Rhumatologie, 1-3, Chemin du Penthod, Caluire et Cuire
Centre Hospitalier Universitaire d’Orléans
Service de Rhumatologie, 14 avenue de l’hôpital, Cedex 2, Orléans
Centre Hospitalier de Boulogne sur Mer
Service de Rhumatologie, Allée Jacques Monod, France, Boulogne sur Mer
CHRU de Nancy - Hôpitaux de Brabois
Service de Rhumatologie, Rue du Morvan, 54511, Vandoeuvre-les-Nancy
Assistance Publique Hopitaux de Paris – Hopital Cochin
Service de Rhumatologie, 27 Rue du Faubourg Saint-Jacques, 75014, Paris
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 | 2018-01-23 | 2026-01-29 | 2018-01-23 | 2025-01-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | SUNSTAR_PROTOCOLE | 8.0 |
| Recruitment arrangements (for publication) | Blank document | NA |
| Subject information and informed consent form (for publication) | SUNSTAR_ICF | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Orencia | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_RoActemra | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | France | Acceptable 2024-07-31
|
2024-07-31 |