Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders
SUNSTAR
Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial
1 other identifier
interventional
224
1 country
26
Brief Summary
Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invalidating pain and joint destruction, leading to major functional disability. Biological agents have been proposed for patients with RA who have the most severe form of the disease and that are inadequate responder patients to conventional synthetic Disease-modifying antirheumatic drugs (csDMARDs). TNF inhibitors (TNFi) are historically proposed as the first biological DAMRD for inadequate responder patients to csDMARDs. A diverse therapeutic arsenal has become available in recent years with the development of non-anti-TNFα drugs whose mechanisms of action are different from the classical TNFi. This new biotherapy class includes tocilizumab and abatacept, two drugs recently available for subcutaneous administration that enables ambulatory care for patients who would otherwise require repeated in-hospital care. The role of these new treatments in the therapeutic strategy has been emphasized by studies that demonstrated their efficacy as first-line treatments. However, in clinical practice, TNFi remain the most common first-line treatment for the majority of patients, non-anti-TNFα biological agents being reserved for inadequate responder patients. In second line, several studies have investigated therapeutic strategies for inadequate responder patients to TNFi. Current data suggest that it could be wise to change the therapeutic target after failure of a first-line treatment with TNFi. Data about the comparative efficacy of different biologics proposed after failure of a first-line treatment with TNFi are in progress. Meta-analyses from registries and academic trials conducted in France and The Netherlands suggest that non-anti-TNFα agents would have equivalent or superior efficacy compared with a second TNFi. This finding suggests clinicians to switch for an alternate therapeutic target after failure of a first-line TNFi. Data comparing different non-anti-TNFα biologics in inadequate responder patients to TNFi are scare. Industrial trials have demonstrated sustained biological efficacy of non-anti-TNFα biologics after failure of a TNFi. However, there is very little solid data on the direct comparison between them.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2018
Longer than P75 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedSeptember 13, 2023
September 1, 2023
6.6 years
July 19, 2017
September 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to 6 months of the Clinical Disease Activity Index (CDAI)
The CDAI is a composite score combining clinical items only: Tender 28-joint count, Swollen 28-joint count, Patient Global Disease Activity (PGA), Evaluator"s Global Disease Activity (EGA). This score provides a numerical assessment reflecting disease activity independently of cute phase reactants. It will be measured at baseline and 6 months after inclusion
6 months
Secondary Outcomes (26)
Change from baseline of the disease activity score
3, 6 and 12 months
Change from baseline of the Clinical Disease Activity Index (CDAI)
3 and 12 months
Change from baseline of the SDAI
3, 6 and 12 months
Change from baseline in HAQ quality-of-life scores
3, 6 and 12 months
Change from baseline in SF-36 quality-of-life scores
3, 6 and 12 months
- +21 more secondary outcomes
Study Arms (2)
Tocilizumab Prefilled Syringe
EXPERIMENTALMarket approval recommendations will be respected. Treatment should be started within 7 days of randomization. The treatment protocol has no specific provision for treatment adaptation. Treatment will be managed in compliance with the marketing approval recommendations and drug labeling described below.
Abatacept Prefilled Syringe
EXPERIMENTALMarket approval recommendations will be respected. Treatment should be started within 7 days of randomization. The treatment protocol has no specific provision for treatment adaptation. Treatment will be managed in compliance with the marketing approval recommendations and drug labeling described below.
Interventions
Treatment arm: tocilizumab (RoActemra®): 162 mg weekly a schema for therapeutic adaptation with injection intervals determined according to transaminase levels or blood cell counts (neutropenia, thrombopenia) as recommended by Roche-Chugaï (see table below).
Treatment arm: abatacept (Orencia®) 125 mg weekly after an initial dose of 500 mg (body weight \<60kg), 750 mg (body weight between 60 and 100 kg), or 1000 mg (body weight \>100 mg) 24 hours before the first subcutaneous injection.
Eligibility Criteria
You may qualify if:
- age \>18 years
- RA according to the ACR/EULAR 2010 criteria
- inadequate response to a subcutaneously administered first-line TNFi defined as moderate to high disease activity (DAS28-ESR\>3.2 and CDAI\>10) after at least 3 months of treatment with a TNFi
- 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
You may not qualify if:
- counter-indication for one or other of the two drugs under study
- prior failure of the TNFi due to intolerance
- receiving ≥15 mg/day prednisone for more than 4 weeks
- pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Hôpital Saint-Philibert
Lomme, Hauts-de-France, 59462, France
Hôpital Avicenne
Bobigny, France
CHU de Bordeaux
Bordeaux, France
CH de Boulogne-sur-Mer
Boulogne-sur-Mer, France
Ch Cahors
Cahors, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Grenoble Hôpital Sud
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHRU de Lille
Lille, France
Clinique Infirmerie Protestante de Lyon
Lyon, France
CHU de Montpellier
Montpellier, France
CHU Nice
Nice, France
CHU Bichat
Paris, France
Hôpital Cochin
Paris, France
Hôpital de la Pitié-Salpêtrière
Paris, France
Hôpital Lariboisière
Paris, France
CHU de Poitiers
Poitiers, France
CH René-Dubos
Pontoise, France
CHU de Reims
Reims, France
CHU Rouen
Rouen, France
CHU de Saint-Etienne
Saint-Etienne, France
CHU Saint-Etienne
Saint-Etienne, France
CHRU de Strasbourg
Strasbourg, France
CHU de Tours
Tours, France
CH de Valenciennes
Valenciennes, France
Related Publications (1)
Pascart T, Fautrel B, Gottenberg JE, Ducoulombier V, Richez C, Truchetet ME, Avouac J, Morel J, Basch A, Cormier G; SUNSTAR Study Group; CRI-IMIDIATE Network; Houvenagel E, Mariette X, Norberciak L. Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial. BMJ Open. 2025 Jun 17;15(6):e098298. doi: 10.1136/bmjopen-2024-098298.
PMID: 40527572DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascart Tristan, MD
GHICL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2017
First Posted
July 24, 2017
Study Start
January 22, 2018
Primary Completion
September 1, 2024
Study Completion
November 1, 2024
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share