NCT03227419CompletedPhase 4
ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TARGETED TREATMENT INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPENLABELED, SUPERIORITY TRIAL. -SUNSTAR-
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jul 2024
Brief summary (registry, in English)
Compare tocilizumab versus abatacep administered subcutaneously efficacy in inadequate responder patients to one or two targeted treaments.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 224 (actual)
- First submitted
- 10 Jul 2024
- Start date
- 23 Jan 2018
- Lead sponsor
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03227419
- EU CT number
- 2024-515600-39-00
- EudraCT number
- 2017-000947-41
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 224
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior treatment by tocilizumab, sarilumab or abatacept
- Prior treatments accepted are TNF alpha inhibitor, rituximab and jak inhibitors
Other illness
- failure to a first or second line of targeted treatment
Other
- breastfeeding woman
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Completed |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Hospitalier de Boulogne-Sur-Mer Coordinator of this site? Confirm its status | Boulogne-sur-Mer | France | Completed |
| Centre Hospitalier Jean Rougier Coordinator of this site? Confirm its status | Cahors | France | Completed |
| Clinique De L'infirmerie Protestante De Lyon Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Completed |
| Hôpital NOVO - Site de Pontoise Coordinator of this site? Confirm its status | Cergy Pontoise | France | Completed |
| CHRU de Tours - Hôpital Trousseau Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Completed |
| CHU Clermont Ferrand -Site Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Completed |
| Hôpital Bicêtre APHP Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Completed |
| CHU De Lille, Hôpital Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Completed |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lomme Cedex | France | Completed |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire d'Orléans Coordinator of this site? Confirm its status | ORLEANS | France | Completed |
| Hôpital Lariboisière APHP Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hopital Bichat - Claude Bernard - AP-HP Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux de Paris – Hopital Cochin Coordinator of this site? Confirm its status | Paris | France | Completed |
| APHP - Hôpital Universitaire Pitié-Salpêtrière Coordinator of this site? Confirm its status | PARIS | France | Completed |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| CHU Reims Hôpital Maison Blanche Coordinator of this site? Confirm its status | Reims | France | Completed |
| CHU de Rouen - Hôpital de Bois Guillaume Coordinator of this site? Confirm its status | ROUEN | France | Completed |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Centre Hospitalier de Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Completed |
| CHRU de Nancy - Hôpitaux de Brabois Coordinator of this site? Confirm its status | Vandoeuvre-les-Nancy | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.