SYF872aaa6d62f34ca6adb8c1316fb79eb8Registry ID: 2022-502021-18-00|RecruitingPhase 4
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Secondary identifiers
interventional
N/A
7 countries
14
This study will test the utility of synovial tissue biomarkers (=drug target signatures) to enrich for treatment response in RA patients failing csDMARD therapy and starting on a biologic therapy (e.g. anti-TNF, IL6 inhibitor). The specific aim of the sub-study is to discover if a biopsy at presentation prior to any RA treatment (collected as part of the 3TR-PARTNER-RA study) can be used to determine treatment response even after the patient has received cDMARDs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2023
Actual (reported)The primary endpoint of the study will be a binary outcome of treatment responder/nonresponder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks.
Percentage of patients with DAS28(ESR)<3.2 (LDA) at 12 weeks
Percentage of patients with CDAI ≤10 (LDA) at 12 weeks
Percentage of patients with CDAI remission at 12 weeks
Change in HAQ-DI at 12 weeks from baseline
Change in SF-36 at 12 weeks from baseline
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Kevzara 200 mg solution for injection in pre-filled pen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Enbrel 50 mg solution for injection in pre-filled pen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Kevzara 150 mg solution for injection in pre-filled pen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Kevzara 200 mg solution for injection in pre-filled pen
Named ingredient: sarilumab
View registry recordEnbrel 50 mg solution for injection in pre-filled pen
Named ingredient: Etanercept
View registry recordKevzara 150 mg solution for injection in pre-filled pen
Named ingredient: sarilumab
View registry recordCliniques Universitaires Saint-Luc
Sint-Lambrechts-Woluwe, 1200, Belgium
Amsterdam UMC
Amsterdam, 1105 AZ, Netherlands
Hospital De Santa Maria E.P.E.
Lisbon, 1649-028, Portugal
Joanna Peel
First Submitted
May 10, 2023
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Contact the study team to confirm eligibility.
Azienda Ospedaliera Universitaria Di Cagliari
Monserrato, 09042, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
A.O.U Maggiore della Carità
Italy
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, 00161, Italy
Humanitas Research Hospital
Rozzano, 20089, Italy
Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
Barcelona, 08036, Spain
Area Sanitaria Da Coruna E Cee
A Coruna, 15006, Spain
Hospital Universitario Reina Sofia
Cordoba, 14004, Spain
Charite Universitaetsmedizin Berlin KöR
Berlin, 10117, Germany
Universitaetsklinikum Bonn AöR
Bonn, 53127, Germany