Study identification

PURI

https://redirect.ema.europa.eu/resource/43383

EU PAS number

EUPAS28777

Study ID

43383

Official title and acronym

Multicenter Observational study to evaluate the effectiveness of a biosimilar Etanercept (ErelziTM) in patients with established Rheumatic disease previously treated with reference etanercept. (BRONZE)

DARWIN EU® study

No

Study countries

France

Study description

Study design: National, Multicenter, Prospective, Post-Authorization, non-PASS, Real Life, Observational Study. Primary objective: To evaluate effectiveness of ErelziTM in patients with RA, AS or PsA with, stable clinical response to Enbrel®.
Secondary objectives:
• To assess safety in a real-life situation of switching from Enbrel® to ErelziTM.
• To characterize the patient populations and drug utilization patterns of RA, AS and PsA patients who are switched to ErelziTM from stable treatment with Enbrel.
• To assess patient satisfaction at baseline and after switching to ErelziTM.
• To explore what are the factors related (clinical, diagnostic factors, comorbidities, patient therapy history, experience/expertise with biologics, patient-oriented program, clinic location, extent of physician’s knowledge of biosimilars) to the physician decision to switch.

Study status

Finalised
Research institutions and networks

Institutions

Sandoz
First published:
01/02/2024
Institution

Contact details

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Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

SANDOZ FR
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable