An Active Surveillance, Post Authorization Safety Study (PASS) to Investigate Relevant Safety Outcomes among Patients Treated with Flixabi for Rheumatoid Arthritis (RA) within the German Registry Rheumatoide Arthritis: Beobachtung der Biologika-Therapie (RABBIT)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001076
• Study ID:
  1000001076
• Official title and acronym:
  An Active Surveillance, Post Authorization Safety Study (PASS) to Investigate Relevant Safety Outcomes among Patients Treated with Flixabi for Rheumatoid Arthritis (RA) within the German Registry Rheumatoide Arthritis: Beobachtung der Biologika-Therapie (RABBIT)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  To investigate relevant safety outcomes in patients with rheumatoid arthritis by evaluating and comparing unadjusted incidence rates of pre-defined outcomes in patients exposed to Flixabi (index drug group) and patients treated with infliximab (biologic original and biosimilar) except Flixabi (comparator group), and estimating and comparing the risk of pre-defined outcomes in patients exposed to the index drug in comparison to patients exposed to drugs from the comparator group by applying multivariable adjusted analyses.
• Study status:
  Finalised

Research institutions and networks

Institutions

Epidemiology Unit, Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

Germany

Study timelines

Date when funding contract was signed

Planned:01/01/2023

Actual:01/01/2023

Study start date

Planned:01/01/2023

Actual:01/01/2023

Date of final study report

Planned:31/03/2026

Actual:10/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Samsung Bioepis

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)