Post Authorization Safety Study (PASS) among Patients Treated with Flixabi for Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Other Spondyloarthropathies (SpA), and Psoriatic Arthritis (PsA) within the Swedish, Population based, Anti-Rheumatic Therapies in Sweden (ARTIS) register. (Safety of Flixabi in ARTIS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001077
• Study ID:
  1000001077
• Official title and acronym:
  Post Authorization Safety Study (PASS) among Patients Treated with Flixabi for Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Other Spondyloarthropathies (SpA), and Psoriatic Arthritis (PsA) within the Swedish, Population based, Anti-Rheumatic Therapies in Sweden (ARTIS) register. (Safety of Flixabi in ARTIS)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  To provide an assessment of pre-specified safety outcomes for Flixabi as used in the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS) and other spondyloarthropathies (SpA), and psoriatic arthritis (PsA) in Sweden, using data from the Anti-Rheumatic Therapies In Sweden (ARTIS) system.;
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Sweden

Study timelines

Date when funding contract was signed

Planned:04/01/2016

Actual:04/01/2016

Study start date

Planned:01/01/2019

Actual:01/01/2019

Date of final study report

Planned:01/01/2026

Actual:01/01/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Samsung Bioepis Co., Ltd

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)