A Multinational, Prospective, Observational Study of the Effectiveness, Healthcare Resource Utilization and Costs in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic or Biologic Disease‑Modifying Therapies (RA-BE-REAL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25165
• EU PAS number:
  EUPAS25164
• Study ID:
  25165
• Official title and acronym:
  A Multinational, Prospective, Observational Study of the Effectiveness, Healthcare Resource Utilization and Costs in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic or Biologic Disease‑Modifying Therapies (RA-BE-REAL)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Brazil

  Canada

  France

  Germany

  Italy

  Saudi Arabia

  Spain

  United Kingdom
• Study description:
  This is a prospective noninterventional 2-cohort study. Cohort A comprises patients with rheumatoid arthritis (RA) starting baricitinib for the first time at any point in the treatment algorithm, and Cohort B comprises patients starting treatment with any other targeted synthetic disease-modifying antirheumatic drug (tsDMARD), or a biologicaldisease-modifying antirheumatic drug (bDMARD) for the first time at any point in the treatment algorithm. The aim of the study is to define a patient profile of patients with RA starting baricitinib, other tsDMARDs, or bDMARDs for the first time, describing their patient characteristics as well as clinical and patient-reported outcomes (includinghealth related quality of life HRQOL and patient’s assessment of pain), healthcare resource utilization (HRU) and costs. The study will also describe how these treatments are used in a real-world setting by assessing treatment patterns.
• Study status:
  Planned

Research institutions and networks

Institutions

Syneos Health

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 18/01/2018

Study start date

Planned: 29/09/2018

Date of final study report

Planned: 01/07/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Company

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable