An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis (CT-P13 4.8)

Study identification

• EU PAS number:
  EUPAS50207
• Study ID:
  103361
• Official title and acronym:
  An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis (CT-P13 4.8)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  Finland

  France

  Germany

  Italy

  United Kingdom
• Study description:
  This study is an observational, prospective cohort study to assess the safety of Remsima® Subcutaneous by evaluation of adverse events of special interest and to evaluate additional safety of Remsima® Subcutaneous in Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Psoriasis (Ps) patients. Approximately 288 male or female patients with RA will be enrolled and treated with Remsima® SC and approximately 576 male or female patients (288 patients in each treatment group of Remsima® SC and IV) with AS, PsA and Ps will be enrolled and treated with either Remsima® SC or IV. This study will be carried out according to routine practice in European region.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Celltrion

Study timelines

Date when funding contract was signed

Actual: 18/10/2022

Study start date

Planned: 02/01/2023

Actual: 13/01/2023

Data analysis start date

Planned: 31/03/2027

Date of interim report, if expected

Planned: 30/09/2025

Date of final study report

Planned: 30/09/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celltrion Inc.

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)