An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis

Study identification

• EU PAS number:
  EUPAS8571
• Study ID:
  28166
• Official title and acronym:
  An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Korea, Republic of

  Romania

  Spain
• Study description:
  The objective of this study is to assess the long-term safety and efficacy of RemsimaTM in Rheumatoid Arthritis (RA) patients.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Sf.Maria Clinical Hospital

Study timelines

Date when funding contract was signed

Actual: 11/12/2014

Study start date

Planned: 30/09/2015

Actual: 30/09/2015

Data analysis start date

Planned: 31/01/2016

Date of interim report, if expected

Planned: 31/05/2016

Date of final study report

Planned: 30/10/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celltrion

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)