An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis(AS)

Study identification

• EU PAS number:
  EUPAS9491
• Study ID:
  28172
• Official title and acronym:
  An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis(AS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  France

  Germany

  Korea, Republic of
• Study description:
  The primary objective of this study is to assess the safety of RemsimaTM in ankylosingspondylitis (AS) patients, in comparison with patients receiving other anti-TNF drugs, by evaluation ofevents of special interest (ESI) for up to 5 years from the first visit of each patient.The secondary objectives of this study are to evaluate efficacy and additional safety of RemsimaTM in ASpatients, in comparison with patients receiving other TNF blockers. Health-economics parameters will alsobe assessed.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Revmatologicky ustav

Study timelines

Date when funding contract was signed

Actual:14/01/2015

Study start date

Actual:26/05/2015

Data analysis start date

Planned:21/01/2016

Date of interim report, if expected

Planned:31/05/2016

Date of final study report

Planned:31/12/2026

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)