Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea (REMSIMA_PMS)

Study identification

• EU PAS number:
  EUPAS10911
• Study ID:
  28448
• Official title and acronym:
  Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea (REMSIMA_PMS)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  This surveillance is conducted for a period of four years from the approval date (July 20, 2012), at six-month intervals for the first two years and one-year intervals for the subsequent two years, as part of a marketing authorisation conditions in Republic of Korea, where the efficacy and safety of the approved medicinal product are closely monitored under the 're-examination period'.The objectives of this post-marketing surveillance (PMS) are to evaluate the safety and efficacy of REMSIMA in Korea under routine care and identify the issues regarding the following: (1) Serious adverse events (SAEs) and adverse drug reactions (ADRs). SAE or ADR is considered as such if it: (a) results in death or is life-threatening, (b) requires inpatient hospitalization or prolongation of existing hospitalization,(c) causes a persistent or significant disability/incapacity, (d) results in a congenital anomaly/birth defect, or (e) is associated with any other medically important condition. (2) Unexpected adverse events and adverse drug reactions that are not reflected in the directions for the use of drug(3) Already known adverse drug reactions(4) Non-serious adverse events (5) Other information about safety and efficacy
• Study status:
  Finalised

Research institutions and networks

Institutions

Celltrion

Multiple centres: 39 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 20/07/2012

Study start date

Actual: 23/01/2013

Data analysis start date

Actual: 20/07/2012

Date of final study report

Actual: 19/07/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celltrion Inc.

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)