Severe Gout Registry (SGR)

Study identification

• EU PAS number:
  EUPAS9073
• Study ID:
  9074
• Official title and acronym:
  Severe Gout Registry (SGR)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  The Dutch Society for Rheumatology (study group gout) has writtenand confirmed a guideline on good clinical use of canakinumab. In this guideline the registration of all gout patients prescribed canakinumab is advocated, including follow up on clinical outcomes, patient reported outcomes, safety and costs. The objective of this study is to characterize the users, use and safety profile of canakinumab in the goutyarthritis population in the Netherlands and to mirror these results against a standard of care cohort of patients with frequent gout flares, not receiving canakinumab. The study will be a non-interventional, parallel-cohort, long-term safety study among gout patients experiencing frequent flares (≥ 3 yearly).
• Study status:
  Planned

Research institutions and networks

Institutions

DREAM-RA

Study timelines

Date when funding contract was signed

Planned:17/12/2014

Actual:17/12/2014

Study start date

Planned:01/01/2015

Date of final study report

Planned:31/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Regulatory

• Was the study required by a regulatory body?:
  No