SABLE: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without Benlysta (Belimumab) (116543)

Study identification

• EU PAS number:
  EUPAS4966
• Study ID:
  45713
• Official title and acronym:
  SABLE: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without Benlysta (Belimumab) (116543)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Austria

  Belgium

  Canada

  France

  Germany

  Israel

  Italy

  Portugal

  Slovakia

  Spain

  Sweden

  United States
• Study description:
  No information provided.
• Study status:
  Finalised

Research institutions and networks

Institutions

Quintiles

Study timelines

Date when funding contract was signed

Planned:31/10/2012

Actual:31/10/2012

Study start date

Planned:21/02/2013

Actual:21/02/2013

Date of final study report

Planned:08/09/2025

Actual:05/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)