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

• PURI:
  https://redirect.ema.europa.eu/resource/45713
• 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 status:
  Ongoing

Research institution 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: 11/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

BEL116543 (hgs1006-c1124-01)

Updated protocol

gsk-116543-protocol-amend4-redact

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)