NCT02631538 - Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 17, 2016

Primary Completion Date

June 23, 2020

Study Completion Date

June 23, 2020

Conditions

Sjogren's Syndrome

Interventions

DRUG

Belimumab

Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.

DRUG

Rituximab

Rituximab will be provided as a 100 mg concentrated solution for infusion. It is a clear, colorless liquid.

DRUG

Placebo belimumab

The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.

DRUG

Placebo rituximab

Placebo rituximab will be provided as solution for infusion. It is a clear, colorless liquid.

Trial Locations (36)

5000

GSK Investigational Site, Córdoba

10117

GSK Investigational Site, Berlin

22763

GSK Investigational Site, Hamburg

25123

GSK Investigational Site, Brescia

28041

GSK Investigational Site, Madrid

28050

GSK Investigational Site, Madrid

33000

GSK Investigational Site, Bordeaux

33100

GSK Investigational Site, Udine

35128

GSK Investigational Site, Padua

55131

GSK Investigational Site, Mainz

56126

GSK Investigational Site, Pisa

59037

GSK Investigational Site, Lille

67098

GSK Investigational Site, Strasbourg