belimumab and rituximab in subjects with primary Sjögren’s syndrome
Research type
Research Study
Full title
A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.
IRAS ID
218494
Contact name
Wan-Fai Ng
Contact email
Sponsor organisation
GlaxoSmithKline UK pharma
Eudract number
2015-000400-26
Clinicaltrials.gov Identifier
2014N220285_04, Full protocol number
Duration of Study in the UK
2 years, 9 months, 6 days
Research summary
This GSK study will test the safety and efficacy of two medicines, belimumab and rituximab, given alone or in combination in patients with primary Sjögren’s syndrome.
In Sjögren’s syndrome, excessive activity of a type of white blood cells (B-cells) is thought to cause progression of the disease. Both belimumab and rituximab work in different ways to stop B-cells. It is hoped that these drugs, given alone or in combination, may have a beneficial effect on the disease. Up to 120 people in several countries around the world will take part in this study, and around 8 in the UK.
Information about how the study drug(s) affect the subject’s body and health will be collected through a number of tests, procedures and questions. Neither the people taking part in the study (the ‘subjects’) or the study doctors and nurses will know what treatment each person will get.
Both belimumab and rituximab have been approved in many countries for the treatment of other diseases involving abnormal activity of the B-cells however it is not known how safe or how effective they are in Sjögren’s syndrome
Participation in this study will last between 16 and 24 months, depending upon the levels of B-cells in the subject’s blood.
All subjects will receive belimumab or an inactive placebo every week for 51 weeks as an injection under the skin. The injection will be self-administered and help will be given on how to do this.
All subjects will also receive rituximab or placebo on weeks 8 and 10 through a needle placed in a vein (IV infusion) which takes 3-4 hours, followed by an observation period of 1h in clinic.
All subjects will undergo a lip biopsy before the study treatment and after 24 weeks of treatment.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0020
Date of REC Opinion
17 Mar 2017
REC opinion
Further Information Favourable Opinion