STRATIFY lupus
Research type
Research Study
Full title
A Phase IIIa randomised placebo-controlled biomarker enrichment trial: IgA2 anti-DNA antibodies as a biomarker of response to belimumab after rituximab in systemic lupus erythematosus.
IRAS ID
1013219
Contact name
Felicia Ikeji
Contact email
Sponsor organisation
Comprehensive Clinical Trials Unit at UCL
Research summary
People with systemic lupus erythematosus (SLE) that is not responding to usual treatments like steroids are normally prescribed rituximab. STRATIFY lupus is based on a previous trial, BEAT-lupus, which showed that participants who were treated with belimumab after rituximab had fewer severe flares (worsening of symptoms) compared to treatment with rituximab alone.
Autoantibodies are produced by the immune system in people with SLE and cause damage and inflammation to the body. Research on samples from BEAT-lupus participants identified an autoantibody called IgA2 anti-dsDNA that predicts which SLE patients may respond better to the combination treatment of rituximab followed by belimumab.
STRATIFY lupus will recruit people with active SLE who are not responding to standard treatment, are being considered for rituximab, and are positive for the IgA2 anti-dsDNA antibody. 66 participants will be recruited and randomly allocated to either group A, belimumab intravenous (IV) infusions after rituximab for 48 weeks or group B, placebo IV infusions after rituximab treatment for 48 weeks. Participants will be in the study for a total of 52 weeks. The trial is ‘double blind’ meaning neither the participant nor trial team will know which group the participant has been randomly allocated to.
Participants will attend face to face visits including an IV infusion every 2 weeks and then every 4 weeks until week 48. The final visit at week 52 does not include an IV infusion. Participants will undergo pre-specified assessments, complete questionnaires, and may have optional research blood and stool samples collected.
STRATIFY lupus is funded by Arthritis UK and the NIHR Efficacy and Mechanism Evaluation Programme (EME). The trial will be recruiting from sites across England and Wales. A positive trial will help to ensure access to rituximab followed by belimumab for those people who are most likely to respond and improve our understanding of SLE as a result.
REC name
London - Chelsea Research Ethics Committee
REC reference
26/LO/0131
Date of REC Opinion
2 Apr 2026
REC opinion
Further Information Unfavourable Opinion