Synergetic B-cell Immunomodulation in SLE - 2nd Study.

Summary

In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment with belimumab (anti-BAFF) followed by rituximab(anti-CD20) in lupus nephritis patients.

Timeline

Start

2018-10-01

Primary completion

2024-06-07

Completion

2026-06-07

Publications

• Arends EJ, Zlei M, Tipton CM, Cotic J, Osmani Z, de Bie FJ, Kamerling SWA, van Maurik A, Dimelow R, Gregan YI, Fox NL, Rabelink TJ, Roth DA, Sanz I, van Dongen JJM, van Kooten C, Teng YKO. Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2024 Sep 1;63(9):2387-2398. doi: 10.1093/rheumatology/keae286.
• van Schaik M, Arends EJ, Soonawala D, van Ommen E, de Leeuw K, Limper M, van Paassen P, Huizinga TWJ, Toes REM, van Kooten C, Rotmans JI, Rabelink TJ, Teng YKO. Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial. Trials. 2022 Nov 12;23(1):939. doi: 10.1186/s13063-022-06874-w.

Drugs

Indications