Protocol Title : A Randomised, open labelled study in anti ... - EME

!
5. Kramm H, Hansen KE, Gowing E, Bridges A. Successful therapy of rheumatoid arthritis with
rituximab: renewed interest in the role of B cells in the pathogenesis of rheumatoid arthritis. J
Clin Rheumatol 2004;10:28-32.
6. Rubbert-Roth A, Tak PP, Zerbini C, et al. Efficacy and safety of various repeat treatment
dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III
randomized study (MIRROR). Rheumatology (Oxford, England) 2010;49:1683-93.
7. Khan A, Scott D. Rituximab after methotrexate failure in rheumatoid arthritis: evaluation of the
SERENE trial. Expert Opin Biol Ther 2011;11:1515-8.
8. Dass S, Rawstron AC, Vital EM, Henshaw K, McGonagle D, Emery P. Highly sensitive B cell
analysis predicts response to rituximab therapy in rheumatoid arthritis. Arthritis and
rheumatism 2008;58:2993-9.
9. Leandro MJ, Cambridge G, Ehrenstein MR, Edwards JC. Reconstitution of peripheral blood B
cells after depletion with rituximab in patients with rheumatoid arthritis. Arthritis and
rheumatism 2006;54:613-20.
10. Thurlings RM, Vos K, Wijbrandts CA, Zwinderman AH, Gerlag DM, Tak PP. Synovial tissue
response to rituximab: mechanism of action and identification of biomarkers of response.
Annals of the rheumatic diseases 2008;67:917-25.
11. Taylor PC. Antibody therapy for rheumatoid arthritis. Curr Opin Pharmacol 2003;3:323-8.
12. Buch MH, Smolen JS, Betteridge N, et al. Updated consensus statement on the use of
rituximab in patients with rheumatoid arthritis. Annals of the rheumatic diseases
2011;70:909-20.
13. Boumans MJ, Vos K, Gerlag DM, Tak PP. Biological treatment of rheumatoid arthritis: towards
a more cost-effective re-treatment regimen using rituximab? Annals of the rheumatic diseases
2011.
14. Humby F, Bombardieri M, Manzo A, et al. Ectopic lymphoid structures support ongoing
production of class-switched autoantibodies in rheumatoid synovium. PLoS medicine
2009;6:e1.
15. Vos K, Thurlings RM, Wijbrandts CA, van Schaardenburg D, Gerlag DM, Tak PP. Early effects
of rituximab on the synovial cell infiltrate in patients with rheumatoid arthritis. Arthritis and
rheumatism 2007;56:772-8.
16. Lindberg J, af Klint E, Catrina AI, et al. Effect of infliximab on mRNA expression profiles in
synovial tissue of rheumatoid arthritis patients. Arthritis research & therapy 2006;8:R179.
17. Wijbrandts CA, Dijkgraaf MG, Kraan MC, et al. The clinical response to infliximab in
rheumatoid arthritis is in part dependent on pretreatment tumour necrosis factor alpha
expression in the synovium. Annals of the rheumatic diseases 2008;67:1139-44.
18. Haupl T, Stuhlmuller B, Grutzkau A, Radbruch A, Burmester GR. Does gene expression
analysis inform us in rheumatoid arthritis? Annals of the rheumatic diseases 2010;69 Suppl
1:i37-42.
19. van Baarsen LG, Wijbrandts CA, Gerlag DM, et al. Pharmacogenomics of infliximab treatment
using peripheral blood cells of patients with rheumatoid arthritis. Genes Immun 2010;11:622-9.
20. Kaufmann M, Pusztai L. Use of standard markers and incorporation of molecular markers into
breast cancer therapy: Consensus recommendations from an International Expert Panel.
Cancer 2011;117:1575-82.
Study: R4RA EudraCT: 2012-002535-28 36 / 34