Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Summary

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

Timeline

Start

2017-03-24

Primary completion

2023-04-27

Completion

2023-04-27

Publications

• Vermersch P, Benedict RHB, Van Wijmeersch B, Cutter G, Kister L, Oreja-Guevara C, Siva A, Wiendl H, Wuerfel J, El Azzouzi B, Kuenzel T, Buffels R, Craveiro L, Dirks P, Comi G. Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial. Eur J Neurol. 2026 Jun;33(6):e70628. doi: 10.1111/ene.70628.
• Garcia A, Rodriguez S, Dugast E, Lebrun-Frenay C, Thouvenot E, de Seze J, Le Page E, Vukusic S, Doghri I, Berger E, Casez O, Labauge P, Ruet A, Raposo C, Le Frere F, Nicot AB, Wiertlewski S, Gourraud PA, Michel L, Berthelot L, Laplaud DA. Durable B-Cell Impairment While Sparing IgA B Cells After Ocrelizumab Therapy in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Nov;12(11):2271-2285. doi: 10.1002/acn3.70135. Epub 2025 Aug 8.
• Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8.
• Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.
• Hartung HP, Benedict RHB, Berger T, Bermel RA, Brochet B, Carroll WM, Freedman MS, Holmoy T, Karabudak R, Nos C, Patti F, Perrin Ross A, Vanopdenbosch L, Vollmer T, Wuerfel J, Clinch S, Kadner K, Kuenzel T, Kulyk I, Raposo C, Thanei GA, Killestein J. Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis: The Phase IIIb ENSEMBLE 4-Year, Single-Arm, Open-Label Trial. Neurology. 2024 Dec 24;103(12):e210049. doi: 10.1212/WNL.0000000000210049. Epub 2024 Dec 3.
• Hartung HP, Berger T, Bermel RA, Brochet B, Carroll WM, Holmoy T, Karabudak R, Killestein J, Nos C, Patti F, Perrin Ross A, Vanopdenbosch L, Vollmer T, Buffels R, Garas M, Kadner K, Manfrini M, Wang Q, Freedman MS. ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial. J Neurol. 2024 Jul;271(7):4348-4360. doi: 10.1007/s00415-024-12326-z. Epub 2024 Apr 22.
• Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.

Drugs

Indications