CASTING
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
Results by group
Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
Week 96
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ocrelizumab | 74.8 Percentage of Participants | 71.3–78 | 658 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ocrelizumab | 680 | 49 (7.2%) | 1 |
| Ocrelizumab Safety Follow-up | 64 | 6 (9.4%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
Week 96
Disability progressionRelapsesMRI lesions1. Proportion of patients who have no evidence of disease activity (NEDA), as per protocol defined events over 96-weeks (with MRI baseline at Week 8)
MRI lesions
Other measures (27)
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
Baseline up to 24 weeks
Disability progressionRelapsesMRI lesionsPercentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
Baseline up to 48 weeks
Disability progressionRelapsesMRI lesionsTime to First Protocol-Defined Event of Disease Activity
Baseline up to 96 Weeks
Disability progressionRelapsesMRI lesionsFatigueChange From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
Baseline, Weeks: 24, 48, 72, 96
Disability progressionAbsolute Change From Baseline in EDSS Category at Week 96
Up to Week 96
Disability progressionPercentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96
Week 96
Disability progressionAnnualized Protocol-defined Relapse Rate at Week 96
Week 96
RelapsesTime to Onset of 24-week Confirmed Disability Progression
Baseline up to 96 Weeks
Disability progressionTime to Onset of First Protocol-Defined Relapse
Baseline up to 96 Weeks
Disability progressionRelapsesFatigueSafetyTime to Onset of First New and/or Enlarging T2 Lesion
Baseline up to 96 Weeks
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: * Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria * Have a length of disease duration, from first symptom, of less than (\<) 10 years * Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy * Suboptimal disease control while on a DMT * Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening * For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug Exclusion Criteria: * Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS) * Inability to complete an Magnetic Resonance Imaging (MRI) procedure * Known presence of other neurological disorders * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * History or currently active primary or secondary immunodeficiency * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * History of opportunistic infections * History or known presence of recurrent or chronic infection * History of malignancy * Congestive heart failure * Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
Papers
Results
Long-Term Treatment With Ocrelizumab in Patients With Early-Stage Relapsing MS: Nine-Year Data From the OPERA Studies Open-Label Extension.Neurology · 2025
Results
Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with suboptimal response to prior disease-modifying therapies: A primary analysis from the phase 3b CASTING single-arm, open-label trial.Eur J Neurol · 2022
Results
Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous disease-modifying therapy: A nonrandomized controlled trial.Mult Scler · 2022
Results
Onset of clinical and MRI efficacy of ocrelizumab in relapsing multiple sclerosis.Neurology · 2019
Results
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/
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History
Started
Sept 2016
Main results due
Oct 2019
Finished
Dec 2020
Results posted
Feb 2021
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