MS clinical trial data

Studies Included in Efficacy Pooling Wave 1

Study Name

Protocol Number

Brief Overview of Study Design

OPERA I

WA21092

– Randomised study.  96 Weeks of Study Treatment, Followed by SFU and then OLE

– 24 Week x 4 Cycles, OCR vs Rebif (Interferon beta-1a)

– RRMS patients, primary endpoint Relapse Rate.

OPERA II

WA21093

– Randomised study.  96 Weeks of Study Treatment, Followed by SFU and then OLE

– 24 Week x 4 Cycles, OCR vs Rebif (Interferon beta-1a)

– RRMS patients, primary endpoint Relapse Rate.

ORATORIO

WA25046

– Randomised study.  120 Weeks of Study Treatment followed by possible Additional Cycles, SFU then OLE.

– 24 Week Cycles, OCR vs Placebo.

– PPMS Patients, Primary endpoint CDP.

ENSEMBLE

MA30143

– Open-Label study.  192 Weeks of Study (Last treatment at Week 168) Treatment, Followed by SFU.

– 24 Week x 8 Cycles. Open Label Ocrelizumab.

– RRM Patients, Primary endpoint various measures of CDP, CDI, EDSS, Relapse Rate

OLYMPUS

U2786G

– Randomised study.  96 Weeks of Study Treatment, Followed by SFU

– 24 Week x 4 Cycles, Rituximab vs Placebo

– PPMS Patients, Primary endpoint CDP.

CASTING

MA30005

– Open-Label study.  96 Week of Study (Last treatment at Week 72) Treatment, Followed by SFU.

– 24 Week x 4 Cycles. Open Label Ocrelizumab.

– Patients must have had a prior suboptimal response to a DMT to be included in study.

– RRM Patients, Primary endpoint the proportion of patients with NEDA (No evidence of disease activity)

CHORDS

MN30035

– Open-Label study.  96 Week of Study Treatment (Last treatment at Week 72), Followed by SFU.

– 24 Week x 4 Cycles. Open Label Ocrelizumab.

– Patients must have had a prior sub-optimal response to a DMT to be included in study.

Studies Included in Efficacy Pooling Wave 2

Study Name

Protocol Number

Brief Overview of Study Design

LIBERTO

MN39158

– Long Term Extension Study (Rollover) for patients from previous Ocrevus Studies. Currently only CASTING patients are included, more studies to be added in future.  Liberto data will be moved to Casting to make 1 study in Efficacy Pooling.

– 24 Week x 3 Cycles. Open Label Ocrelizumab.

OBOE

ML29966

– Exploratory Biomarker Study for patients with RMS and PPMS.

– Open Label Study with 4 RMS cohorts and 1 PPMS cohort with different treatment schedules over 1 year.

PHASE 2

WA21493

– Phase II study. RMS patients.

– Randomised study of OCR (600mg and 1000mg) vs Placebo/Avonex

– Primary endpoint:  Number of T1 Lesions.   Secondary Endpoints:  Relapse Rate, T2 lesions. Dose Finding and PK.

CONSONANCE

MN39159

– Open-Label study.  192 Weeks of Study (Last treatment at Week 168) Treatment, Followed by SFU.

– 24 Week x 8 Cycles. Open Label Ocrelizumab.

– PMS Patients, Primary endpoint: NEP and NEPAD.  

HERMES

U2787G

– Phase II Randomised study.  48 Weeks of Study Treatment, Followed by SFU

– 24 Week x 2 Cycles, Rituximab vs Placebo

– RRMS Patients, Primary endpoint Number of T1 Lesions.