ORATORIO HAND
Research type
Research Study
Full title
A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
IRAS ID
263484
Contact name
Gavin Giovannoni
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2018-001511-73
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
100,593, IND
Duration of Study in the UK
7 years, 6 months, 1 days
Research summary
A Phase IIIb, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate efficacy on upper limb function and safety of ocrelizumab infusions every 24 weeks in patients with Primary Progressive MS (PPMS).
PPMS is rarer form of Multiple Sclerosis that is characterised by steady worsening of MS symptoms. Unlike the more common form relapsing-remitting MS, patients with PPMS rarely experience worsening or new MS symptoms accompanied by recovery to some degree.
Ocrelizumab is a protein that binds to the CD20 protein. CD20 is located on the surface of some B-cells. B-cells are white blood cells that help fight off infection but may also play a role in autoimmune diseases like MS. By binding to B-cells with CD20, ocrelizumab causes these cells to deplete with the aim of protecting the body from self-attacking B-cells.
Previous studies suggest that ocrelizumab could slow the progression of upper limb disability. Upper limb function is critical for patients with lower limb disability.
Approximately 1000 participants will be recruited globally, with a 1:1 randomisation of ocrelizumab and placebo. This study will recruit 2 patient types: patients with MS disease activity that is detectable by MRI and those without.
Study Phases: Screening, Double-blind treatment, Follow-up 1, Open-label extension, Follow-up 2, B-cell monitoring.
The double-blind treatment phase lasts for a minimum of 120 weeks until there are approximately 362 events of upper-limb disability progression. Upper limb disability progression is defined as a pre-specified worsening in upper limb function, maintained for at least 12 weeks.
On completion of the double-blind treatment phase, patients have the option of entering an open-label phase where all patients receive ocrelizumab.
Study length: approximately 8.5 years.
Study procedures: physical & neurological examinations, questionnaires, brain MRI’s, blood and urine tests, assessments of upper and lower limb disability.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0290
Date of REC Opinion
23 Dec 2019
REC opinion
Further Information Favourable Opinion