Trial Will Test Ocrevus on Arm, Hand Function in PPMS
The trial, called O’HAND (NCT04035005), expects to enroll approximately 1,000 adults with PPMS, ages 18 to 65, at more than 200 sites around the world. A full list of study sites and contact information is available here.
Ocrevus, marketed by Genentech (part of the Roche Group), works by killing immune cells called B-cells, thereby limiting inflammation that damages the nervous system in MS. It was the first therapy to be approved to treat PPMS in the U.S. and the European Union; to date, it remains the only approved therapy for PPMS. Ocrevus also is approved to treat relapsing types of MS.
Approvals of the therapy for PPMS were based on clinical trial data that showed Ocrevus reduced disease progression, using the Expanded Disability Status Scale (EDSS), a physical and neurological exam used to assess vision, coordination, limb movement, strength, thinking abilities, bowel and bladder control, sensation, and walking ability.
The new clinical trial, sponsored by Roche, intends to specifically evaluate the effect of treatment on the function of the upper limbs (that is, the arms and hands).
“Having the use of the upper limbs can make the difference between remaining independent and requiring substantial daily help from others,” according to a press release from the National MS Society. The society offers a brochure for MS patients who are considering enrolling in clinical trials.
Of note, O’HAND is open to participants with EDSS scores ranging from 3.0 – indicating limited moderate or some mild disability, without trouble walking – to 8.0, meaning patients are confined to bed or a wheelchair, but with generally effective use of their arms.
After a screening period lasting up to six months, participants in the trial will be randomly given either Ocrevus or a placebo, administered by infusion directly into the bloodstream every 24 weeks for at least 120 weeks (more than two years).
Participants who discontinue from this phase of the trial will be enrolled in a separate phase for follow-up evaluation. If results from the trial’s primary analysis are positive, additional trial phases are planned to continue studying the long-term effects of treatment.
The trial’s primary endpoint – its main measurement of efficacy – is how long it takes for participants to have confirmed worsening of upper limb disability, lasting at least 12 weeks.
Upper limb function will be measured with a standard assessment called the Nine-Hole Peg Test, which involves timing how long it takes for a person to put pegs into holes on a board, then remove the pegs. Other measures of disability progression, disease activity, and safety outcomes also will be assessed.
Top-line data from the trial is expected by 2025, and its completion is anticipated for April 2028.