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Monoclonal Antibodies
Ocrelizumab for Multiple Sclerosis (O'HAND Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline
Neurological stability for ≥ 30 days prior to baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 8.5 years
Awards & highlights
O'HAND Trial Summary
This trial will compare the effects of a new drug, ocrelizumab, to a placebo in people with primary progressive multiple sclerosis. The study will focus on how much disability progresses.
Who is the study for?
Adults with primary progressive multiple sclerosis (PPMS) who have an EDSS score of 3.0 to 8.0, a documented history of certain laboratory findings in cerebrospinal fluid, and disease duration requirements based on their EDSS score. Women must be non-reproductive or agree to contraception. Exclusions include other forms of MS, serious infections like PML, active malignancy, immunocompromised state, recent live vaccines, inability to complete MRI scans, drug abuse history, previous B-cell therapy or stem cell transplants.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Ocrelizumab compared to a placebo in slowing disability progression in PPMS patients. It includes screening phase followed by double-blind treatment where neither participants nor researchers know who gets the real drug or placebo; then follow-up phases and optional open-label extension where everyone receives Ocrelizumab.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions (like fever or chills), increase risk for infections due to immune system suppression, potential liver issues indicated by blood tests changes and possibly other side effects not listed here as it's being studied for its full range of effects.
O'HAND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can complete a hand dexterity test in less than 4 minutes with each hand.
Select...
My neurological condition has been stable for at least 30 days.
O'HAND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 8.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 8.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Upper Limb Disability Progression Confirmed For at Least 12 Weeks
Secondary outcome measures
Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab
B-Lymphocytes
Percent Change in Total Brain Volume on MRI Scans
+6 moreO'HAND Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OcrelizumabExperimental Treatment1 Intervention
Participants will receive ocrelizumab by IV infusion every 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
FDA approved
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,068 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,029 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,940 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,356 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have specific abnormal results in a test of the fluid around your brain and spinal cord.I have been treated with B-cell targeting therapies before.I have a history of immune system problems.My condition is relapsing-remitting or secondary progressive MS.I have been diagnosed with a neurological disorder.I have had an organ transplant or received anti-rejection medication.I have not taken systemic corticosteroids in the last 4 weeks.I do not need long-term steroids or immunosuppressants.You have a history of alcohol or drug abuse.You have no usable veins for getting medicine through a tube in your arm.You have a positive pregnancy test.I have stopped my immunotherapy treatment for the required time.I meet all specific requirements for using Ocrevus as per my local guidelines.My MS symptoms started less than 10, 15, or 20 years ago, depending on my current disability level.I have had a bone marrow or stem cell transplant.My immune system is weakened.Your EDSS score at screening and baseline is between 3.0 and 8.0.You cannot have an MRI scan or cannot have a dye called Gd.I haven't taken any experimental drugs or had experimental treatments for MS in the last 24 weeks.You take longer than 25 seconds to complete a hand movement test.I do not have any major uncontrolled health issues that would stop me from joining the study.I have not received a live vaccine in the last 6 weeks.I have a serious infection like TB or a fungal infection.I have or might have had a brain infection called PML.I am currently being treated or monitored for cancer recurrence.You need to have signs of activity on your MRI, such as specific types of lesions, to be eligible for the study if a certain number of patients without MRI activity have already been enrolled.You have tested positive for hepatitis B during screening.I don't have uncontrolled psychosis or closed-angle glaucoma.I am a woman who cannot become pregnant because I am either surgically sterile or post-menopausal.I am not starting new MS treatments or physiotherapy within the next 4 weeks.I have not had IV Ig or plasmapheresis in the last 12 weeks.I can complete a hand dexterity test in less than 4 minutes with each hand.My neurological condition has been stable for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Ocrelizumab
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA's most recent opinion on Ocrelizumab?
"Ocrelizumab has undergone Phase 3 trials, so there is some evidence of its efficacy as well as data from multiple rounds of safety testing. Therefore, it receives a score of 3."
Answered by AI
For this test, are elderly patients being recruited?
"This trial's requirements for eligible participants are that they are between 18-65 years old. Out of the 458 total trials, 44 are for minors and 414 are for elderly patients."
Answered by AI
Is this study accessible to many people in Canada?
"Patients are currently being accepted at over 30 different locations around the United States of America, including Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology in Houston, Texas, Multiple sclerosis Center of California in Newport Beach, California, and Henry Ford Hospital in Detroit, Michigan."
Answered by AI
Could you please list other scientific research studies that have used Ocrelizumab?
"Ocrelizumab was first introduced in 2008 in a Legacy Health System clinical trial. Out of the 18276 completed studies, 29 are still ongoing; many of which are based in Houston, Texas."
Answered by AI
Which patients does this study require?
"This study is only admitting around 1000 people, who must have primary progressive multiple sclerosis and be aged between 18 and 65."
Answered by AI
Is this research study new and innovative?
"As of now, 29 clinical trials involving Ocrelizumab are ongoing in 321 cities and 60 different nations. The first study of its kind was sponsored by Roche Pharma AG and completed its Phase 2 drug approval stage in 2008. It involved 220 patients. In the years since 2008, a total of 18276 trials have been conducted."
Answered by AI
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