Ocrelizumab for Multiple Sclerosis

University of South Florida Morsani Center, Tampa, FL
Multiple Sclerosis+1 More ConditionsOcrelizumab - Drug
18 - 40
All Sexes

Study Summary

This trial is testing if ocrelizumab can prevent or delay the onset of full-blown multiple sclerosis in people who have signs of the disease but have not yet developed symptoms.

Eligible Conditions
  • Multiple Sclerosis
  • Radiologically Isolated Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up 4 years

Week 208
Change in serum NfL (sNfL)
Week 208
Change in T2-lesion volume
Change in total brain volume
Change in total spinal cord volume
Up 4 years
Time to development of first new radiologic or clinical evidence of MS
Up to 4 years
Cumulative number of new T1 gadolinium-enhancing lesions
Cumulative number of new or enlarging T2 lesions

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

31%Infusion related reaction
14%Upper respiratory tract infection
13%Urinary tract infection
6%Back pain
4%Influenza like illness
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT01247324) in the Ocrelizumab ARM group. Side effects include: Infusion related reaction with 31%, Upper respiratory tract infection with 14%, Urinary tract infection with 13%, Nasopharyngitis with 11%, Headache with 8%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Ocrelizumab · Has Placebo Group · Phase 4

Experimental Group · 1 Intervention: Ocrelizumab · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up 4 years

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,728 Previous Clinical Trials
20,525,476 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
1,743 Patients Enrolled for Multiple Sclerosis
Genentech, Inc.Industry Sponsor
1,513 Previous Clinical Trials
568,176 Total Patients Enrolled
24 Trials studying Multiple Sclerosis
3,314 Patients Enrolled for Multiple Sclerosis

Eligibility Criteria

Age 18 - 40 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This refers to the process of checking if you meet the requirements to participate in the clinical trial.
Participants will be randomly assigned to different groups.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
The Elliot Lewis Center for Multiple Sclerosis Care100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Is this trial targeting individuals of a certain age demographic?

"This medical trial has specified an age range of 18 to 40 as the inclusion criteria. There are 417 trials that cater to patients younger than 18, and 1379 for individuals above 65 years old." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor currently recruiting participants?

"Per the information found on clinicaltrials.gov, this trial is recruiting participants as previously reported. The first post was made in mid-February of 2022 with a subsequent update at the end of October." - Anonymous Online Contributor

Unverified Answer

Who meets the criteria to partake in this research endeavor?

"This clinical trial seeks 100 individuals between 18 and 40 years of age that have been diagnosed with multiple sclerosis. Specifically, applicants must meet the following criteria: be related to an individual who has clinically definite MS, possess established RIS diagnosis (CNS lesions consistent with McDonald 2017 criteria for DIS) within 5 years or known previous accumulation of CNS lesion in this time frame, no prior long-term immunomodulatory medication exposure, signed informed consent form, ability to comply with study protocol and provide written informed consent as well as present CNS lesions meeting McDonald 2017 criteria for DIS and serologic workup negating alternative diagnoses." - Anonymous Online Contributor

Unverified Answer

How many physical sites are involved in the execution of this experiment?

"This medical research is being conducted in a range of locations, including Icahn School of Medicine at Mount Sinai (New York), University of Utah (Salt Lake City) and Georgetown University (Washington D.C.). Additionally, there are 14 other trial sites involved." - Anonymous Online Contributor

Unverified Answer

Has the FDA provided authorization for Ocrelizumab to be utilized?

"Through careful evaluation, our Power team has declared Ocrelizumab to be a 3 on the safety scale. This is because this therapy is already approved and in Phase 4 trials." - Anonymous Online Contributor

Unverified Answer

Is this scientific research a pioneering endeavor?

"Presently, 29 clinical investigations involving Ocrelizumab are in progress across 321 cities and 60 countries. This drug was initially trialled by Genentech Inc back in 2008 with 220 participants during its Phase 2 approval process. Subsequent studies have totaled 18340 to date." - Anonymous Online Contributor

Unverified Answer

To what extent has the patient population engaged in this clinical trial?

"To execute the study, 100 suitable participants are needed. Genentech Inc., who is sponsoring this trial, will be conducting it in various sites such as Icahn School of Medicine at Mount Sinai (New York City) and University of Utah (Salt Lake City)." - Anonymous Online Contributor

Unverified Answer

To what extent has Ocrelizumab been studied in clinical research?

"Ocrelizumab was initially studied in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge and has since been the subject of 18340 completed clinical trials. Currently, there are 29 active trials taking place across various locations with a high concentration being conducted out of New York City." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.