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.
- Multiple Sclerosis
- Radiologically Isolated Syndrome
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Up 4 years
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Ocrelizumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
100 Total Participants · 2 Treatment Groups
Primary Treatment: Ocrelizumab · Has Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 40 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| The Elliot Lewis Center for Multiple Sclerosis Care | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- Longbrake, Erin E., Le H. Hua, Ellen M. Mowry, Susan A. Gauthier, Enrique Alvarez, Anne H. Cross, Jinglan Pei, et al.. 2022. “The CELLO Trial: Protocol of a Planned Phase 4 Study to Assess the Efficacy of Ocrelizumab in Patients with Radiologically Isolated Syndrome”. Multiple Sclerosis and Related Disorders. Elsevier BV. doi:10.1016/j.msard.2022.104143.
- Longbrake EE, Hua LH, Mowry EM, Gauthier SA, Alvarez E, Cross AH, Pei J, Priest J, Raposo C, Hafler DA, Winger RC. The CELLO trial: Protocol of a planned phase 4 study to assess the efficacy of Ocrelizumab in patients with radiologically isolated syndrome. Mult Scler Relat Disord. 2022 Aug 22;68:104143. doi: 10.1016/j.msard.2022.104143. Online ahead of print.
- Longbrake EE, Hua LH, Mowry EM, Gauthier SA, Alvarez E, Cross AH, Pei J, Priest J, Raposo C, Hafler DA, Winger RC. The CELLO trial: Protocol of a planned phase 4 study to assess the efficacy of Ocrelizumab in patients with radiologically isolated syndrome. Mult Scler Relat Disord. 2022 Dec;68:104143. doi: 10.1016/j.msard.2022.104143. Epub 2022 Aug 22.
- Erin E Longbrake 2022. "Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04877457.
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
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
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
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
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
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
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
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