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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to approximately 6.5 years
Awards & highlights

Study Summary

This trial is testing a new drug, ocrelizumab, on people with RMS or PPMS. The trial will last for 4.5 years, and participants will be given infusions of the drug every few weeks. The trial will test the effects of the drug on the participants' symptoms and on their biomarkers.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to approximately 6.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 6.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Other outcome measures
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Change in Levels of NfL in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
Change in Number of CD19+ B cells in CSF from Treatment Baseline to Post-Treatment with Ocrelizumab
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: RMS Cohort Arm 4: Ocrelizumab + LPExperimental Treatment4 Interventions
Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group II: RMS Cohort Arm 3: Ocrelizumab + LPExperimental Treatment4 Interventions
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group III: RMS Cohort Arm 2: Ocrelizumab + LPExperimental Treatment4 Interventions
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group IV: RMS Cohort Arm 1: Ocrelizumab + LPExperimental Treatment4 Interventions
Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
Group V: PPMS Cohort: Ocrelizumab + LPExperimental Treatment4 Interventions
For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methyloprednisolone
2016
Completed Phase 3
~140
Ocrelizumab
2016
Completed Phase 3
~5730
Lumbar Puncture
2016
Completed Phase 3
~510
Antihistamine
2016
Completed Phase 3
~220

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,557 Total Patients Enrolled
26 Trials studying Multiple Sclerosis
4,616 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,390 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,224 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When was Ocrelizumab cleared by the FDA?

"Ocrelizumab received a score of 3 on our Power scale. This is due to the fact that this is a Phase 3 trial, and thus there is both evidence of efficacy and safety from multiple rounds of data."

Answered by AI

What other medical studies involving Ocrelizumab have been completed?

"Legacy Health System; Clinical Research & Tech Ctr first studied ocrelizumab in 2008. Since then, there have been 16 completed studies and 29 studies are still recruiting patients. Many of these locations for active recruitment are in Saint Louis, Missouri."

Answered by AI

Which patients would be ideal candidates for this clinical trial?

"This clinical trial is accepting 132 people with primary progressive multiple sclerosis between the ages of 18 and 55. Most notably, patients are required to meet the following criteria: At least one clinically documented relapse in the past year and/or at least one T1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment, Disease duration from the onset of multiple sclerosis symptoms less than (<) 15 years in participants with an EDSS score greater than (>) 5.0 at Screening, Must meet"

Answered by AI

Are more people needed for this experiment?

"This study is not recruiting patients at the moment. The earliest posting date was April 29th, 2016, with the most recent update on October 17th, 2022. 559 other trials are actively searching for participants that have multiple sclerosis, primary progressive. Additionally, 29 other studies are looking for patients that fit the criteria for Ocrelizumab."

Answered by AI

At how many different sites can participants enroll in this research?

"Currently, this clinical trial is underway at 14 different sites. Some of these locations include Saint Louis, San Francisco and Chapel Hill. Please select the clinic nearest to you to avoid extensive travel if you enroll in the trial."

Answered by AI

Could you please tell me if this clinical trial is only open to adults?

"This particular clinical trial is only looking for patients that fall between 18-55 years of age. Out of the 44 trials for people under 18 and 414 for people over 65, this is the only study with this age range."

Answered by AI
~15 spots leftby Apr 2025