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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis (AMS05 Trial)

Phase 4
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Immunization with an Food and Drug Administration (FDA) authorized or licensed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccines)
Be between 18 and 65 years old
Must not have
History of Primary Progressive Multiple Sclerosis (PPMS), Progressive Relapsing Multiple Sclerosis (PRMS), or Secondary Progressive Multiple Sclerosis (SPMS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 0, 6, 12, 18, 24, 30, 36, 42, 48
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing if patients with early relapsing multiple sclerosis can stop taking Ocrelizumab after initial treatment without their disease getting worse. Ocrelizumab is a medication given through an IV that helps manage multiple sclerosis by reducing harmful immune cells. The study will monitor patients for new disease activity over several years.

Who is the study for?
This trial is for adults with early Relapsing Multiple Sclerosis (RMS) diagnosed within the last 2 years. Participants must be willing to use effective contraception and have received an FDA-authorized COVID-19 vaccine. Exclusions include pregnancy, certain heart conditions, substance abuse, recent steroid therapy or live vaccines, metal implants affecting MRI scans, other significant diseases or infections like HIV or hepatitis.
What is being tested?
The study tests if it's safe and effective to stop Ocrelizumab (OCR) after initial treatment in RMS patients. It starts with standard OCR doses for a year; then participants are randomly assigned to continue OCR, switch from OCR to placebo at different intervals, or receive placebos only for up to four years.
What are the potential side effects?
Ocrelizumab may cause infusion reactions like rash or fever, infections due to weakened immune response, potential liver issues indicated by blood tests changes. Side effects can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received an FDA-approved COVID-19 vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition is a form of progressive multiple sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 0, 6, 12, 18, 24, 30, 36, 42, 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 0, 6, 12, 18, 24, 30, 36, 42, 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absence of clinical relapse
Secondary study objectives
Proportion of participants experiencing infusion related reactions
Proportion of participants who experience at least one Grade 3 or higher adverse event
The change in Expanded Disability Status Scale (EDSS) score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ocrelizumab ArmExperimental Treatment1 Intervention
All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6, 12, 18, and 24. In this arm participants will continue to receive OCR infusions every 6 months through Month 48.
Group II: Placebo ArmPlacebo Group1 Intervention
All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6, 12, 18, and 24. In this arm, starting at Month 30, participants will receive placebo infusions every 6 months through Month 48.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 4
~10080

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Ocrelizumab is a monoclonal antibody that targets CD20-positive B cells, which are implicated in the autoimmune response that damages myelin in Multiple Sclerosis (MS). By depleting these B cells, Ocrelizumab reduces inflammation and slows disease progression. Other common treatments include beta interferons and glatiramer acetate, which modulate the immune response to reduce the frequency of relapses and the formation of new lesions. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the central nervous system. These treatments are crucial for MS patients as they help manage symptoms, reduce relapses, and slow the progression of disability, thereby improving quality of life.
Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,326 Previous Clinical Trials
5,365,754 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
4,119 Patients Enrolled for Multiple Sclerosis
Genentech, Inc.Industry Sponsor
1,564 Previous Clinical Trials
570,523 Total Patients Enrolled
27 Trials studying Multiple Sclerosis
4,586 Patients Enrolled for Multiple Sclerosis
Autoimmunity Centers of Excellence (ACE)UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05285891 — Phase 4
Multiple Sclerosis Research Study Groups: Ocrelizumab Arm, Placebo Arm
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT05285891 — Phase 4
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285891 — Phase 4
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05285891 — Phase 4
~80 spots leftby Aug 2028