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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 0, 6, 12, 18, 24, 30, 36, 42, 48
Awards & highlights

AMS05 Trial Summary

This trial is testing whether it is necessary to keep receiving the drug ocrelizumab to prevent relapses in patients with early RRMS. 600 mg of ocrelizumab is given at days 0 and 14, then every 6 months for the next 2 years. At month 12, patients are randomized to one of three groups: Arm 1 receives placebo infusions every 6 months; Arm 2 switch to placebo infusions after month 24; Arm 3 continues receiving ocrelizumab every 6 months. The treatment period will be for a total of 48 months.

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.Check my eligibility
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.See study design
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.

AMS05 Trial 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.

AMS05 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absence of clinical relapse
Secondary outcome measures
Proportion of granulocyte-macrophage colony-stimulating factor (GM-CSF) expressing B-Cells to Interleukin 10 (IL-10) expressing B cells at Month 48 in participants who do versus do not exhibit durable disease remission
Proportion of participants experiencing infusion related reactions
Proportion of participants who experience at least one Grade 3 or higher adverse event
+4 more

AMS05 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ocrelizumab+Placebo ArmExperimental Treatment2 Interventions
All eligible participants will be initiated on Ocrelizumab (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 and Month 12. In this arm participants will then receive OCR infusions at Months 18 and 24 and then after Month 24 switch to placebo infusions every 6 months through Month 48.
Group II: 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 and Month 12. In this arm participants will continue to receive OCR infusions every 6 months through Month 48.
Group III: 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 and Month 12. In this arm, starting at Month 18, 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 3
~5730

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,266 Previous Clinical Trials
5,483,922 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
4,119 Patients Enrolled for Multiple Sclerosis
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,578 Total Patients Enrolled
26 Trials studying Multiple Sclerosis
4,573 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, Ocrelizumab+Placebo 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

Frequently Asked Questions

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

Does this study permit the participation of seniors over 65 years old?

"This clinical trial is seeking out individuals aged between 18 and 55 years old."

Answered by AI

Are there still opportunities to enroll in this trial?

"This particular medical trial, as indicated by its document on clinicaltrials.gov, is not in the process of recruiting patients at this time. It was initially posted October 31st 2022 and modified September 19th 2022; however, there are 549 other trials that require volunteers currently."

Answered by AI

How hazardous is the administration of Ocrelizumab to humans?

"The safety of Ocrelizumab has been confirmed in a Phase 4 trial, thus Power rated it 3 on the scale."

Answered by AI

Is the clinical trial for this research distributed across multiple sites in North America?

"Presently, this research trial is recruiting individuals from 12 different sites located in cities such as Dallas, Worcester and New Haven. To minimize travel demands associated with participating, it may be beneficial to select the most proximate medical centre."

Answered by AI

Could I potentially qualify as a participant in this trial?

"This clinical trial is looking to recruit 175 individuals between the ages of 18 and 55 who have been diagnosed with multiple sclerosis. To qualify, they must be able to provide evidence related to their preferred lifestyle that confirms sexual abstinence throughout the duration of the study; additionally, any form of periodic abstinence such as calendar or ovulation tracking methods are not accepted forms of contraception. The individual should also have had a single MS episode in accordance with McDonald 2017 criteria for up two years post-event and an overall length of illness no greater than 2 years; further still, females interested in participating must not be postmenopausal or have undergone surgical sterilization (rem"

Answered by AI

Who else is applying?

What state do they live in?
California
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
What site did they apply to?
New York University Langone Health: Multiple Sclerosis Comprehensive Care Center

What questions have other patients asked about this trial?

Will I have to travel? Are there side effects?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I seek a cure for MS. I am currently on half dose Ocrevus. I had full dose then it knocked my B cells out for 18 months and have recently ( last September) had half dose. Neither dose seems to help at all.
PatientReceived 2+ prior treatments
~117 spots leftby Aug 2028