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Ocrelizumab for Multiple Sclerosis (AMS05 Trial)
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.
AMS05 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAMS05 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AMS05 Trial Design
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- Examples of birth control methods include getting your tubes tied, using hormone-based birth control, or using intrauterine devices.I have had symptoms or an episode of MS within the last 2 years that meets specific criteria.I understand and commit to reliable contraception methods during the trial.I have had symptoms or an episode of MS within the last 2 years that meets specific criteria.My condition is a form of progressive multiple sclerosis.My disease symptoms started less than 2 years ago.I use barrier methods with spermicide for contraception.I have received an FDA-approved COVID-19 vaccine.If you use barrier methods of contraception, like condoms, you need to also use a special gel or foam called spermicide to make it more effective.Birth control methods like tubes tied, vasectomy, hormonal birth control, and certain intrauterine devices.My symptoms started less than 2 years ago.I am a woman who can still have children.
- Group 1: Ocrelizumab Arm
- Group 2: Ocrelizumab+Placebo Arm
- Group 3: Placebo Arm
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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