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Archive for the tag “volunteer”

Researchers Recruiting People with Primary Progressive MS for Genetics Studies – Key to finding treatment options

Primary progressive MS is characterized by steadily worsening neurologic function from the onset of the disease. There are still many gaps in the knowledge we have about what differentiates relapsing-remitting from primary progressive MS, and the underlying mechanisms of primary progressive MS. The MS Genetics Group at the University of California San Francisco is recruiting people with primary progressive MS for a research study involving a one-time blood sample donation with the goal of identifying genetic factors driving the course of the disease. The team also is looking for people without MS who are not related to serve as controls. The team hopes to identify the major genetic factors that play a role in disease presentation and progression. Please note: you do not have to be located in or travel to California to participate. Everything for the study can be done remotely and is free of charge to participants.

Rationale: Specific subtle variations in the human genome are known to play a role in determining who is susceptible to developing multiple sclerosis, and may also influence the course of the disease. People living with MS can make a difference in studies searching for these genes by donating their DNA with a blood sample. Identifying the exact location and role of MS genes could help determine who is at risk for developing the disease and can provide clues to its cause, prevention, and lead to better treatments.

Details: Once an individual has completed the initial online intake form, they will receive a call from the study coordinator to discuss details and answer any questions. The consent form and health information privacy form can be signed electronically. Participants will then be emailed a link to two additional short online surveys and sent a blood-collection kit. The kit includes everything necessary for the blood draw, which can be taken to your local Quest Diagnostics Lab and returned in a prepaid envelope to the lab at UCSF. There is no cost to participants.

Contact: To participate or request additional information, please complete a brief intake survey.
OR you may contact UCSF directly:
Clinical Research Coordinator
UCSF Multiple Sclerosis Genetic Susceptibility Project
675 Nelson Rising Lane, Suite 235A, Box 3206
San Francisco, CA 94158
Email: msdb@ucsf.edu
Toll Free Phone: 1-866-MS-Genes (1-866-674-3637) or Office Phone: (415) 502-7202

 

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MS Trial Alert: Researchers Recruiting People with Relapsing MS for Antibody Study

Summary: Investigators at seven sites in the United States are recruiting at least 24 people with relapsing MS for a study of ublituximab (TG Therapeutics, Inc.), an experimental monoclonal antibody administered via intravenous infusion. At most, 100 people will be enrolled.

Rationale: Ublituximab is a new monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and depletes them from circulation. B cells have several functions including making antibodies, and evidence suggests they play a role in immune-system mediated damage to brain and spinal cord tissues in MS. Other therapies targeting B cells (rituximab, ocrelizumab) have shown some benefit in clinical trials. Ublituximab binds to CD20 in a unique way, and thus may have greater B cell depletion capabilities than similar agents. Clinical trials are ongoing in people with blood cancer as well.

Eligibility and Details: Participants should be aged 18 to 55, have a diagnosis of relapsing MS, and have had more than one relapse in the previous two years. Further enrollment criteria are available from the contact below.

Participants are initially randomly assigned to receive either ublituximab or placebo infusions (infusions range from 1 to 4 hours).  After 28 days, participants receiving placebo will receive ublituximab.

The primary outcomes being measured are the levels of B cell depletion, and the number of participants who experience adverse events. Secondary outcomes include monitoring relapses and MRI-detected disease activity.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Koby Mok, PhD, via e-mail at kmok@tgtxinc.com, or by phone at 949-422-2468.

Sites are enrolling in the following cities:
Fort Collins, CO
Lexington, KY
San Antonio, TX
Knoxville, TN
Columbus, OH
Phoenix, AZ
Round Rock, TX

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

MS Trial Alert: Investigators Nationwide Recruiting People with MS for Phase I Study to Determine Safety of Experimental Antibody in Treating Relapse

Summary: Investigators nationwide are recruiting 30 people with MS for a phase I study to determine the safety and tolerability of rHIgM22, an experimental antibody. Participants may remain on their current therapy throughout the study. The study is enrolling participants experiencing a clinical acute relapse (new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days) and with at least one new, active lesion (damaged area) on MRI scans. The study is funded by Acorda Therapeutics, Inc.

Rationale: Although the body repairs some damage to nerve-insulating myelin that occurs in MS, this repair is insufficient. One strategy under study is to stimulate the body’s own internal repair capabilities. With funding from the Hilton Foundation, NIH, the National MS Society and others, Moses Rodriguez, MD, and colleagues (Mayo Clinic Foundation) identified a human antibody – rHIgM22 – that targets and attaches to myelin-making cells. When given to mice with an experimental MS-like disease, rHIgM22 promotes myelin repair. This antibody was well tolerated in another phase I study (trial NCT01803867, as listed on clinicaltrials.gov) in 55 people with all types of MS. (Abstract #P4.339, Annual Meeting of the American Academy of Neurology 2015)

Eligibility and Details: Men and women between the ages of 18 and 70 with a diagnosis of MS are eligible. The study is enrolling participants with a clinical acute relapse; an MRI will be performed to confirm that there is an active lesion (damaged area). There are detailed exclusion criteria related to laboratory, cardiac, immune and other factors. For more information on these criteria, please use the contact information below.

Participants will remain on their current therapy throughout the study. Upon entering the study with an acute relapse, subjects will receive high-dose oral steroids for five days, a standard treatment for an acute relapse. Following completion of the oral steroids for the acute relapse the subjects will receive either a single dose of rHIgM22 or placebo.

Investigators are testing 2 dose levels. For each dose, 10 participants are being randomly assigned to receive active treatment (rHIgM22) and 5 are being randomly assigned to receive inactive placebo, both via a single intravenous infusion. Blood samples will be collected from participants before and at specified times for up to 48 hours after dosing, so participants must agree to remain in the hospital for that time. Participants are being followed for 180 days after dosing, which includes return visits to the clinic and MRI scans.

The primary outcome of the study is to determine the safety and tolerability of rHIgM22 in people with MS. Adverse events are being monitored throughout the study. The investigators will also evaluate how this experimental treatment is absorbed in the body, and how the immune and nervous systems react to it. Phase I studies are the first of three stages of clinical trials that determine whether an exploratory treatment is safe and beneficial.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Kevin Cronin, Manager Corporate Communications, kcronin@acorda.com, 914-326-5279, or visit the trial’s listing on clinicaltrials.gov to find the site nearest you.

Sites are recruiting in the following cities:

Aurora, CO
Centennial, CO (Denver metro-area)
Dallas, TX
Indianapolis, IN
Long Beach, CA
Rochester, NY
Sacramento, CA
Saint Louis, MO
San Francisco, CA
Seattle, WA
Stanford, CA
Teaneck, NJ (NY metro area)

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

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