Trial Information

Summary: A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Rituximab in Adults with Primary Progressive Multiple Sclerosis PROTOCOL: U2786g

No Compensation Provided

Patient Inclusion/Exclusion Criteria:

1. Ability and willingness to provide written informed consent and to comply with the schedule of protocol assessments.
2. Between the ages of 18 and 65 years.
3. Probable or definitive diagnosis of PPMS.
4. Disease duration of at least 1 year.
5. For subjects of reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) during study treatment and for 1 year following the last dose of study drug.
6. Presence of at least one of the following in a CSF specimen obtained during the screening period and analyzed by the central laboratory or results from a CSF sample obtained during the previous year:
IgG oligoclonal bands
Elevated CSF IgG index

1. History or presence of MS relapse or exacerbation.
2. History or presence of vascular disease potentially affecting the brain or spinal cord (e.g., stroke, transient ischemic attack, carotid stenosis, aortic aneurysm, intracranial aneurysm, hemorrhage, arteriovenous malformation).
3. History or presence of myelopathy due to spinal cord compression by disk or vertebral disease.
4. History of severe, clinically significant central nervous system trauma (e.g., cerebral contusion, spinal cord compression).
5. History of intracranial or intraspinal tumor (e.g., meningioma, glioma).
6. History or presence of potential metabolic cause of myelopathy or encephalopathy (e.g., vitamin B-12 deficiency, thyroid abnormalities).
7. History or presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 [HTLV-1], or herpes zoster myelopathy).
8. History of genetically inherited progressive CNS degenerative disorder (e.g., X-linked adrenoleukodystrophy, hereditary spastic paraparesis).
9. Neuromyelitis optica
10. History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjogren syndrome, Behcet disease).
11. History or presence of sarcoidosis.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.