Completed

OLYMPUSA Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

placebo

+ rituximab

Drug
Who is being recruted

Autoimmune Diseases+9

+ Chronic Disease

+ Demyelinating Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorGenentech, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.

Official TitleA Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis 
Principal SponsorGenentech, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

439 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesChronic DiseaseDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesPathologic ProcessesSclerosisAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMultiple Sclerosis, Chronic ProgressiveDisease Attributes

Criteria

Inclusion Criteria: * Definitive diagnosis of PPMS * Disease duration of ≥ 1 year * EDSS at baseline between 2.0 and 6.5 points, inclusive * Score of ≥ 2.0 on the Functional Systems (FS) scale for the pyramidal system or gait that is due to lower extremity findings * 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 24 months: * 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 Exclusion Criteria: * Pregnancy or lactation * Incompatibility with MRI * Lack of peripheral venous access * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * Known active bacterial, viral, fungal, mycobacterial, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes zoster or simplex infections) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening * History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis) * History of cancer, including solid tumors and hematologic malignancies (except resected and fully resolved cutaneous basal cell and squamous cell carcinomas) * History of alcohol or drug abuse within 6 months prior to screening * History of or currently active primary or secondary immunodeficiency * Significant cardiac or pulmonary disease (including obstructive pulmonary disease) * Presence of other significant, uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease that might interfere with a subject's ability to participate and to complete approximately 2.5 years of study participation * History or presence of MS relapse or exacerbation * 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) * History or presence of myelopathy due to spinal cord compression by disk or vertebral disease * History of severe, clinically significant central nervous system trauma (e.g., cerebral contusion, spinal cord compression) * History of intracranial or intraspinal tumor (e.g., meningioma, glioma) * History or presence of potential metabolic cause of myelopathy or encephalopathy (e.g., vitamin B12 deficiency, thyroid abnormalities) * 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) * History of genetically inherited progressive CNS degenerative disorder (e.g., X-linked adrenoleukodystrophy, hereditary spastic paraparesis) * Neuromyelitis optica * History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sj�gren syndrome, Beh�et disease) * History or presence of sarcoidosis * Previous treatment with rituximab (MabThera(R)/Rituxan(R)) * Previous treatment with lymphocyte-depleting therapies (e.g., cyclophosphamide, Campath(R), anti-CD4, cladribine, total body irradiation, bone marrow transplantation), except mitoxantrone, which should not be used 12 months prior to randomization * Treatment with an investigational agent within 90 days or 5 half-lives of the investigational drug (whichever is longer) prior to randomization * Receipt of a live vaccine within 30 days prior to randomization * Systemic corticosteroid therapy within 30 days prior to randomization * Treatment with IFN-\β, glatiramer acetate, IVIg, or plasmapheresis within 60 days prior to randomization * Treatment with non-lymphocyte-depleting immunosuppressive therapies (e.g., azathioprine, mycophenolate mofetil \[MMF\], cyclosporine) within 90 days prior to randomization * Statins or hormone replacement therapy started within 30 days prior to randomization

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers