Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Rocky Mountain MS Research Group, LLC
• Treatments: (T,G)-A-L; Glatiramer Acetate; Rituximab

Criteria

Inclusion Criteria:

• 18 through 55 years of age

• Patients with CIS demonstrating one unifocal neurological event AND at least 2 T2-weighted brain lesions measuring a minimum of 6mm in diameter by MRI analysis; or a definite diagnosis of RMS, as defined by the 2005 revised McDonald criteria(1, 2), and have had at least one clinically defined relapse within the past year OR one GEL on an MRI within the past year

• Women of child-bearing potential must agree to practice an acceptable method of birth control

• No evidence of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (PCNS) lymphoma

• Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization

• Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with local regulatory requirements.

Exclusion Criteria:

• ≥ 15 GELs on baseline MRI

• Treatment with interferon β, natalizumab, or fingolimod within three months of randomization

• Treatment with mitoxantrone, cyclophosphamide, or any other chemotherapeutic agent for MS or malignancy within 12 months of randomization

• Attenuated live virus vaccination within 4 weeks of randomization

• Positive urine and serum pregnancy test at screening or baseline visit

• Any prior treatment with alemtuzumab or cladribine

• Unable to tolerate GA

• History of cardiac arrhythmias, angina or any other significant cardiac abnormalities

• History of clinically significant chronic disease of the immune system or a known immunodeficiency syndrome (HIV) other than MS

• White Blood Cell count of less than 2.5*10^9/L or lymphocyte count below 0.4*10^9/L

• Positive for any evidence of past, or current, hepatitis B and/or C infection

• History or presence of malignancy (except basal cell carcinoma)

• Clinically significant alcohol or drug abuse within past two years

• Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements

• Inability to undergo MRI scans or history of hypersensitivity to gadolinium- diethylenetriamine penta-acetic acid (DTPA)

• Participation in any clinical study evaluating another investigational drug or therapy within three months prior to randomization

• Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study