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An Open-Label, Multicenter, Biomarker Study To Explore The Mechanism Of Action Of Ocrelizumab And B-Cell Biology In Patients With Relapsing Multiple Sclerosis Or Primary Progressive Multiple Sclerosis

Clinical Trial Details

Relapsing Multiple Sclerosis (RMS):
The purpose of this study is to investigate the impact of ocrelizumab on certain biomarkers of RMS in subjects with RMS. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.

Ocrelizumab is a type of drug called a monoclonal antibody. Monoclonal antibodies act like your body’s immune system and attach to certain cells in order to attack germs and other illnesses in your body. Ocrelizumab attaches to certain types of cells (B cells) that are thought to play a role in multiple sclerosis (MS) and removes them from the body.

The purpose of this study is to find out what effects, good or bad, ocrelizumab has on you and your RMS. This study will also look at the way ocrelizumab may change certain biomarkers related to RMS in your body.

Primary Progressive Multiple Sclerosis (PPMS):
The purpose of this study is to investigate the impact of ocrelizumab on certain biomarkers of PPMS in subjects with PPMS. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.

Ocrelizumab is a type of drug called a monoclonal antibody. Monoclonal antibodies act like your body’s immune system and attach to certain cells in order to attack germs and other illnesses in your body. Ocrelizumab attaches to certain types of cells (B cells) that are thought to play a role in multiple sclerosis (MS) and removes them from the body.

The purpose of this study is to find out what effects, good or bad, ocrelizumab has on you and your PPMS. This study will also look at the way ocrelizumab may change certain biomarkers related to PPMS in your body.

Key Eligibility: 

Inclusion Criteria:

- Aged 18 to 55 years old

- Specific to relapsing remitting multiple sclerosis patients:

  • Disease duration of less than 15 years
  • Either treatment-naïve or receiving treatment with disease-modifying therapies, including prior use of IFN-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®)
  • At least one clinically documented relapse in the past year and/or at least one T1-weighted Gd-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment

- Specific to primary progressive multiple sclerosis patients:

  • Disease duration of less than 10 years with an EDSS greater than 5.0

Exclusion Criteria:

- Diagnosis of secondary progressive multiple sclerosis

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Blagovest Nikolov
bln2001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1610017671

ClinicalTrials.gov:

NCT02688985

Status

Not Yet Recruiting

Age Group

Adult

Sponsor