A Study of Ocrelizumab: Phase III - CHORDS MN30085

I thought that I would post additional information about the study that I am participating in.  All of this material is on the clinicaltrials.gov website, and is subject to change at any time.

Sponser:  Genentech            clinicaltrials.gov Identifier:  NCT02637856

As of this blog post, this study is still looking for participants.

Purpose:  This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligram (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion every 24 weeks for the study duration. Anticipated time on study treatment is 96 weeks.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS WHO HAVE HAD A SUBOPTIMAL RESPONSE TO AN ADEQUATE COURSE OF DISEASE MODIFYING TREATMENT

Primary Outcome Measures:

• Percentage of Participants Without Any Protocol-Defined Events (Relapse, T1 Lesion, New and/or Enlarging T2 Lesion, Confirmed Disability Progression) During 96-Week Period [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Percentage of Participants Without Any Protocol-Defined Events (Relapse, T1 Lesion, New and/or Enlarging T2 Lesion, Confirmed Disability Progression) During 24-Week Period and 48-Week Period [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
• Time to Protocol-Defined Event (Relapse, T1 Lesion, New and/or Enlarging T2 Lesion, Confirmed Disability Progression) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Percentage of Participants Per Year with Protocol-Defined Relapse [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of First Protocol-Defined Relapse [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of First T1 Gadolinium (Gd)-Enhanced Lesion as Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Time to Onset of Confirmed Disability Progression for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
• Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
• Change From Baseline in Total T2 Lesion Volume Detected by Brain MRI [ Time Frame: Baseline to Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
• Total Number of New and/or Enlarging T2 Lesions Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)

Genders Eligible for Study:   Both

Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

• Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria
• Disease duration from first symptom of less than or equal to (</=) 10 years
• Treated with or received no more than two prior DMT regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the most recent DMT was due to lack of efficacy
• Suboptimal disease control while the participant was on his/her last DMT for >/=6 months (defined by having one of the following despite being on a stable dose of the same DMT for >/=6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); in participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT

Exclusion Criteria:

• History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
• Contraindications for MRI
• Known presence of other neurological disorders that may mimic multiple sclerosis
• Pregnancy or lactation
• Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• History of or currently active primary or secondary immunodeficiency
• Lack of peripheral venous access
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Active infection, or history of or known presence of recurrent or chronic infection such as hepatitis B or C, human immunodeficiency virus (HIV), syphilis, or tuberculosis
• History of progressive multifocal leukoencephalopathy
• Contraindications to or intolerance of oral or IV corticosteroids

Additional information can be found on the clinicaltrials.gove website for study NCT02637856

***All information on this page is from https://clinicaltrials.gov/ct2/show/NCT02637856