A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

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ClinicalTrials.gov Identifier: NCT02861014

Recruitment Status : Active, not recruiting

First Posted : August 10, 2016

Last Update Posted : September 7, 2018

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief Summary:

The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Biological: Ocrelizumab	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	681 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
Actual Study Start Date :	September 9, 2016
Estimated Primary Completion Date :	January 1, 2021
Estimated Study Completion Date :	January 1, 2021

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Ocrelizumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ocrelizumab Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.	Biological: Ocrelizumab Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72. Other Name: RO4964913

Outcome Measures

Primary Outcome Measures :

Percentage of Participants With No Evidence of Disease Activity (NEDA) as per Protocol Defined Events During a 96-Week Period [ Time Frame: 96 weeks ]

Secondary Outcome Measures :

Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 and 48 Weeks Period [ Time Frame: Baseline up to 24 weeks, Baseline up to 48 weeks ]
Time to First Protocol-Defined Event of Disease Activity [ Time Frame: Baseline up to Week 96 ]
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 96 [ Time Frame: Baseline, Week 96 ]
Percentage of Participants With Confirmed Disability Improvement (CDI), Confirmed Disability Progression (CDP), or Stable Disability, as Assessed Using EDSS Scale [ Time Frame: Up to Week 96 ]
Annualized Rate of Protocol-Defined Relapses [ Time Frame: Week 96 ]
Time to Onset of First Protocol-Defined Relapse [ Time Frame: Up to Week 96 ]
Time to Onset of 24 Weeks Confirmed Disability Progression (CDP), as Assessed Using EDSS Scale [ Time Frame: Up to Week 96 ]
Time to Onset of First New and/or Enlarging T2 Lesion Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Up to Week 96 ]
Total Number of T1 Gadolinium-Enhanced Lesions Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
Change From Baseline in Total T2 Lesion Volume Detected by Brain MRI at Week 96 [ Time Frame: Baseline, Week 96 ]
Change From Baseline in Volume of T1 Hypointense Lesions Detected by Brain MRI at Weeks 48 and 96 [ Time Frame: Baseline, Weeks 48 and 96 ]
Change From Baseline in Number of T1 Hypointense Lesions Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ]
Change From Baseline in Brain Volume Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ]
Change From Baseline in Cognitive Performance at Week 48 and 96 as Measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery [ Time Frame: Baseline, Weeks 48 and 96 ]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 4.5 years ]
Volume of New and/or Enlarging T2 Hyperintense Lesions from Baseline to Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ]
Number of New and/or Enlarging T2 Hyperintense Lesions from Baseline to Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
Have a length of disease duration, from first symptom, of less than (<) 10 years
Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
Suboptimal disease control while on a DMT
Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
Inability to complete an Magnetic Resonance Imaging (MRI) procedure
Known presence of other neurological disorders
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History or currently active primary or secondary immunodeficiency
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
History of opportunistic infections
History or known presence of recurrent or chronic infection
History of malignancy
Congestive heart failure
Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861014

Show 195 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02861014 History of Changes
Other Study ID Numbers:	MA30005 2015-005597-38 ( EudraCT Number )
First Posted:	August 10, 2016 Key Record Dates
Last Update Posted:	September 7, 2018
Last Verified:	September 2018

Additional relevant MeSH terms:


Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS	Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases

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