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Trial record 3 of 22 for:    ocrelizumab

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02861014
First received: August 5, 2016
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: Ocrelizumab
Phase 3

Study Type: Interventional
Study Design: 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 Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Time to First Protocol-Defined Event of Disease Activity [ Time Frame: Baseline up to Week 96 ] [ Designated as safety issue: No ]
  • Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 96 [ Time Frame: Baseline, Week 96 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Annualized Rate of Protocol-Defined Relapses [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Time to Onset of First Protocol-Defined Relapse [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]
  • Time to Onset of 24 Weeks Confirmed Disability Progression (CDP), as Assessed Using EDSS Scale [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]
  • Time to Onset of First New and/or Enlarging T2 Lesion Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]
  • Total Number of T1 Gadolinium-Enhanced Lesions 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 at Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Change From Baseline in Volume of T1 Hypointense Lesions Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Brain Volume Detected by Brain MRI at Weeks 24, 48, and 96 [ Time Frame: Baseline, Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 4.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02861014

Contacts
Contact: Reference Study ID Number: MA30005 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 216 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 
Study First Received: August 5, 2016
Last Updated: November 1, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on December 05, 2016