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