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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02637856
• Date of registration: 18/12/2015
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: 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)
• Scientific 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
• Date of first enrolment: February 11, 2016
• Target sample size: 608
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02637856
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 (
- Treated with an adequate course of treatment with no more than three prior DMT
regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the
most recent adequately used DMT was due to suboptimal response

- Suboptimal response while the participant was on his/her last adequately used DMT for
>/=6 months (defined by having one of the following qualifying events despite being on
a stable dose of the same DMT for at least 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); these qualifying events must have occurred while on the last
adequately used DMT. 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 from the date of screening

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, or intention to become pregnant during the study

- 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 human immunodeficiency virus (HIV), syphilis, or tuberculosis

- History of progressive multifocal leukoencephalopathy

- Contraindications to or intolerance of oral or IV corticosteroids

- Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in
participants whose lymphocyte count is below the lower limit of normal (LLN)

- Treatment with alemtuzumab (Lemtrada®)

- Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate
mofetil, cyclosporine, or methotrexate

- Previous treatment with natalizumab within 12 months prior to screening unless failure
was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously
treated with natalizumab will be eligible for this study only if duration of treatment
with natalizumab was less than (<) 1 year and natalizumab was not used in the 12
months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive
or negative) and titer (both assessed within the year of screening) must be documented
prior to enrollment

- Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to
screening

- Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept,
belimumab, or ofatumumab)

- Treatment with a drug that is experimental (Exception: treatment with an experimental
drug that was subsequently approved in the participant's country is allowed)



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Ocrelizumab

Primary Outcome(s)

Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period [Time Frame: Baseline up to Week 96]

Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy [Time Frame: Week 96 to Week 100]

Secondary Outcome(s)

Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI [Time Frame: Weeks 24, 48, and 96]

Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI [Time Frame: Baseline up to Week 96]

Time to Onset of First Protocol-Defined Relapse [Time Frame: Baseline up to Week 96]

Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI [Time Frame: Baseline, Weeks 24, 48, and 96]

Percentage of Participants With Adverse Events [Time Frame: Baseline up to 100 weeks]

Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI [Time Frame: Baseline up to Week 96]

Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period [Time Frame: Baseline up to Week 96]

Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score [Time Frame: Baseline up to Week 96]

Time to Protocol-Defined Event [Time Frame: Baseline up to Week 96]

Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period [Time Frame: Baseline up to Weeks 24 and 48]

Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI [Time Frame: Weeks 24, 48, and 96]

Secondary ID(s)

MN30035

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02637856