A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 March 2023
• Main ID: NCT01247324
• Date of registration: 23/11/2010
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
• Scientific title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
• Date of first enrolment: August 31, 2011
• Target sample size: 821
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01247324
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Tunisia, Ukraine, United Kingdom, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria
(2010)

- At least 2 documented clinical attacks within the last 2 years prior to screening or
one clinical attack in the years prior to screening (but not within 30 days prior to
screening)

- Neurologic stability for greater than or equal to (>=) 30 days prior to both screening
and baseline

- Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

- Primary progressive multiple sclerosis

- Disease duration of more than 10 years in participants with EDSS less than or equal to
(<=) 2.0 at screening

- Contraindications for MRI

- Known presence of other neurological disorders which 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

- 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
(e.g., hepatitis B or C, human immunodeficiency virus [HIV], syphilis, tuberculosis)

- History of progressive multifocal leukoencephalopathy

- Contraindications to or intolerance of oral or iv corticosteroids

- Contraindications to Rebif or incompatibility with Rebif use



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

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Ocrelizumab

Drug: Ocrelizumab-matching placebo

Drug: Interferon beta-1a-matching placebo

Drug: Interferon beta-1a

Primary Outcome(s)

Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks [Time Frame: Week 96]

Secondary Outcome(s)

Number of T1 Hypointense Lesions During the Double-Blind Treatment [Time Frame: Baseline up to Week 96]

Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period [Time Frame: Week 108]

Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96 [Time Frame: Baseline, Week 96]

Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment [Time Frame: Baseline up to Week 96]

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96 [Time Frame: Baseline, Week 96]

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline up to Week 96]

Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96 [Time Frame: From Week 24 up to Week 96]

Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment [Time Frame: Baseline up to Week 96]

Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks [Time Frame: Week 96]

Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96 [Time Frame: Week 96]

Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC) [Time Frame: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96]

Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab [Time Frame: Baseline up to week 96]

Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period [Time Frame: Week 108]

Secondary ID(s)

WA21092

2010-020337-99

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01247324