A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194570
First received: August 28, 2010
Last updated: August 26, 2014
Last verified: August 2014

August 28, 2010
August 26, 2014
March 2011
October 2017   (final data collection date for primary outcome measure)
Efficacy: Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
Efficacy: Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks [ Time Frame: from baseline to sustained disability progression over a 3-year period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01194570 on ClinicalTrials.gov Archive Site
  • Time to sustained disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
  • Change in timed 25-foot walk [ Time Frame: from baseline to Week 120 ] [ Designated as safety issue: No ]
  • Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain [ Time Frame: from baseline to Week 180 ] [ Designated as safety issue: No ]
  • Safety and tolerability: Incidence of adverse events [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
  • Time to sustained disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks [ Time Frame: from baseline to sustained disability progression over a 3-year period ] [ Designated as safety issue: No ]
  • Change in timed 25-foot walk [ Time Frame: from baseline to Week 120 ] [ Designated as safety issue: No ]
  • Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain [ Time Frame: from baseline to Week 180 ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events, laboratory parameters, vital signs, ECG, neurological examination, MRI [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis
A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

This randomized, parallel group, double-blind, placebo controlled study will eva luate the efficacy and safety of ocrelizumab in patients with primary progressiv e multiple sclerosis. Eligible patients will be randomized 2 : 1 to receive eith er ocrelizumab (300 mg intravenously, 2 infusions separated by 14 days in each t reatment cycle) or placebo. The blinded treatment period will be at least 120 we eks, followed by open label treatment for patients in both groups who in the opi nion of the investigator could benefit from further or newly initiated ocrelizum ab treatment. Anticipated time on study treatment is up to 5.5 years.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis, Primary Progressive
  • Drug: Placebo
    Ocrelizumab placebo, 2 infusions separated by 14 days in each treatment cycle
  • Drug: methylprednisolone
    100 mg iv 30 minutes prior to ocrelizumab or placebo infusion
  • Drug: ocrelizumab
    2 intravenous infusions of 300 mg separated by 14 days in each treatment cycle
  • Experimental: A
    Interventions:
    • Drug: methylprednisolone
    • Drug: ocrelizumab
  • Placebo Comparator: B
    Interventions:
    • Drug: Placebo
    • Drug: methylprednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
739
October 2017
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18-55 years of age
  • Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
  • Expanded Disability Status Scale (EDSS) 3 to 6.5 points
  • Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
  • Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose

Exclusion Criteria:

  • History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
  • Contraindications for Magnetic Resonance Imaging (MRI)
  • Known presence of other neurologic disorders
  • Known active infection or history of or presence of recurrent or chronic infection
  • History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
  • Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   Uruguay
 
NCT01194570
WA25046, 2010-020338-25
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP