Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Ocrelizumab in Participants 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: December 7, 2016
Last verified: December 2016

August 28, 2010
December 7, 2016
March 2011
July 2015   (final data collection date for primary outcome measure)
Time to Onset of Confirmed 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 up to Week 120 ] [ 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 Onset of Confirmed Disability Progression, Defined as an Increase in EDSS Score That is Sustained for at Least 24 Weeks [ Time Frame: From baseline up to Week 120 ] [ Designated as safety issue: No ]
  • Change in 25-Foot Timed Walk From Baseline to Week 120 [ Time Frame: Baseline, Week 120 ] [ Designated as safety issue: No ]
  • Change in Total Volume of T2 Lesions on Magnetic Resonance Imaging (MRI) Scans of the Brain From Baseline to Week 120 [ Time Frame: Baseline, Week 120 ] [ Designated as safety issue: No ]
  • Percent Change in Total Brain Volume as Detected by Brain MRI From Week 24 to Week 120 [ Time Frame: Week 24, Week 120 ] [ Designated as safety issue: No ]
  • Change in Short Form-36 Version 2 (SF-36 v2) Physical Component Summary (PCS) Score From Baseline to Week 120 [ Time Frame: Baseline, Week 120 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to Week 120 ] [ 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 Participants 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 evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants will continue their treatment with open-label ocrelizumab until the last participant who entered the OLE phase reaches 4 years of open-label ocrelizumab treatment.
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: Ocrelizumab
    Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.
  • Other: Placebo
    Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
  • Experimental: Ocrelizumab
    Participants will receive two intravenous (IV) infusions of ocrelizumab 300 milligrams (mg) separated by 14 days in each treatment cycle of double blind treatment period. Participants who will get benefit from treatment and willing to continue in OLE phase, will receive two IV infusions of ocrelizumab 300 mg separated by 14 days for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase. (Each treatment cycle = 24 weeks)
    Intervention: Drug: Ocrelizumab
  • Placebo Comparator: Placebo
    Participants will receive two IV infusions of placebo matched to ocrelizumab separated by 14 days in each treatment cycle of double blind treatment period. Participants willing to continue in OLE phase, will receive two IV infusions of ocrelizumab 300 mg separated by 14 days for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase. (Each treatment cycle = 24 weeks)
    Interventions:
    • Drug: Ocrelizumab
    • Other: Placebo
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
736
April 2021
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
  • EDSS at screening from 3 to 6.5 points
  • Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0
  • Sexually active male and female participants 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 MS, secondary progressive, or progressive relapsing MS at screening
  • Inability to complete an MRI (contraindications for 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-cluster of differentiation 4 (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   (Adult)
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
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2016

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