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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
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis, Primary Progressive
Drug: Ocrelizumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 736
Study Start Date: March 2011
Estimated Study Completion Date: April 2021
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.
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)
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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194570

  Show 217 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194570     History of Changes
Other Study ID Numbers: WA25046  2010-020338-25 
Study First Received: August 28, 2010
Last Updated: December 7, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 09, 2016