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: January 6, 2017
Last verified: January 2017
  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
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 ]

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 ]
  • Change in 25-Foot Timed Walk From Baseline to Week 120 [ Time Frame: Baseline, Week 120 ]
  • 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 ]
  • Percent Change in Total Brain Volume as Detected by Brain MRI From Week 24 to Week 120 [ Time Frame: Week 24, Week 120 ]
  • 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 ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to Week 120 ]

Enrollment: 732
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)
Sexes Eligible for Study:   All
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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85013
Phoenix, Arizona, United States, 85050
Scottsdale, Arizona, United States, 85259
United States, California
Berkeley, California, United States, 94705
Newport Beach, California, United States, 92663
Sacramento, California, United States, 95817
San Francisco, California, United States, 94143
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Bradenton, Florida, United States, 34205
Maitland, Florida, United States, 32751
Miami, Florida, United States, 33136
Tampa, Florida, United States, 33609
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30322
Atlanta, Georgia, United States, 30327
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Kansas
Kansas City, Kansas, United States, 66160
Lenexa, Kansas, United States, 66214
United States, Michigan
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Golden Valley, Minnesota, United States, 55422
Minneapolis, Minnesota, United States, 55414
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New Jersey
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany, New York, United States, 12208
Mineola, New York, United States, 11501
New York, New York, United States, 10021
New York, New York, United States, 10029
Patchogue, New York, United States, 11772
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11794
United States, North Carolina
Advance, North Carolina, United States, 27006
Charlotte, North Carolina, United States, 28207
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
Cordova, Tennessee, United States, 38018
United States, Texas
Dallas, Texas, United States, 75390-8897
Houston, Texas, United States, 77030
Round Rock, Texas, United States, 78681
United States, Virginia
Henrico, Virginia, United States, 23226
United States, Washington
Seattle, Washington, United States, 98122
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53215
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
Heidelberg, Victoria, Australia, 3084
Austria
Innsbruck, Austria, 6020
Linz, Austria, 4020
Linz, Austria, 4021
Salzburg, Austria, 5020
Villach, Austria, 9500
Wien, Austria, 1090
Belgium
La Louvière, Belgium, 7100
Leuven, Belgium, 3000
Sijsele, Belgium, 8340
Brazil
Goiania, GO, Brazil, 74605-020
Belo Horizonte, MG, Brazil, 30150-221
Rio de Janeiro, RJ, Brazil, 22290-240
Porto Alegre, RS, Brazil, 90610-000
Bulgaria
Pleven, Bulgaria, 5800
Sofia, Bulgaria, 1113
Sofia, Bulgaria, 1309
Sofia, Bulgaria, 1407
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R8A 1R9
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal, Quebec, Canada, H3A 2B4
Czech Republic
Brno, Czech Republic, 625 00
Praha 2, Czech Republic, 128 08
Teplice, Czech Republic, 415 29
Denmark
Sønderborg, Denmark, 6400
Finland
Helsinki, Finland, 00290
Tampere, Finland, 33520
Turku, Finland, 20100
Turku, Finland, 20520
France
Besancon, France, 25030
Bordeaux, France, 33076
Bron, France, 69677
Caen, France, 14033
Clermont-Ferrand, France, 63003
Lille, France, 59037
Marseille, France, 13005
Montpellier, France, 34295
Nancy, France, 54035
Nantes, France, 44805
Nice, France, 06002
Nimes, France, 30029
Paris, France, 75019
Paris, France, 75651
Poissy, France, 78300
Reims, France, 51092
Strasbourg, France, 67091
Toulouse, France, 31059
Germany
Bayreuth, Germany, 95445
Berg, Germany, 82335
Berlin, Germany, 10117
Berlin, Germany, 13347
Bochum, Germany, 44789
Dresden, Germany, 01307
Düsseldorf, Germany, 40225
Frankfurt am Main, Germany, 60528
Gießen, Germany, 35385
Heidelberg, Germany, 69120
Köln, Germany, 51067
Leipzig, Germany, 04103
Marburg, Germany, 35032
Munich, Germany, 81675
Münster, Germany, 48149
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Ulm, Germany, 89081
Wiesbaden, Germany, 65191
Greece
Athens, Greece, 11525
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 57010
Hungary
Budapest, Hungary, 1033
Budapest, Hungary, 1145
Budapest, Hungary, 1204
Esztergom, Hungary, 2500
Pécs, Hungary, 7623
Szeged, Hungary, 6720
Veszprem, Hungary, 8200
Israel
Ashkelon, Israel, 78278
Haifa, Israel, 31048
Petach Tikva, Israel, 49100
Ramat-Gan, Israel, 52621
Safed, Israel, 13100
Tel Aviv, Israel, 6423906
Italy
Genova, Liguria, Italy, 16132
Milano, Lombardia, Italy, 20132
Orbassano, Piemonte, Italy, 10043
Cagliari, Sardegna, Italy, 09126
Lithuania
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 92288
Siauliai, Lithuania, 76231
Mexico
Aguascalientes, Mexico, 20127
Mexico City, Mexico, 14390
Mexico, Mexico, 03600
Monterrey, Mexico, 64620
Netherlands
Rotterdam, Netherlands, 3015 CE
Sittard-Geleen, Netherlands, 6162 BG
New Zealand
Hamilton, New Zealand, 3240
Wellington, New Zealand, 6021
Norway
Oslo, Norway, 0407
Peru
Bellavista, Peru, Callao 2
Lima, Peru, 18
Lima, Peru, Lima 1
Poland
Bialystok, Poland, 15-402
Jaroslaw, Poland, 37-500
Katowice, Poland, 40-594
Katowice, Poland, 40-752
Konskie, Poland, 26-200
Lodz, Poland, 90-153
Lublin, Poland, 20-954
Plewiska, Poland, 62-064
Poznan, Poland, 60-355
Portugal
Almada, Portugal, 2801-951
Amadora, Portugal, 2720-276
Coimbra, Portugal, 3000-075
Coimbra, Portugal, 3041-801
Lisboa, Portugal, 1169-050
Lisboa, Portugal, 1649-035
Porto, Portugal, 4099-001
Romania
Bucharest, Romania, 011461
Bucharest, Romania, 060011
Campulung, Romania, 115100
Targu Mures, Romania, 540136
Timisoara, Romania, 300736
Russian Federation
Kazan, Russian Federation, 420103
Spain
San Sebastian, Guipuzcoa, Spain, 20014
Santiago de Compostela, La Coruña, Spain, 15706
Bilbao, Vizcaya, Spain, 48013
Alicante, Spain, 03010
Barcelona, Spain, 08003
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Girona, Spain, 17007
Madrid, Spain, 28006
Madrid, Spain, 28034
Madrid, Spain, 28040
Malaga, Spain, 29010
Sevilla, Spain, 41009
Switzerland
Basel, Switzerland, 4031
Lugano, Switzerland, 6903
Zürich, Switzerland, 8091
Turkey
Ankara, Turkey, 06100
Edirne, Turkey, 22030
Kocaeli, Turkey, 41380
Ukraine
Chernivtsi, Ukraine, 58000
Dnipropetrovsk, Ukraine, 49027
Dnipropetrovsk, Ukraine, 49044
Kharkiv, Ukraine, 61176
Kharkov, Ukraine, 61068
Kiev, Ukraine, 04107
Kyiv, Ukraine, 03110
Lutsk, Ukraine, 43024
Lviv, Ukraine, 79010
Odesa, Ukraine, 65117
Ternopil, Ukraine, 46027
Vinnytsya, Ukraine, 21018
United Kingdom
Liverpool, United Kingdom, L9 7LJ
London, United Kingdom, E1 2ES
London, United Kingdom, SE5 9RS
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Nottingham, United Kingdom, NG7 2UH
Uruguay
Indianapolis, Uruguay, 46202
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: January 6, 2017

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 January 19, 2017