AzTrials
AzTrials

Multiple Sclerosis, Primary ProgressivePhase 3NCT01194570

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, Primary Progressive, run by Hoffmann-La Roche at 184 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Primary Progressive
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
735 participants
Where
184 sitesin 29 countries
Study dates
2 Mar 2011to 31 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

184 sites in 29 countries.

184 sites in 29 countries

United States37 sites

  • University of New Mexico; MS Specialty Clinic

    Albuquerque, New Mexico, 87131

  • University of Colorado; Anschutz Medical Campus Department of Neurology

    Aurora, Colorado, 80045

  • Sutter East Bay Medical Foundation

    Berkeley, California, 94705

  • Carolinas Medical Center; Ms Center

    Charlotte, North Carolina, 28207

  • The Ohio State University Wexner Medical Center; Department of Neurology

    Columbus, Ohio, 43221

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • University of Texas Southwestern

    Dallas, Texas, 75390-8897

  • Wayne State University; Department of Neurology

    Detroit, Michigan, 48201

  • Henry Ford Health System; Neurology & Neurosurgery

    Detroit, Michigan, 48202

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334

  • Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

    Houston, Texas, 77030

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501

  • University of Minnesota; Clin. Neuro Research Unit

    Minneapolis, Minnesota, 55414

  • Weill Medical College of Cornell University; Judith Jaffe MS Ctr

    New York, New York, 10021

  • Mount Sinai School of Medicine; Neurology

    New York, New York, 10029

  • MS Center of Southern California

    Newport Beach, California, 92663

  • Oklahoma Medical Research Foundation; MS Center of Excellence

    Oklahoma City, Oklahoma, 73104

  • Comprehensive MS Care Center at South Shore Neurologic Assoc.

    Patchogue, New York, 11772

  • Trustees of the University of Pennsylvania; Neurology

    Philadelphia, Pennsylvania, 19104

  • Phoenix Neurological Associates Ltd

    Phoenix, Arizona, 85006

  • Barrow Neurology Clinic

    Phoenix, Arizona, 85013

  • Arizona Neuroscience Research LLC

    Phoenix, Arkansas, 85032-2181

  • MidAmerica Neuroscience Institute

    Prairie Village, Kansas, 66206

  • The Neurology Foundation, Inc.

    Providence, Rhode Island, 02905

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520

  • Neurological Associates, Inc.

    Richmond, Virginia, 23229

  • Univ of CA Davis Med Ctr; Neurology

    Sacramento, California, 95817

  • Univ of CA San Francisco; Department of Neurology

    San Francisco, California, 94143

  • Mayo Clinic- Scottsdale

    Scottsdale, Arizona, 85259

  • Swedish Neuroscience Institute; Multiple Sclerosis Center

    Seattle, Washington, 98122

  • Washington University School of Medicine; Department of Neurology

    St Louis, Missouri, 63110

  • Neurology Assoc of Stony Brook

    Stony Brook, New York, 11794

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Vero Beach Neurology and Research Institute

    Vero Beach, Florida, 32960

Other trials in United States

Germany18 sites

  • Klinikum Bayreuth GmbH; Neurologische Klinik

    Bayreuth, 95445

  • Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

    Berg, 82335

  • Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

    Berlin, 10117

  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

    Berlin, 13347

  • Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

    Bochum, 44789

  • Kliniken der Stadt Koln gGmbH

    Cologne, 51109

  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie

    Dresden, 01307

  • Heinrich Heine Universität Düsseldorf; Neurologische Klinik

    Düsseldorf, 40225

  • Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

    Frankfurt am Main, 60528

  • Universitätsklinikum Gießen und Marburg GmbH; Neurologie

    Giessen, 35392

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

    Leipzig, 04103

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitatsklinikum Munster

    Münster, 48149

  • Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie

    Regensburg, 93053

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076

  • Universitätsklinikum Ulm; Klinik für Neurologie

    Ulm, 89081

  • DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)

    Wiesbaden, 65191

Other trials in Germany

France17 sites

  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B

    Bordeaux, 33076

  • Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

    Bron, 69677

  • Hopital Cote De Nacre; Unite Neurologie Generale

    Caen, 14033

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

    Clermont-Ferrand, 63003

  • Hopital Roger Salengro Service de Neurologie

    Lille

  • CHU de la Timone - Hopital d Adultes; Service de Neurologie

    Marseille, 13005

  • Hopital Gui de Chauliac; Neurologie

    Montpellier, 34295

  • CHRU Nancy; Service de neurologie

    Nancy, 54035

  • Hôpital Guillaume et René Laënnec; Service Neurologie

    Nantes, 44805

  • Hôpital Pasteur; Service de Neurologie

    Nice, 06002

  • Groupe Hospitalo-Universitaire Caremeau; Service Neurologie

    Nîmes, 30029

  • Fondation Rothschild; Service de Neurologie

    Paris, 75019

  • Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

    Paris, 75651

  • Hôpital de Poissy; Service neurologie

    Poissy, 78300

  • Hôpital Maison Blanche; Service de Neurologie

    Reims, 51092

  • Chu De Strasbourg; Hopital Civil

    Strasbourg, 67091

  • Hopital Purpan; Fédération de neurologie

    Toulouse, 31059

Other trials in France

Spain14 sites

  • Hospital General Univ. de Alicante

    Alicante, 03010

  • Hospital del Mar; Servicio de Neurologia

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

    Barcelona, 08035

  • Hospital Clinic i Provincial; Servicio de Neurologia

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

    Barcelona, 08041

  • Hospital de Basurto Servicio de Neurologia

    Bilbao, Vizcaya, 48013

  • Hospital Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Universitario de La Princesa; Servicio de Neurología

    Madrid, 28006

  • Hospital Ramon y Cajal; Servicio de Neurologia

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos; Servicio de Neurología

    Madrid, 28040

  • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

    Málaga, 29010

  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

    Salt, Girona, 17190

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen Macarena; Servicio de Neurologia

    Seville, 41009

Other trials in Spain

Ukraine11 sites

  • CNPE City Clinical Hospital #3 of Chernivtsi City Council

    Chernivtsi, Chernihiv Governorate, 58022

  • Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro

    Dnipropetrovsk, 49027

  • Dnipropetrovsk State Medical Academy; Dept of Neurology

    Dnipropetrovsk, 49044

  • Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

    Kharkiv, 61068

  • Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology

    Kharkiv, 61176

  • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, KIEV Governorate, 04107

  • Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology

    Kyiv, 03110

  • Volyn Regional Clinical Hospital

    Lutsk, 43024

  • Lviv Regional Clinical Hospital; Department of Neurology

    Lviv, 79010

  • Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

    Odesa, Kherson Governorate, 65025

  • Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3

    Vinnytsia, 21018

Other trials in Ukraine

Canada7 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • St. Michael'S Hospital

    Toronto, Ontario, M5B 1W8

  • University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver

    Vancouver, British Columbia, V6T 1Z3

  • Health Sciences Centre

    Winnipeg, Manitoba, R8A 1R9

Other trials in Canada

Poland7 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna

    Bialystok, 15-402

  • Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny

    Gmina Końskie, 26-200

  • Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna

    Jarosław, 37-500

  • Diagnomed Clinical Research Sp. z o.o.

    Katowice, 40-594

  • Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic

    Katowice, 40-686

  • SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii

    Lodz, 90-153

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

    Lublin, 20-954

Other trials in Poland

Hungary6 sites

  • Fövárosi Önkormányzat uzsoki utcai Kórház

    Budapest, 1145

  • Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

    Budapest, 1204

  • Vaszary Kolos Korhaz; Neurology

    Esztergom, 2500

  • Pécsi Tudományegyetem

    Pécs, 7623

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

    Szeged, 6725

  • Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia

    Veszprém, 8200

Other trials in Hungary

Israel6 sites

  • Barzilai Medical Center; Neurology Department

    Ashkelon, 7830604

  • Hadassah University Hospital Ein Kerem; Neurology Department

    Jerusalem, 9112001

  • Rabin Medical Center; Multiple Sclerosis Clinic

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center; Multiple Sclerosis Center

    Ramat Gan, 5262100

  • Medical Center Ziv Safed; Neurology Department

    Safed, 13100

  • Tel Aviv Sourasky Medical Center; Department of Neurology

    Tel Aviv, 6423906

Other trials in Israel

Portugal6 sites

  • Hospital Garcia de Orta; Servico de Neurologia

    Almada, 2801-951

  • Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

    Amadora, 2720-276

  • HUC; Servico de Neurologia

    Coimbra, 3000-075

  • Hospital Geral; Servico de Neurologia

    Coimbra, 3041-801

  • Hospital de Santa Maria; Servico de Neurologia

    Lisbon, 1649-035

  • Hospital Geral de Santo Antonio; Servico de Neurologia

    Porto, 4099-001

Other trials in Portugal

Austria5 sites

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

    Innsbruck, 6020

  • Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

    Linz, 4020

  • Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie

    Linz, 4021

  • Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

    Salzburg, 5020

  • Medizinische Universitat Wien Medical University of Vienna

    Vienna, 1090

Other trials in Austria

United Kingdom5 sites

  • Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

    Liverpool, L9 7LJ

  • Barts and the London NHS Trust

    London, E1 2ES

  • Kings College Hospital; Neurology

    London, SE5 9RS

  • Royal Victoria Infirmary; Neurology Dept.

    Newcastle upon Tyne, NE1 4LP

  • Uni Hospital Queens Medical Centre; Neurology

    Nottingham, NG7 2UH

Other trials in United Kingdom

Brazil4 sites

  • Santa Casa de Misericordia; de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital das Clinicas - UFG;Reumatologia

    Goiânia, Goiás, 74653-050

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Universitario Clementino Fraga Filho - UFRJ

    Rio de Janeiro, Rio de Janeiro, 21941-913

Other trials in Brazil

Italy4 sites

  • Ospedale Binaghi; Centro Sclerosi Multipla

    Cagliari, Sardinia, 09126

  • A.O. Universitaria S. Martino Di Genova

    Genoa, Liguria, 16132

  • Hospital San Raffaele

    Milan, Lombardy, 20132

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

    Orbassano, Piedmont, 10043

Other trials in Italy

Mexico4 sites

  • Instituto Biomedico De Investigacion A.C.

    Aguascalientes, 20127

  • Eleccion Salud SC

    México, Mexico CITY (federal District), 3600

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, Mexico CITY (federal District), 14390

  • Centro de Estudios Clinicos y Espec. Med. SC

    Monterrey, Nuevo León, 64620

Other trials in Mexico

Romania4 sites

  • Elias Emergency University Hospital Neurology Dept; Neurology Department

    Bucharest, 011461

  • SC Clubul Sanatatii SRL

    Campulung Muscel, 115100

  • Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

    Târgu Mureş, 540136

  • Timisoara Emergency County Clinical Hospital

    Timi?oara, 300595

Other trials in Romania

Czechia3 sites

  • Fakultni nemocnice Brno; Interni kardiologicka klinika

    Brno, 625 00

  • Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika

    Prague, 128 08

  • Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni

    Teplice, 415 29

Other trials in Czechia

Finland3 sites

  • Helsingin yliopistollinen keskussairaala

    Helsinki, 00290

  • Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö

    Tampere, 33520

  • Turku University Central Hospital; Pharmacy

    Turku, 20520

Other trials in Finland

Greece3 sites

  • 401 Military Hospital of Athens; Neurology Department

    Athens, 115 25

  • AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

    Thessaloniki, 546 36

  • Georgios Papanikolaou General Hosp. of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

Lithuania3 sites

  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

    Kaunas, 50009

  • Klaipeda University Hospital Public Institution

    Klaipėda, 92288

  • Siauliai Hospital

    Šiauliai, 76231

Other trials in Lithuania

Peru3 sites

  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

    Bellavista, Callao 2

  • Clinica Anglo Americana

    Lima, 18

  • Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología

    Lima, Lima 1

Other trials in Peru

Australia2 sites

  • St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research

    Fitzroy, Victoria, 3065

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

Other trials in Australia

Belgium2 sites

  • CHU Tivoli

    La Louvière, 7100

  • AZ Alma vzw (Sijsele)

    Sijsele, 8340

Other trials in Belgium

Bulgaria2 sites

  • Shat Np Sveti Naum; 3Rd Clinic of Neurology

    Sofia, 1113

  • Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

    Sofia, 1309

Other trials in Bulgaria

Netherlands2 sites

  • Erasmus MC; Afdeling Neurologie

    Rotterdam, 3015 GD

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

New Zealand2 sites

  • Waikato Hospital; Neurology

    Hamilton, 3240

  • Wellington Hospital; Department of Neurology

    Wellington, 6021

Other trials in New Zealand

Switzerland2 sites

  • Universitätsspital Basel; Neurologie

    Basel, 4031

  • Ospedale Regionale di Lugano - Civico; Neurologia

    Lugano, 6903

Other trials in Switzerland

Norway1 site

  • Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling

    Oslo, 0407

Other trials in Norway

Russia1 site

  • Research Medical Complex "Vashe Zdorovie"; Neurology Department

    Kazan', Tatarstan Republic, 420103

Other trials in Russia

About this study

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

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.

Being tested
Ocrelizumab, Placebo
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    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.

  • PlaceboOther

    Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.

Study groups in NCT01194570
Study groupRoleWhat they receive
PlaceboExperimentalParticipants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Receives: Drug: Ocrelizumab; Other: Placebo
Ocrelizumab 600 mgPlacebo comparatorParticipants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period

    The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.

    Measured: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

Secondary outcomes (6)

  1. Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period

    The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.

    Measured: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

  2. Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120

    Measured: Baseline, Week 120

  3. Percent Change From Baseline in Total Volume of T2 Lesions at Week 120

    Measured: From Baseline to Week 120

  4. Percent Change in Total Brain Volume From Week 24 to Week 120

    Measured: From Week 24 to Week 120

  5. Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120

    The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0-100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: From Baseline to Week 120

  6. Number of Participants With at Least One Adverse Event (AE)

    AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.

    Measured: From baseline to 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2010 (estimated)
  2. Study start2 Mar 2011
  3. Primary completion23 Jul 2015
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01194570
Sponsor's protocol ID
WA25046
Other IDs
2010-020338-25
Status last verified
Dec 2023
First submitted
28 Aug 2010
Last updated
10 Jan 2024
Data monitoring committee
Yes
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.

    PubMed 40258203

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, Primary Progressive, run by Hoffmann-La Roche at 184 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Germany, France, Spain, Ukraine and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (time frame: Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01194570, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

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