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AzTrials

Relapsing Multiple SclerosisPhase 3NCT01247324

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

A Phase 3 study testing Interferon beta-1a and Ocrelizumab in people with Relapsing Multiple Sclerosis, run by Hoffmann-La Roche at 142 sites in 32 countries.

Completed

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

Official record
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Trial summary

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Interferon beta-1a and Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
821 participants
Where
142 sitesin 32 countries
Study dates
31 Aug 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 multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for greater than or equal to (>=) 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Who cannot join

  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in participants with EDSS less than or equal to (<=) 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Show all 12Show fewer
  • History of or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection (e.g., hepatitis B or C, human immunodeficiency virus [HIV], syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or iv corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use

Trial locations and contacts

142 sites in 32 countries.

142 sites in 32 countries

United States40 sites

  • The MS Center; Advance Neurology and Pain

    Advance, North Carolina, 27006

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Shepherd Center Inc.

    Atlanta, Georgia, 30309

  • Emory University; Department of Neurology

    Atlanta, Georgia, 30322

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30342

  • American Health Network Institute, LLC

    Avon, Indiana, 46123

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Uni of Vermont Medical Center;

    Burlington, Vermont, 05405

  • Mercy Medical Group

    Carmichael, California, 95608

  • Atrium Health Neurosciences Institute ? Charlotte

    Charlotte, North Carolina, 28204

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina, 28277

  • Northwestern University; Dept. of Neurology

    Chicago, Illinois, 60611

  • University Neurology Inc.

    Cincinnati, Ohio, 45219

  • Michigan Neurology Associates P.C.

    Clinton Township, Michigan, 48035

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334

  • The Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Neurology Associates PA

    Hickory, North Carolina, 28602

  • Uni of Texas Health Science Center At Houston

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • MS Center of California

    Laguna Hills, California, 92653

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Bhupesh Dihenia M.D. P.A.

    Lubbock, Texas, 79410

  • Health First Physicians Inc.

    Melbourne, Florida, 32901

  • Mercy Research Institute

    Miami, Florida, 33133

  • Consultants in Neurology Ltd

    Northbrook, Illinois, 60062

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-0600

  • Neuro-Therapeutics Inc.

    Pasadena, California, 91105

  • Albert Einstein Medical Center; Depatment of Neurosensory sciences

    Philadelphia, Pennsylvania, 19141

  • 21st Century Neurology

    Phoenix, Arizona, 85004

  • Magee-Woman's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Providence Neurological Specialties

    Portland, Oregon, 97225

  • University of California at San Francisco

    San Francisco, California, 94115

  • Miami Research Associates

    South Miami, Florida, 33143

  • Washington University; Wash Uni. Sch. Of Med

    St Louis, Missouri, 63110

  • The MS Center for Innovations In Care

    St Louis, Missouri, 63131

  • Multicare Research Institute; Multicare Neuroscience Center of Washington

    Tacoma, Washington, 98405

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

Russia12 sites

  • Kemerovo Regional Clinical Hospital

    Kemerovo, 650066

  • Central Clinical Hospital #2 N.A. Semashko OAO RJHD

    Moskva, Moscow Oblast, 107150

  • FGBU FNKC FMBA of Russia

    Moskva, Moscow Oblast, 115682

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk, 630007

  • MRC for Oncology and Neurology Biotherapy

    Novosibirsk, 630090

  • MMA of Ministry of Defense of Russia named after S.M. Kirov

    Saint Petersburg, Sankt-Peterburg, 194044

  • St.-Peterburg State institution of health care City multifield hospital #2

    Saint Petersburg, Sankt-Peterburg, 194354

  • Samara State Medical University

    Samara, 443099

  • Reg. SI of Health Care Smolensk Regional Clinical Hospital

    Smolensk, 214018

  • Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"

    Tyumen, Tyumen Oblast, 625000

  • Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"

    Tyumen, 625000

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

Germany10 sites

  • Charité Universitaetsmedizin Berlin, Campus Charité Mitte

    Berlin, 10117

  • Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden

    Dresden, 01307

  • Asklepiosklinik Barmbek; Abteilung Neurologie

    Hamburg, 22291

  • Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie

    Hanover, 30171

  • Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

    Mainz, 55131

  • Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie

    Oldenburg, 26122

  • Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune

    Prien am Chiemsee, 83209

  • Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie

    Rostock, 18147

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655

Other trials in Germany

Czechia6 sites

  • Fakultni nemocnice u sv. Anny; Neurologicka klinika

    Brno, 656 91

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Nemocnice Jihlava; NEU-Neurologicke oddeleni

    Jihlava, 58633

  • Krajska Nemocnice Pardubice Neurologicka Klinika

    Pardubice, 532 03

  • VFN Praha Poliklinika Rs Centrum - Budova A

    Prague, 12808

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

    Teplice, 415 29

Other trials in Czechia

Bulgaria5 sites

  • MHAT Avis Medica; Neurology Department

    Pleven, 5800

  • First MHAT; Clinic of Neurology

    Sofia, 1000

  • MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders

    Sofia, 1113

  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

    Sofia, 1407

  • Military Medical Academy; Neurology

    Sofia, 1606

Other trials in Bulgaria

France5 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000

  • CHU Hopital Gabriel Montpied; Service de Neurologie

    Clermont-Ferrand, 63003

  • Hopital Central; Neurologie

    Nancy, 54035

  • CHU de Nîmes Hopital Caremeau; Service de Neurologie

    Nîmes, 30900

  • Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

    Strasbourg, 67098

Other trials in France

Ukraine5 sites

  • MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics

    Donetsk, 83099

  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

    Kharkiv, 61068

  • Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology

    Kyiv, 03110

  • Lviv Regional Clinical Hospital; Department of Neurology

    Lviv, 79010

  • Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

    Vinnytsia, 21005

Other trials in Ukraine

Italy4 sites

  • Azienda Socio Sanitaria Territoriale della Valle Olona (pres

    Gallarate, Aosta Valley, 21013

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Azienda Ospedaliera di Padova; Clinica Neurologica

    Padova, Veneto, 35128

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189

Other trials in Italy

Peru4 sites

  • Policlinico Especializado en Neurologia

    Callao, 04

  • Clinica Anglo Americana

    Lima, 18

  • Hospital Nacional Dos de Mayo

    Lima

  • Clinica Centenario Peruano Japonesa; Neurology

    Pueblo Libre, Lima 21

Other trials in Peru

Poland4 sites

  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

    Gdansk, 80-803

  • Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

    Katowice, 40-588

  • MA-LEK Clinical Sp. Z o.o.

    Katowice, 40-595

  • Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

    Plewiska, 62-064

Other trials in Poland

Slovakia4 sites

  • FNsP Bratislava - Nemocnica Stare mesto

    Bratislava, 813 69

  • FNsP Bratislava, Nemocnica Ruzinov

    Bratislava, 826 06

  • Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren

    Bratislava, 851 07

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 012 07

Other trials in Slovakia

Spain4 sites

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología

    Madrid, 28222

  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

    Santa Cruz de Tenerife, Tenerife, 38010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Argentina3 sites

  • Instituto centenario

    Buenos Aires, C1204AAD

  • Hospital Español

    Ciudad Autonoma Bs As, C1209AAB

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, S2000BZL

Other trials in Argentina

Belgium3 sites

  • AZ Sint Jan

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc; Neurology

    Brussels, 1200

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

Other trials in Belgium

Brazil3 sites

  • Hospital das Clinicas - UFG;Reumatologia

    Goiânia, Goiás, 74653-050

  • Clinica Neurologica; Neurocirurgica de Joinville

    Joinville, Santa Catarina, 89202-190

  • IMV Pesquisa Neurológica

    Porto Alegre, Rio Grande do Sul, 90110-000

Other trials in Brazil

Hungary3 sites

  • Semmelweis Egyetem AOK; Neurologiai Klinika

    Budapest, 1083

  • Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti

    Budapest, 1204

  • Szent Borbala Korhaz; Neurology

    Tatabánya, 2800

Other trials in Hungary

Lithuania3 sites

  • Kaunas Medical University Hospital

    Kaunas, 50009

  • Klaipeda University Hospital Public Institution

    Klaipėda, 92288

  • Vilnius University Hospital Santariskiu Clinic

    Vilnius, 08661

Other trials in Lithuania

Serbia3 sites

  • Military Medical Academy

    Belgrade, 11040

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Tunisia3 sites

  • Hopital Razi

    Mannouba, 2010

  • Hopital Universitaire Fattouma Bourguiba

    Monastir, 5000

  • Hopital Charles Nicolle

    Tunis, 1006

Other trials in Tunisia

Estonia2 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Latvia2 sites

  • Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology

    Riga, 1015

  • P. Stradins Clinical University Hospital; Neurology

    Riga, LV-1002

Other trials in Latvia

Mexico2 sites

  • Grupo Médico Camino S.C.

    Mexico City, Mexico CITY (federal District), 03600

  • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Switzerland2 sites

  • Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

    Basel, 4031

  • Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia

    Lugano, 6900

Other trials in Switzerland

United Kingdom2 sites

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

    Liverpool, L9 7LJ

  • Royal London Hospital; Neurology

    London, E1 1BD

Other trials in United Kingdom

Australia1 site

  • Royal North Shore Hospital; Department of Neurology

    St Leonards, New South Wales, 2065

Other trials in Australia

Austria1 site

  • Barmherzige Brueder Konventspital

    Linz, 4040

Other trials in Austria

Chile1 site

  • Hospital Carlos Van Buren

    Valparaíso, 2340000

Other trials in Chile

Finland1 site

  • FinnMedi Oy

    Tampere, 33520

Other trials in Finland

Israel1 site

  • Chaim Sheba Medical Center; Neurology Department

    Ramat Gan, 5262000

Other trials in Israel

Netherlands1 site

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

Other trials in Netherlands

Portugal1 site

  • Hospital de Braga; Servico de Neurologia

    Braga, 4710-243

Other trials in Portugal

South Africa1 site

  • Dr CC Coetzee Inc

    Durban, 4319

Other trials in South Africa

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

Being tested
Interferon beta-1a, Ocrelizumab-matching placebo, Ocrelizumab, Interferon beta-1a-matching placebo

What participants receive

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

  • Interferon beta-1aDrug

    Also called Rebif

  • Ocrelizumab-matching placeboDrug

  • OcrelizumabDrug

    Also called RO4964913

  • Interferon beta-1a-matching placeboDrug

Study groups in NCT01247324
Study groupRoleWhat they receive
Interferon beta-1a 44 mcg SCActive comparatorInterferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Receives: Drug: Interferon beta-1a; Drug: Ocrelizumab-matching placebo
OcrelizumabExperimentalOcrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
Receives: Drug: Ocrelizumab; Drug: Interferon beta-1a-matching placebo

What is being measured

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

  1. Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks

    ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.

    Measured: Week 96

Secondary outcomes (13)

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

    Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.

    Measured: Week 108

  2. Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment

    The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.

    Measured: Baseline up to Week 96

  3. Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment

    The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.

    Measured: Baseline up to Week 96

  4. Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks

    Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.

    Measured: Week 96

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

    Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.

    Measured: Week 108

  6. Number of T1 Hypointense Lesions During the Double-Blind Treatment

    The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.

    Measured: Baseline up to Week 96

  7. Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96

    MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.

    Measured: Baseline, Week 96

  8. Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96

    Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week.

    Measured: From Week 24 up to Week 96

  9. Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96

    The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.

    Measured: Baseline, Week 96

  10. Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96

    NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.

    Measured: Week 96

  11. Number of Participants With Adverse Events (AEs)

    AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.

    Measured: Baseline up to 588 weeks

  12. Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)

    AUC represents total drug exposure for one dosing interval after the 4th dose.

    Measured: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96

  13. Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab

    Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.

    Measured: Baseline up to week 96

Timeline

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

  1. First posted24 Nov 2010 (estimated)
  2. Study start31 Aug 2011
  3. Primary completion2 Apr 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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
821 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01247324
Sponsor's protocol ID
WA21092
Other IDs
2010-020337-99
Status last verified
Feb 2024
First submitted
23 Nov 2010
Last updated
4 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hauser SL, Bar-Or A, Giovannoni G, Montalban X, Lebrun-Frenay C, Amezcua L, Villar LM, Arnold DL, Weber MS, Filippi M, Pasquarelli N, Chognot C, Wang Q, Schneble HM, Craveiro L, Kappos L. Ten Years of Ocrelizumab in Relapsing Multiple Sclerosis: The OPERA I and II Randomized Clinical Trials. JAMA Neurol. 2026 Oct 5. doi: 10.1001/jamaneurol.2026.3507. Online ahead of print.

    PubMed 42832215

  • Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8.

    PubMed 40629721

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon beta-1a and Ocrelizumab in people with Relapsing Multiple Sclerosis, run by Hoffmann-La Roche at 142 sites in 32 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 12 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Russia, Germany, Czechia, Bulgaria and 27 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. 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 18 Jul 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?

Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (time frame: Week 96). 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 NCT01247324, which also lists 17 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 4 Mar 2024.

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