A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01412333
First received: August 8, 2011
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: ocrelizumab Drug: Rebif Drug: ocrelizumab placebo Drug: Rebif placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Annualized protocol-defined relapse rate by 2 years in patients with relapsing MS [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to onset of sustained disability progression for at least 12 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Time to onset of sustained disability progression for at least 24 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Proportion of relapse-free patients [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
- Change in total T2 lesion volume as detected by brain MRI [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
- Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
- Change in brain volume as detected by brain MRI [ Time Frame: from Week 24 to Week 96 ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Immunogenicity: Human anti-human antibodies (HAHA) levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 827 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: ocrelizumab
600 mg iv every 24 weeks (dual infusions of 300 mg on Day 1 and 15 of Cycle 1, single infusion of 600 mg on Day 1 of each following cycle), 96 weeks
Drug: Rebif placebo
Rebif dummy placebo sc according to schedule in Rebif active group B
|
| Active Comparator: B |
Drug: Rebif
8.8 mcg (Weeks 1+2) / 22 mcg (Weeks 3+4) / 44mcg (Week 5 and following) subcutaneously 3 times weekly, 96 weeks
Other Name: Rebif
Drug: ocrelizumab placebo
Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group A
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, 18-55 years of age inclusive
- 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 >/= 30 days prior to both screening and baseline
- Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Exclusion Criteria:
- Primary progressive multiple sclerosis
- Disease duration of more than 10 years in patients with EDSS </= 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
- 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, 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412333
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| United States, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| Phoenix, Arizona, United States, 85050 | |
| Sun City, Arizona, United States, 85351 | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| San Francisco, California, United States, 94143 | |
| Stanford, California, United States, 94305 | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| Ft. Collins, Colorado, United States, 80524 | |
| United States, Connecticut | |
| Derby, Connecticut, United States, 06418 | |
| Fairfield, Connecticut, United States, 06824 | |
| United States, Florida | |
| Bradenton, Florida, United States, 34205 | |
| Hollywood, Florida, United States, 33021 | |
| Maitland, Florida, United States, 32751 | |
| Miami, Florida, United States, 33136 | |
| Orlando, Florida, United States, 32806 | |
| Sarasota, Florida, United States, 34292 | |
| Tampa, Florida, United States, 33613-4706 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Indiana | |
| Ft. Wayne, Indiana, United States, 46805 | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| Lenexa, Kansas, United States, 66214 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40513 | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02135 | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109-0666 | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Golden Valley, Minnesota, United States, 55422 | |
| United States, New Jersey | |
| Freehold, New Jersey, United States, 07728 | |
| Newark, New Jersey, United States, 07103 | |
| Teaneck, New Jersey, United States, 07666 | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| Latham, New York, United States, 12210 | |
| New York, New York, United States, 10065 | |
| Patchogue, New York, United States, 11772 | |
| Plainview, New York, United States, 11803 | |
| Rochester, New York, United States, 14642 | |
| Stony Brook, New York, United States, 11790 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28204 | |
| Hickory, North Carolina, United States, 28602 | |
| Raleigh, North Carolina, United States, 27607-6520 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44320 | |
| United States, Pennsylvania | |
| Abington, Pennsylvania, United States, 19001 | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Greenville, South Carolina, United States, 29607 | |
| United States, Tennessee | |
| Knoxville, Tennessee, United States, 37934 | |
| Memphis, Tennessee, United States, 38120 | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Lubbock, Texas, United States, 79410 | |
| Round Rock, Texas, United States, 78681 | |
| San Antonio, Texas, United States, 78229 | |
| San Antonio, Texas, United States, 78212 | |
| Terrell, Texas, United States, 75160 | |
| United States, Washington | |
| Seattle, Washington, United States, 98122 | |
| Argentina | |
| Buenos Aires, Argentina, C1425BWO | |
| Ciudad Autonoma Bs As, Argentina, 1405 | |
| Ciudad de Buenos Airesa, Argentina, C1013AAB | |
| San Juan, Argentina, 5400 | |
| Belarus | |
| Grodno, Belarus, 230017 | |
| Minsk, Belarus, 220114 | |
| Minsk, Belarus, 220116 | |
| Vitebsk, Belarus, 210032 | |
| Vitebsk, Belarus, 210037 | |
| Belgium | |
| Charleroi, Belgium, 6000 | |
| Edegem, Belgium, 2650 | |
| Kortrijk, Belgium, 8500 | |
| Bosnia and Herzegovina | |
| Sarajevo, Bosnia and Herzegovina, 71 000 | |
| Tuzla, Bosnia and Herzegovina, 75000 | |
| Brazil | |
| Belo Horizonte, MG, Brazil, 30150-221 | |
| Juiz de Fora, MG, Brazil, 36025-330 | |
| Rio de Janeiro, RJ, Brazil, 20270-004 | |
| Campinas, SP, Brazil, 13083-888 | |
| Sao Paulo, SP, Brazil, 05403-000 | |
| Bulgaria | |
| Sofia, Bulgaria, 1309 | |
| Sofia, Bulgaria, 1431 | |
| Sofia, Bulgaria, 1233 | |
| Sofia, Bulgaria, 1113 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Ontario | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Canada, Quebec | |
| Gatineau, Quebec, Canada, J9J 0A5 | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Montréal, Quebec, Canada, H1T 2M4 | |
| Colombia | |
| Bogota, Colombia, 000472 | |
| Croatia | |
| Pula, Croatia, 52100 | |
| Varazdin, Croatia, 42000 | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Brno, Czech Republic, 613 00 | |
| Havirov, Czech Republic, 736 00 | |
| Pardubice, Czech Republic, 532 03 | |
| Praha 4 - Krc, Czech Republic, 140 59 | |
| Teplice, Czech Republic, 415 29 | |
| Zlin, Czech Republic, 762 75 | |
| France | |
| Bron, France, 69677 | |
| Creteil, France, 94010 | |
| Dijon, France, 21033 | |
| Lommé, France, 59462 | |
| Paris, France, 75651 | |
| Poissy, France, 78300 | |
| Reims, France, 51092 | |
| Rennes, France, 35033 | |
| Rouen, France, 76031 | |
| Toulouse, France, 31059 | |
| Germany | |
| Aschaffenburg, Germany, 63739 | |
| Bamberg, Germany, 96049 | |
| Berlin, Germany, 10243 | |
| Berlin, Germany, 12163 | |
| Bonn, Germany, 53117 | |
| Düsseldorf, Germany, 40225 | |
| Essen, Germany, 45122 | |
| Essen, Germany, 45138 | |
| Frankfurt, Germany, 60528 | |
| Grevenbroich, Germany, 41515 | |
| Heidelberg, Germany, 69120 | |
| Köln, Germany, 51109 | |
| Marburg, Germany, 35043 | |
| Minden, Germany, 32429 | |
| Mittweida, Germany, 09648 | |
| Muenchen, Germany, 81377 | |
| München, Germany, 81675 | |
| Siegen, Germany, 57072 | |
| Ulm, Germany, 89078 | |
| Ulm, Germany, 89081 | |
| Ireland | |
| Dublin, Ireland, 4 | |
| Italy | |
| Acquaviva delle Fonti, Italy, 70021 | |
| Bari, Italy, 70124 | |
| Biella, Italy, 13900 | |
| Cefalu, Italy, 90015 | |
| Genova, Italy, 16132 | |
| Milano, Italy, 20133 | |
| Montichiari, Italy, 25018 | |
| Orbassano, Italy, 10043 | |
| Roma, Italy, 00133 | |
| Roma, Italy, 00168 | |
| San Giovanni Rotondo, Italy, 71013 | |
| Torrette - Ancona, Italy, 60100 | |
| Mexico | |
| Aguascalientes, Mexico, 20127 | |
| Chihuahua, Mexico, 31238 | |
| Culiacan, Mexico, 80270 | |
| Culiacan, Mexico, 80020 | |
| Guadalajara, Mexico, 44620 | |
| Mexico, Mexico, 03100 | |
| Monterrey, Mexico, 64710 | |
| Tlalnepantla, Mexico, 54055 | |
| Norway | |
| Bergen, Norway, 5021 | |
| Tønsberg, Norway, 3103 | |
| Poland | |
| Bydgoszcz, Poland, 85-021 | |
| Jaroslaw, Poland, 37-500 | |
| Katowice, Poland, 40-684 | |
| Katowice, Poland, 40-203 | |
| Krakow, Poland, 31-530 | |
| Lodz, Poland, 93-121 | |
| Lodz, Poland, 90-153 | |
| Lublin, Poland, 20-954 | |
| Olsztyn, Poland, 10-561 | |
| Szczecin, Poland, 71-252 | |
| Warszawa, Poland, 02-765 | |
| Russian Federation | |
| Barnaul, Russian Federation, 656024 | |
| Kazan, Russian Federation, 420101 | |
| Kirov, Russian Federation, 610014 | |
| Krasnoyarsk, Russian Federation, 660022 | |
| Nizniy Novgorod, Russian Federation, 603155 | |
| Perm, Russian Federation, 614990 | |
| Pyatigorsk, Russian Federation, 357538 | |
| Saint-Petersburg, Russian Federation, 197022 | |
| Saratov, Russian Federation, 410012 | |
| Yaroslavl, Russian Federation, 150030 | |
| Slovakia | |
| Banska Bystrica, Slovakia, 974 04 | |
| Banska Bystrica, Slovakia, 975 17 | |
| Levoca, Slovakia, 054 01 | |
| Martin, Slovakia, 036 59 | |
| Nove Zamky, Slovakia, 940 34 | |
| Presov, Slovakia, 081 81 | |
| Spain | |
| Badalona, Barcelona, Spain, 08916 | |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Alicante, Spain, 03010 | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08035 | |
| Girona, Spain, 17007 | |
| Madrid, Spain, 28040 | |
| Madrid, Spain, 28007 | |
| Malaga, Spain, 29010 | |
| Valencia, Spain, 46010 | |
| Sweden | |
| Göteborg, Sweden, 413 45 | |
| Stockholm, Sweden, 171 76 | |
| Stockholm, Sweden, 14186 | |
| Umeå, Sweden, 901 85 | |
| Turkey | |
| Ankara, Turkey, 06100 | |
| Istanbul, Turkey, 34394 | |
| Istanbul, Turkey, 34098 | |
| Istanbul, Turkey, 34096 | |
| Istanbul, Turkey, 34668 | |
| Izmir, Turkey, 35100 | |
| Izmir, Turkey, 35340 | |
| Kocaeli, Turkey, 41380 | |
| Samsun, Turkey, 55139 | |
| Trabzon, Turkey, 61080 | |
| Yenisehir-Izmir, Turkey, 35120 | |
| Ukraine | |
| Chernihiv, Ukraine, 14029 | |
| Dnipropetrovsk, Ukraine, 49102 | |
| Donetsk, Ukraine, 83045 | |
| Donetsk, Ukraine, 83114 | |
| Ivano-Frankivsk, Ukraine, 76008 | |
| United Kingdom | |
| Brighton, United Kingdom, BN2 5BE | |
| Exeter, United Kingdom, EX2 5DW | |
| London, United Kingdom, SE5 9RS | |
| Plymouth, United Kingdom, PL6 8BX | |
| Stoke on Trent, United Kingdom, ST4 7NY | |
| Swansea, United Kingdom, SA6 6NL | |
| Truro, United Kingdom, TR1 3LJ | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01412333 History of Changes |
| Other Study ID Numbers: | WA21093 |
| Study First Received: | August 8, 2011 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta |
Interferons Interferon beta 1a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013