A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
NCT ID: NCT02720120
Last Updated: 2016-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
175 participants
INTERVENTIONAL
2005-10-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Ocrelizumab 1000 mg
Participants will receive single IV infusion of ocrelizumab 1000 mg.
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Part 1: Ocrelizumab 1500 mg
Participants will receive single IV infusion of ocrelizumab 1500 mg.
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Part 1: Ocrelizumab 2000 mg
Participants will receive single IV infusion of ocrelizumab 2000 mg.
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Part 1: Ocrelizumab 400 mg
Participants will receive single IV infusion of ocrelizumab 400 milligrams (mg)
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Part 1: Placebo
Participants will receive single IV infusion of placebo matched to ocrelizumab.
Placebo
Participants will receive single IV infusion of placebo.
Part 2: Ocrelizumab 1000 mg
Participants will receive single IV infusion of ocrelizumab 1000 mg.
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Part 2: Ocrelizumab 1500 mg
Participants will receive single IV infusion of ocrelizumab 1500 mg.
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Part 2: Ocrelizumab 400 mg
Participants will receive single IV infusion of ocrelizumab 400 mg.
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Interventions
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Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Placebo
Participants will receive single IV infusion of placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive serum rheumatoid factor (\>/= 20 international units per milliliter)
* Current treatment with RA on an outpatient basis
* Treatment failure with one disease modifying anti-rheumatic drug (DMARD) or biologic, but have not failed more than six of these agents including methotrexate
* Current treatment with methotrexate for at least 12 weeks, at a stable dose
* Use of highly effective contraception.
Exclusion Criteria
* Concurrent treatment with any disease-modifying anti-rheumatic drug (DMARD) (other than methotrexate) or any anti-tumor necrosis factor (TNF) -alfa or other biologic therapy
* Treatment with any other investigational drug within 4 weeks of screening
* Previous treatment with cell-depleting therapies, IV gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening
* Previous treatment with rituximab or any other anti-cluster of differentiation 20 (CD20) agent
* History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies
* Known active bacterial, viral or fungal infections
* History of active tuberculosis and primary or secondary immunodeficiency
* History of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders
* Pregnancy or lactation.
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Darlinghurst, New South Wales, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Ghent, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Amsterdam, , Netherlands
Auckland, , New Zealand
Auckland, , New Zealand
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Cadiz, Cadiz, Spain
Granada, Granada, Spain
Santiago de Compostela, La Coruña, Spain
Alcorcón, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Valencia, Valencia, Spain
Aberdeen, , United Kingdom
Cambridge, , United Kingdom
Derby, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Maidstone, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Norwich, , United Kingdom
Salford, , United Kingdom
Torquay, , United Kingdom
West Midlands, , United Kingdom
Countries
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Other Identifiers
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2004-002132-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA18230
Identifier Type: -
Identifier Source: org_study_id
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