A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
NCT ID: NCT01712399
Last Updated: 2017-06-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
409 participants
INTERVENTIONAL
2013-01-28
2015-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
Interventions
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Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
Eligibility Criteria
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Inclusion Criteria
* No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist
Exclusion Criteria
* Any new conditions or worsening of any pre-existing conditions as defined in the protocol.
19 Years
79 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Ciudad Autonoma Buenos Aires, , Argentina
Research Site
Ciudad Autonoma de Buenos Aire, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Santiago, , Chile
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Viña del Mar, , Chile
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Barranquilla, , Colombia
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Bruntál, , Czechia
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Jihlava, , Czechia
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Ostrava - Trebovice, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Zlín, , Czechia
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Tallinn, , Estonia
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Cologne, , Germany
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Magdeburg, , Germany
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Athens, , Greece
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Larissa, , Greece
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Baja, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Ashkelon, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Mérida, , Mexico
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Gdynia, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Wroclaw, , Poland
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Barnaul, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Belgrade, , Serbia
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Niška Banja, , Serbia
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Bratislava, , Slovakia
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Durban, , South Africa
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Barcelona, , Spain
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Málaga, , Spain
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Santiago de Compostela, , Spain
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Lutsk, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Burmester GR, McInnes IB, Kremer JM, Miranda P, Vencovsky J, Godwood A, Albulescu M, Michaels MA, Guo X, Close D, Weinblatt M. Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor alpha Monoclonal Antibody: Long-Term Safety and Efficacy in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2018 May;70(5):679-689. doi: 10.1002/art.40420. Epub 2018 Mar 31.
Other Identifiers
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Earth Explorer X
Identifier Type: OTHER
Identifier Source: secondary_id
CD-IA-CAM-3001-1109
Identifier Type: -
Identifier Source: org_study_id
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