A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
NCT ID: NCT01706926
Last Updated: 2016-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2012-08-31
2014-01-31
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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Placebo
Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram \[mg\] per week) through oral or parenteral route.
Placebo
Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks
Mavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.
Mavrilimumab 150 mg
Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 150 mg
Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.
Interventions
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Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks
Mavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.
Mavrilimumab 150 mg
Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.
Placebo
Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately active disease in line with the protocol
* A pre-defined number of swollen joints in line with the protocol
* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
* No evidence of respiratory disease.
Exclusion Criteria
* A history of, or current, inflammatory joint disease other than RA
* Previous treatment with the investigational drug
* Discontinuation of a biologic DMARD due to lack of efficacy
* Non-compliant concurrent medications
* Non-compliance with medical history criteria.
18 Years
80 Years
ALL
No
Sponsors
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MedImmune Ltd
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Marius Albulescu, MD
Role: STUDY_DIRECTOR
MedImmune Ltd
Locations
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Research Site
Ciudad Autonoma de Buenos Aire, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Santiago, , Chile
Research Site
Viña del Mar, , Chile
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Bruntál, , Czechia
Research Site
Jihlava, , Czechia
Research Site
Ostrava - Trebovice, , Czechia
Research Site
Prague, , Czechia
Research Site
Zlín, , Czechia
Research Site
Tallinn, , Estonia
Research Site
Cologne, , Germany
Research Site
Hildesheim, , Germany
Research Site
Magdeburg, , Germany
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Gdynia, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Barnaul, , Russia
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Belgrade, , Serbia
Research Site
Niška Banja, , Serbia
Research Site
Durban, , South Africa
Research Site
Barcelona, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Donetsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Lutsk, , Ukraine
Research Site
Vinnytsia, , Ukraine
Countries
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References
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Burmester GR, McInnes IB, Kremer J, Miranda P, Korkosz M, Vencovsky J, Rubbert-Roth A, Mysler E, Sleeman MA, Godwood A, Sinibaldi D, Guo X, White WI, Wang B, Wu CY, Ryan PC, Close D, Weinblatt ME; EARTH EXPLORER 1 study investigators. A randomised phase IIb study of mavrilimumab, a novel GM-CSF receptor alpha monoclonal antibody, in the treatment of rheumatoid arthritis. Ann Rheum Dis. 2017 Jun;76(6):1020-1030. doi: 10.1136/annrheumdis-2016-210624. Epub 2017 Feb 17.
Other Identifiers
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CD-IA-CAM-3001-1071
Identifier Type: -
Identifier Source: org_study_id
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