A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
NCT ID: NCT01050998
Last Updated: 2018-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
516 participants
INTERVENTIONAL
2010-01-05
2012-07-27
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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Mavrilimumab 10 mg
Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab 10 mg
Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.
Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.
Mavrilimumab 50 mg
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab 50 mg
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.
Mavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Mavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.
Placebo
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
Placebo
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.
Interventions
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Mavrilimumab 10 mg
Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.
Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.
Mavrilimumab 50 mg
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.
Mavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.
Placebo
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written consent
* Diagnosis of adult onset Rheumatoid Arthritis (RA) of at least 3 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988)
* Treatment with methotrexate at a stable and tolerated doses
* Positive anti-cyclic citrullinated peptide (CCP) immuno-globulin G antibodies (more than \[\>\] 5 international unit per milliliter \[IU/mL\]) and/or rheumatoid factor (RF \>14 IU/mL) at screening
* Received more than or equal to (\>=) 5 milligram (mg) per week folic acid as a single or divided dose during the study.
Exclusion Criteria
* A history of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder
* Subjects at a high risk of infection
* Subjects (male and female) of reproductive potential who are not willing to use contraception from screening through the end date of the trial
* History of methotrexate or any drug-induced lung fibrosis or pneumonitis.
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
Role: STUDY_DIRECTOR
MedImmune Ltd
Locations
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Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Bruntál, , Czechia
Research Site
Ostrava - Trebovice, , Czechia
Research Site
Prague, , Czechia
Research Site
Praha 4 - Nusle, , Czechia
Research Site
Uherské Hradiště, , Czechia
Research Site
Zlín, , Czechia
Research Site
Tallinn, , Estonia
Research Site
Budapest, , Hungary
Research Site
Sopron, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Chiba, , Japan
Research Site
Chiyoda-ku, , Japan
Research Site
Fukui-shi, , Japan
Research Site
Fukuoka, , Japan
Research Site
Goshogawara-shi, , Japan
Research Site
Hamamatsu, , Japan
Research Site
Iizuka-shi, , Japan
Research Site
Kagoshima, , Japan
Research Site
Kasama-shi, , Japan
Research Site
Kitakyushu-shi, , Japan
Research Site
Nagano, , Japan
Research Site
Nagoya, , Japan
Research Site
Okayama, , Japan
Research Site
Omura-shi, , Japan
Research Site
Sagamihara-shi, , Japan
Research Site
Sasebo-shi, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Liepāja, , Latvia
Research Site
Riga, , Latvia
Research Site
Valmiera, , Latvia
Research Site
Klaipėda, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Katowice, , Poland
Research Site
Legnica, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Bucharest, , Romania
Research Site
Ploieşti, , Romania
Research Site
Târgu Mureş, , Romania
Research Site
Barnaul, , Russia
Research Site
Kazan', , Russia
Research Site
Kemerovo, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Donetsk, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Kyiv, , Ukraine
Countries
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References
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Burmester GR, Weinblatt ME, McInnes IB, Porter D, Barbarash O, Vatutin M, Szombati I, Esfandiari E, Sleeman MA, Kane CD, Cavet G, Wang B, Godwood A, Magrini F; EARTH Study Group. Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis. Ann Rheum Dis. 2013 Sep 1;72(9):1445-52. doi: 10.1136/annrheumdis-2012-202450. Epub 2012 Dec 12.
Related Links
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CAM-3001\_CP-219\_Redacted\_4Mar13
Other Identifiers
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MI-CP219
Identifier Type: -
Identifier Source: org_study_id
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