Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
NCT ID: NCT00928512
Last Updated: 2015-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
237 participants
INTERVENTIONAL
2009-07-31
2011-03-31
Brief Summary
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NCT01350804
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Secukinumab 25mg
Secukinumab 25mg s.c. q4wk
Secukinmab
Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Secukinumab 75mg
Secukinumab 75mg s.c. q4wk
Secukinmab
Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Secukinumab 150mg
Secukinumab 150mg s. c. q4wk
Secukinmab
Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Secukinumab 300mg
Secukinumab 300mg s.c. q4wk
Secukinmab
Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Secukinumab Placebo
Secukinumab Placebo s.c. q4wk
Placebo
Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Interventions
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Secukinmab
Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Placebo
Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At Baseline: Disease activity criteria defined by \> or = 6 out of 28 tender joints and \> or = 6 out of 28 swollen joints WITH either Screening value of hsCRP \> or = 10 mg/L OR ESR \> or = 28 mm/1st hr
Exclusion Criteria
* Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
* Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Mesa, Arizona, United States
Novartis Investigative Site
Peoria, Arizona, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
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Santa Monica, California, United States
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Coeur d'Alene, Idaho, United States
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Springfield, Illinois, United States
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Kalamazoo, Michigan, United States
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Lincoln, Nebraska, United States
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Rochester, New York, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Greenville, South Carolina, United States
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Jackson, Tennessee, United States
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Brussels, , Belgium
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Ostrava, Czech Republic, Czechia
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Pardubice, Czech Republic, Czechia
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Uherské Hradiště, Czech Republic, Czechia
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Prague, , Czechia
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Bayreuth, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hildesheim, , Germany
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München, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Iizuka, Fukuoka, Japan
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Kobe, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Sagamihara, Kanagawa, Japan
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Kurashiki, Okayama-ken, Japan
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Kawagoe, Saitama, Japan
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Bialystok, , Poland
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Bialystok, , Poland
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Lublin, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tula, , Russia
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Tver', , Russia
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Yaroslavl, , Russia
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Košice, Slovak Republic, Slovakia
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Piešťany, Slovak Republic, Slovakia
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Banská Bystrica, , Slovakia
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Busan, Busan, South Korea
Novartis Investigative Site
Anyang-si, Gyeonggi-do, South Korea
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Seoul, Korea, South Korea
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Seoul, , South Korea
Novartis Investigative Site
Niaosong Township, Taiwan, Taiwan
Novartis Investigative Site
Taichung, Taiwan, Taiwan
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Taichung, Taiwan, Taiwan
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Taichung, Taiwan ROC, Taiwan
Novartis Investigative Site
Changhua, , Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Countries
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References
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Genovese MC, Durez P, Richards HB, Supronik J, Dokoupilova E, Aelion JA, Lee SH, Codding CE, Kellner H, Ikawa T, Hugot S, Ligozio G, Mpofu S. One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. J Rheumatol. 2014 Mar;41(3):414-21. doi: 10.3899/jrheum.130637. Epub 2014 Jan 15.
Genovese MC, Durez P, Richards HB, Supronik J, Dokoupilova E, Mazurov V, Aelion JA, Lee SH, Codding CE, Kellner H, Ikawa T, Hugot S, Mpofu S. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis. 2013 Jun;72(6):863-9. doi: 10.1136/annrheumdis-2012-201601. Epub 2012 Jun 23.
Other Identifiers
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2009-011000-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2201
Identifier Type: -
Identifier Source: org_study_id
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