Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
288 participants
INTERVENTIONAL
2017-01-31
2018-08-27
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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MSB11022
MSB11022
Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
EU-Humira
EU-Humira
Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
Interventions
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MSB11022
Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
EU-Humira
Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline
* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose
Exclusion Criteria
* Evidence of uncontrolled, clinically significant diseases
* Any second disease-modifying antirheumatic drugs must be washed out prior to the first study dose
18 Years
ALL
No
Sponsors
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Fresenius Kabi SwissBioSim GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Fresenius Kabi SwissBioSim GmbH
Locations
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MHAT "Trimontium", OOD
Plovdiv, , Bulgaria
MHAT-Plovdiv AD
Plovdiv, , Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, , Bulgaria
Medical Center "Teodora", EOOD
Rousse, , Bulgaria
MHAT - Ruse, AD
Rousse, , Bulgaria
MHAT - Shumen, AD
Shumen, , Bulgaria
MHAT "Lyulin", EAD
Sofia, , Bulgaria
Medical Center "Excelsior", OOD
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
DCC 17 - Sofia EOOD
Sofia, , Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, , Bulgaria
MC "Synexus - Sofia", EOOD
Sofia, , Bulgaria
Revmatologie Bruntal, s.r.o.
Bruntál, , Czechia
Ccbr-Synarc A/S
Ostrava, , Czechia
A-SHINE s.r.o.
Pilsen, , Czechia
CLINTRIAL s.r.o.
Prague, , Czechia
Revmatologicky Ustav
Prague, , Czechia
Nuselska poliklinika
Prague, , Czechia
Revma Praha, s.r.o.
Prague, , Czechia
Revmatologicka ambulance
Praha 4 Nusle, , Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, , Czechia
PV - Medical, s.r.o.
Zlín, , Czechia
Studienambulanz Dr. Wassenberg
Ratingen, North Rhine-Westphalia, Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, , Germany
Dr. Kenessey Albert Korhaz-Rendelointezet
Balassagyarmat, , Hungary
Revita Reumatologiai Rendelo
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, , Hungary
DRC Szekesfehervar
Székesfehérvár, , Hungary
Mentahaz Maganorvosi Kozpont
Székesfehérvár, , Hungary
Vital Medical Center
Veszprém, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Zalaegerszeg AS
Zalaegerszeg, , Hungary
KLIMED Marek Klimkiewicz
Bialystok, , Poland
ClinicMed Badurski i wspolnicy Spolka Jawna
Bialystok, , Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Malopolskie Centrum Medyczne s.c.
Krakow, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, , Poland
RCMed
Nowy Duninów, , Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
Torun, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
Wroclaw, , Poland
KLIMED Marek Klimkiewicz
Łomża, , Poland
Glasgow Royal Infirmary
Glasgow, Strathclyde, United Kingdom
Whipps Cross University Hospital
London, , United Kingdom
Countries
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References
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Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002852-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200588-0004
Identifier Type: -
Identifier Source: org_study_id