Clinical trial NCT03052322: MSB11022 in Moderate to Severe Rheumatoid Arthritis
Official title: A Multicenter, Randomized, Double-blind, Phase III Trial to Evaluate the Safety, Immunogenicity, and Efficacy of MSB11022 Compared With Humira® in Patients With Moderately to Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Rheumatoid Arthritis
Lead sponsor: Fresenius Kabi SwissBioSim GmbH
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult participants with rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis based on 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 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
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Evidence of untreated or inadequately treated latent or active Tuberculosis
* Evidence of uncontrolled, clinically significant diseases
* Any second disease-modifying antirheumatic drugs must be washed out prior to the first study dose
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) Status to Adalimumab
timeFrame: Baseline, Week 2, 4, 12, 24, 36 and 52
measure: Anti-Drug Antibodies (ADAs) Titer Levels for Adalimumab
timeFrame: Baseline, Week 2, 4, 12, 24, 36 and 52
measure: Percentage of Participants With Confirmed Neutralizing Antibodies (NAb) Status to Adalimumab
timeFrame: Baseline, Week 2, 4, 12, 24, 36 and 52
measure: Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 2, 4, 8, 24 and 52
timeFrame: Week 2, 4, 8, 24 and 52
measure: Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Response at Week 2, 4, 8, 12, 24 and 52
timeFrame: Week 2, 4, 8, 12, 24 and 52
measure: Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Response at Week 2, 4, 8, 12, 24 and 52
timeFrame: Week 2, 4, 8, 12, 24 and 52
measure: Change From Baseline in Disease Activity Score Based on a 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 2, 4, 8, 12, 24 and 52
timeFrame: Baseline, Week 2, 4, 8, 12, 24 and 52
measure: Percentage of Participants With Disease Activity Score Based on 28-joints Count- Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity and Remission at Week 2, 4, 8, 12, 24, and 52
timeFrame: Week 2, 4, 8, 12, 24, and 52
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Total Score at Week 2, 4, 8, 12, 24, and 52
timeFrame: Baseline, Week 2, 4, 8, 12, 24, and 52
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Total Score at Week 2, 4, 8, 12, 24 and 52
timeFrame: Baseline, Week 2, 4, 8, 12, 24 and 52
measure: Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission at Week 2, 4, 8, 12, 24 and 52
timeFrame: Week 2, 4, 8, 12, 24 and 52
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
timeFrame: Baseline up to Week 69
measure: Percentage of Participants With Clinically Meaningful Differences in Vital Signs
timeFrame: Up to Week 52
measure: Percentage of Participants With Clinically Meaningful Differences in Laboratory Values
timeFrame: Up to Week 52
measure: Percentage of Participants With Clinically Significant Abnormal Values for 12-lead Electrocardiogram (ECG) at Week 12, 24, and 52
timeFrame: Week 12, 24, and 52
measure: Percentage of Participants With Anti-Nuclear Antibody (ANA) and Anti Double-stranded Deoxyribonucleic Acid (Anti-dsDNA) at Baseline, Week 24 and 52
timeFrame: Baseline, Week 24 and 52
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 12, 24 and 52
timeFrame: Baseline, Weeks 12, 24 and 52
measure: Short-Form Health Survey- 36 Items (SF-36) at Baseline, Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24 and 52
measure: Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Utility Index Score at Baseline, Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24 and 52
measure: Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Baseline, Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24 and 52
measure: Mean Change From Baseline (Week 4) in Injection Site Pain as Assessed by Visual Analogue Scale (VAS) at Week 6 and 8
timeFrame: Immediately, 15 minutes and 1 hour post-injection on Baseline (Week 4), Week 6 and 8
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: MHAT "Trimontium", OOD
city: Plovdiv
country: Bulgaria
facility: MHAT-Plovdiv AD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", EOOD
city: Ruse
country: Bulgaria
facility: Medical Center "Teodora", EOOD
city: Ruse
country: Bulgaria
facility: MHAT - Ruse, AD
city: Shumen
country: Bulgaria
facility: MHAT - Shumen, AD
city: Sofia
country: Bulgaria
facility: MHAT "Lyulin", EAD
city: Sofia
country: Bulgaria
facility: Medical Center "Excelsior", OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: DCC 17 - Sofia EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: MC "Synexus - Sofia", EOOD
city: Bruntal
country: Czechia
facility: Revmatologie Bruntal, s.r.o.
city: Ostrava
country: Czechia
facility: Ccbr-Synarc A/S
city: Plzen
country: Czechia
facility: A-SHINE s.r.o.
city: Praha 10
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha 13
country: Czechia
facility: Revma Praha, s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky Ustav
city: Praha 4 Nusle
country: Czechia
facility: Revmatologicka ambulance
city: Praha 4
country: Czechia
facility: Nuselska poliklinika
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Zlin
country: Czechia
facility: PV - Medical, s.r.o.
city: Ratingen
country: Germany
facility: Studienambulanz Dr. Wassenberg
state: Nordrhein Westfalen
city: Hamburg
country: Germany
facility: HRF Hamburger Rheuma Forschungszentrum
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz-Rendelointezet
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Szekesfehervar
country: Hungary
facility: DRC Szekesfehervar
city: Szekesfehervar
country: Hungary
facility: Mentahaz Maganorvosi Kozpont
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Zalaegerszeg AS
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy Spolka Jawna
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne s.c.
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
city: Lomza
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Nowy Duninow
country: Poland
facility: RCMed
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Klinicznych
city: Torun
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Wroclaw
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Strathclyde
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
Study officials:
affiliation: Fresenius Kabi SwissBioSim GmbH
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.