MSB11022 in Moderate to Severe Rheumatoid Arthritis

NCT03052322 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MS200588-00042016-002852-26
• Study Type: interventional
• Target: 288
• Locations: 6 countries
• Sites: 46

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).

Conditions

Moderate to Severe Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)

  Adverse event (AE) was defined as any untoward medical occurrence in participants, which does not necessarily have causal relationship with treatment. Term Treatment-emergent Adverse Events (TEAE) is defined as AEs starting/worsening after first intake of the study drug. Hypersensitivity was the pre-defined TEAE of special Interest for this study. The percentage of participants with treatment emergent AESIs (hypersensitivity) were reported.

  Up to Week 52

Secondary Outcomes (22)

• Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 12

  Week 12

• Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) Status to Adalimumab

  Baseline, Week 2, 4, 12, 24, 36 and 52

• Anti-Drug Antibodies (ADAs) Titer Levels for Adalimumab

  Baseline, Week 2, 4, 12, 24, 36 and 52

• Percentage of Participants With Confirmed Neutralizing Antibodies (NAb) Status to Adalimumab

  Baseline, Week 2, 4, 12, 24, 36 and 52

• Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 2, 4, 8, 24 and 52

  Week 2, 4, 8, 24 and 52

Study Arms (2)

MSB11022

EXPERIMENTAL

Drug: MSB11022

EU-Humira

ACTIVE COMPARATOR

Drug: EU-Humira

Interventions

MSB11022 DRUG

Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.

Also known as: Adalimumab

MSB11022

EU-Humira DRUG

Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.

EU-Humira

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi SwissBioSim GmbH: lead

Study Sites (46)

MHAT "Trimontium", OOD

Plovdiv, 4000, Bulgaria

Location

MHAT-Plovdiv AD

Plovdiv, 4002, Bulgaria

Location

UMHAT "Kaspela", EOOD

Plovdiv, 4002, Bulgaria

Location

Medical Center "Teodora", EOOD

Rousse, 7000, Bulgaria

Location

MHAT - Ruse, AD

Rousse, 7002, Bulgaria

Location

MHAT - Shumen, AD

Shumen, 9700, Bulgaria

Location

MHAT "Lyulin", EAD

Sofia, 1336, Bulgaria

Location

Medical Center "Excelsior", OOD

Sofia, 1407, Bulgaria

Location

UMHAT "Sv. Ivan Rilski", EAD

Sofia, 1431, Bulgaria

Location

DCC 17 - Sofia EOOD

Sofia, 1504, Bulgaria

Location

Military Medical Academy - MHAT - Sofia

Sofia, 1606, Bulgaria

Location

MC "Synexus - Sofia", EOOD

Sofia, 1784, Bulgaria

Location

Revmatologie Bruntal, s.r.o.

Bruntál, 792 01, Czechia

Location

Ccbr-Synarc A/S

Ostrava, 702 00, Czechia

Location

A-SHINE s.r.o.

Pilsen, 31200, Czechia

Location

CLINTRIAL s.r.o.

Prague, 100 00, Czechia

Location

Revmatologicky Ustav

Prague, 128 50, Czechia

Location

Nuselska poliklinika

Prague, 140 00, Czechia

Location

Revma Praha, s.r.o.

Prague, 158 00, Czechia

Location

Revmatologicka ambulance

Praha 4 Nusle, 140 00, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, 686 01, Czechia

Location

PV - Medical, s.r.o.

Zlín, 760 01, Czechia

Location

Studienambulanz Dr. Wassenberg

Ratingen, North Rhine-Westphalia, 40882, Germany

Location

HRF Hamburger Rheuma Forschungszentrum

Hamburg, 20095, Germany

Location

Dr. Kenessey Albert Korhaz-Rendelointezet

Balassagyarmat, 2660, Hungary

Location

Revita Reumatologiai Rendelo

Budapest, 1023, Hungary

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 1036, Hungary

Location

DRC Szekesfehervar

Székesfehérvár, 8000, Hungary

Location

Mentahaz Maganorvosi Kozpont

Székesfehérvár, 8000, Hungary

Location

Vital Medical Center

Veszprém, 8200, Hungary

Location

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Zalaegerszeg AS

Zalaegerszeg, 8900, Hungary

Location

KLIMED Marek Klimkiewicz

Bialystok, 15-765, Poland

Location

ClinicMed Badurski i wspolnicy Spolka Jawna

Bialystok, 15-879, Poland

Location

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, 85-168, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Malopolskie Centrum Medyczne s.c.

Krakow, 30-510, Poland

Location

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, 90-242, Poland

Location

RCMed

Nowy Duninów, 09-505, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

Torun, 87-100, Poland

Location

Medycyna Kliniczna

Warsaw, 00-660, Poland

Location

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, 02-118, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.

Wroclaw, 53-224, Poland

Location

KLIMED Marek Klimkiewicz

Łomża, 18-404, Poland

Location

Glasgow Royal Infirmary

Glasgow, Strathclyde, G4 0SF, United Kingdom

Location

Whipps Cross University Hospital

London, E11 1NR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33263165 DERIVED

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Eugenia Kunina, senior clinical development manager
• Organization: Fresenius Kabi Swiss BioSim GmbH

clinical.development@fresenius-kabi.com

+41791093376

Study Officials

• Medical Responsible

  Fresenius Kabi SwissBioSim GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 14, 2017
• Study Start: January 31, 2017
• Primary Completion: May 28, 2018
• Study Completion: August 27, 2018
• Last Updated: December 20, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-12

Locations

PL (13); DE (2); BU (12); HU (7); CZ (10); GB (2)