Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004369-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis.
Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSB11456 | Experimental |
| |
| RoActemra® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSB11456 | Drug | Participants will receive MSB11456 subcutaneously, once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: Tender Joint Count (TJC), Swollen Joint Count (SJC), erythrocyte sedimentation rate (ESR) and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*GH + 0.70*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as:
A negative change from baseline indicates an improvement. | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: TJC, SJC, ESR and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*GH + 0.70*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as:
A negative change from baseline indicates an improvement. For weeks 30, 42 and 52, the extended baseline (week 24) was used for the change in DAS28-ESR calculation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
American College of Rheumatology functional class IV as defined by the ACR classification of functional status or wheelchair/bedbound.
Previously received tocilizumab, an investigational or licensed biosimilar of tocilizumab or any interleukin-6 acting drugs.
Prior use of targeted synthetic disease-modifying anti-rheumatic drugs like janus kinase inhibitors.
Prior use of more than 2 biologic treatments for rheumatoid arthritis.
Received a live or attenuated vaccine within 4 weeks prior to randomization.
Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. Investigator should specifically evaluate the participant's eligibility taking into consideration COVID-19 risk factors and situation.
Has a serious and/or unstable and/or poorly controlled medical condition such as but not limited to poorly controlled diabetes, unstable ischemic heart disease, uncontrolled hypertension or other cardiovascular, cerebrovascular, cardiovascular, gastrointestinal disease, hepatic, renal, hematological, endocrine, nervous system or pulmonary disease or other relevant medical condition or a history of clinically significant disease or any other condition that, in the opinion of the Investigator, would put the participant at risk by participation in the study.
Confirmed or, based on the signs and symptoms observed at the time of assessment, suspected active COVID-19 infection at the time of screening and/or randomization.
Has had any infection as follows:
Medical evidence of active or latent tuberculosis as indicated by a positive QuantiFERON®-TB Gold Plus test, chest X-ray and/or clinical examination or has had active or latent tuberculosis disease at any time in the past.
Received a COVID 19 vaccine within 4 weeks prior to randomization, are receiving ongoing COVID-19 vaccination at the time of screening or plan to receive COVID-19 vaccination before the completion of the Week 30 visit of the study. COVID-19 vaccination is considered ongoing if a multidose regimen has been started but has not been completed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Hipokrat 2000 OOD | Haskovo | Haskovo | 6300 | Bulgaria | ||
| MHAT "Lyulin" EAD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38316489 | Derived | Zubrzycka-Sienkiewicz A, Klama K, Ullmann M, Petit-Frere C, Baker P, Monnet J, Illes A. Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study. RMD Open. 2024 Feb 5;10(1):e003596. doi: 10.1136/rmdopen-2023-003596. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Core Treatment Period: MSB11456 | Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). |
| FG001 | Core Treatment Period: RoActemra® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Week 0 to Week 24 |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2021 | Sep 20, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EU-approved RoActemra |
| Drug |
Participants will receive EU-approved RoActemra® subcutaneously, once a week. |
|
| Baseline, Week 2, Week 4, Week 8, Week 12, Week 16; Extended Period Baseline (Week 24), Week 30, Week 42, and Week 52 |
| Number of Participants With 20% Improvement in American College of Rheumatology (ACR20) Response | ACR20 was defined as the number of participants with at least 20% improvement from baseline in number of tender and swollen joints (68/66 joint count), and at least 20% improvement from baseline in three or more of the 5 ACR Core Set measures:
| Baseline; Week 24 |
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE) | Baseline to end of study, up to Week 63 |
| Number of Participants Who Experienced One or More Treatment-Emergent Serious Adverse Event (TESAE) | Baseline to end of study, up to Week 63 |
| Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) | Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55 |
| Anti-Drug Antibodies (ADAs) Titer Levels | Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55 |
| Percentage of Participants With Neutralizing Antibodies (NAb) | Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55 |
| Sofia |
| Sofia |
| 1336 |
| Bulgaria |
| Military Medical Academy - Sofia | Sofia | Sofia | 1606 | Bulgaria |
| Medical Center N.I.Pirogov EOOD | Sofia | Sofia | 1612 | Bulgaria |
| Medical Center MedConsult Pleven | Pleven | 5800 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Pulmed | Plovdiv | 4002 | Bulgaria |
| Multiprofile Hospital for Active Treatment Plovdiv | Plovdiv | 4003 | Bulgaria |
| Medical Center Teodora | Rousse | 7012 | Bulgaria |
| Diagnostic and Consultative Center Equita | Varna | 9002 | Bulgaria |
| MC Sanador M | Vidin | 3703 | Bulgaria |
| Revmatologie, s.r.o. | Brno | Jihormoravsky KRAJ | 638 00 | Czechia |
| Medical Plus | Uherské Hradiště | Jihormoravsky KRAJ | 686 01 | Czechia |
| Revmatologie MUDr. Zuzana Urbanova | Prague | Prague | 140 00 | Czechia |
| CCR Ostrava | Ostrava | Severomoravsky KRAJ | 702 00 | Czechia |
| Revmatologie MUDr. Klára Šírová s.r.o. | Ostrava | Severomoravsky KRAJ | 702 00 | Czechia |
| PV-Medical Services, s.r.o. | Zlín | Severomoravsky KRAJ | 760 01 | Czechia |
| Vesalion s.r.o. | Ostrava | 702 00 | Czechia |
| Revmatologicky Ustav | Prague | 128 50 | Czechia |
| Helsicore - Israeli Georgian Medical Research Clinic | Tbilisi | 0112 | Georgia |
| Research Institute of Clinical Medicine | Tbilisi | 0112 | Georgia |
| The First University Clinic | Tbilisi | 0141 | Georgia |
| EVEX Hospitals - Caraps Medline | Tbilisi | 0159 | Georgia |
| Tbilisi Heart and Vascular Clinic | Tbilisi | 0159 | Georgia |
| MediClub Georgia | Tbilisi | 0160 | Georgia |
| Georgian Dutch Hospital Ltd | Tbilisi | 0172 | Georgia |
| Mtskheta Street Clinic | Tbilisi | 0179 | Georgia |
| Tbilisi Heart Center | Tbilisi | 0186 | Georgia |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | Csongrád megye | 6725 | Hungary |
| Csongrad Megyei Dr. Bugyi Istvan Korhaz | Szentes | Csongrád megye | 6600 | Hungary |
| DRC Gyogyszervizsgalo Kozpont Kft. | Székesfehérvár | Fejér | 8000 | Hungary |
| SALDINVEST Befektetesi es Vagyonkezelo Korlatolt Felelossegu Tarsasag | Székesfehérvár | Fejér | 8000 | Hungary |
| Integrity Gyogyaszati Kozpont | Zalaegerszeg | Zala County | 8900 | Hungary |
| Revita Reumatologiai Rendelo | Budapest | 1027 | Hungary |
| MÁV Kórház és Rendelőintézet Rheumatológia | Szolnok | 5000 | Hungary |
| Vital Medical Center Orvosi es Fogaszati Kozpont | Veszprém | 8200 | Hungary |
| Institutia Medico-Sanitara Publica Institutul de Cardiologie | Chisinau | 2025 | Moldova |
| Spitalul Clinic Republican | Chisinau | 2025 | Moldova |
| IMSP Spitalul Clinic Municipal Sfanta Treime | Chisinau | 2068 | Moldova |
| Instituţia Medico-Sanitară Publică Institutul de Cardiologie | Chisinau | MD 2025 | Moldova |
| Solumed Centrum Medyczne | Poznan | Greater Poland Voivodeship | 60-529 | Poland |
| Centrum Badan Klinicznych S.C. | Poznan | Greater Poland Voivodeship | 60-773 | Poland |
| Ai Centrum Medyczne | Poznan | Greater Poland Voivodeship | 61-113 | Poland |
| Centrum Medyczne HCP | Poznan | Greater Poland Voivodeship | 61-485 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-068 | Poland |
| Nasz Lekarz Przychodnie Medyczne | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Grazyna Pulka Specjalistyczny Osrodek All-med | Krakow | Lesser Poland Voivodeship | 30-033 | Poland |
| Pratia MCM Krakow | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| WroMedica | Wroclaw | Lower Silesian Voivodeship | 51-685 | Poland |
| Centrum Medyczne Oporow | Wroclaw | Lower Silesian Voivodeship | 52-416 | Poland |
| Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszow Lubelski | Tomaszów Lubelski | Lublin Voivodeship | 22-600 | Poland |
| Twoja Przychodnia-Centrum Medyczne Nowa Sol | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| RCMed Oddzial Sochaczew | Sochaczew | Masovian Voivodeship | 96-500 | Poland |
| Medycyna Kliniczna | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| Rheuma Medicus Zaklad Opieki Zdrowotnej | Warsaw | Masovian Voivodeship | 02-118 | Poland |
| Ars Rheumatica - Reumatika Centrum Reumatologii | Warsaw | Masovian Voivodeship | 02-691 | Poland |
| Barwijuk Clinics | Warsaw | Masovian Voivodeship | 02-884 | Poland |
| Centrum Medyczne AMED Warszawa Targowek | Warsaw | Masovian Voivodeship | 03-291 | Poland |
| SANUS Szpital Specjalistyczny | Stalowa Wola | Podkarpackie Voivodeship | 37-450 | Poland |
| Osteo-Medic | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| ClinicMed Daniluk Nowak Spolka Jawna | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Centrum Medyczne Pratia w Gdyni | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| Silmedic w Swidniku | Katowice | Silesian Voivodeship | 40-282 | Poland |
| Ambulatorium Sp. z | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Centrum Terapii Wspolczesnej | Lodz | Łódź Voivodeship | 90-242 | Poland |
| TRIALMED CRS Piotrków Trybunalski | Piotrkow Trybunalski | Łódź Voivodeship | 97-300 | Poland |
| Clinical Rheumatological Hospital Number 25 | Saint Petersburg | Sankt-Peterburg | 190068 | Russia |
| Kazan State Medical University | Kazan' | Tatarstan Republic | 420103 | Russia |
| State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2 | Yaroslavl | Yaroslavlr | 150023 | Russia |
| Chelyabinsk Regional Clinical Hospital | Chelyabinsk | 454076 | Russia |
| Medical Center Revma-Med | Kemerovo | 650070 | Russia |
| NIARMEDIK - Clinic on Clinic on Kitai Gorod | Moscow | 101000 | Russia |
| Medical Center Health Family | Novosibirsk | 630099 | Russia |
| Polyclinic of Private Security Personnel | Saint Petersburg | 192007 | Russia |
| Saratov Regional Clinical Hospital | Saratov | 410053 | Russia |
| Departmental Hospital at Smolensk Station of JSC RZhD | Smolensk | 214025 | Russia |
| Biomed | Vladimir | 600005 | Russia |
| CjSC "Center of Family Medicine" | Yekaterinburg | 620043 | Russia |
| Institute of Rheumatology | Belgrade | 11000 | Serbia |
| Institut za Lecenje i Rehabilitaciju Niška Banja | Niška Banja | 18205 | Serbia |
| Specijalna Bolnica za Reumatske bolesti Novi Sad | Novi Sad | 21112 | Serbia |
| General Hospital Djordje Jovanovic Zrenjanin | Zrenjanin | 23000 | Serbia |
| REUMEX s.r.o. | Rimavská Sobota | 979 01 | Slovakia |
| LERAM s.r.o. | Topoľčany | 95501 | Slovakia |
| ALBAMED s.r.o. | Zvolen | 960 01 | Slovakia |
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
| FG002 | Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456 | Participants who received MSB11456 during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52). |
| FG003 | Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456 | Participants who received EU-approved RoActemra® during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52). |
| FG004 | Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra® | Participants who received EU-approved RoActemra® during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52). |
| Received Treatment |
|
| COMPLETED | Re-randomized at Week 24 |
|
| NOT COMPLETED |
|
|
| Week 24 to Week 63 |
|
|
The Intent-To-Treat (ITT) Analysis Set: includes all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Core Treatment Period: MSB11456 | Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). |
| BG001 | Core Treatment Period: RoActemra® | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: Tender Joint Count (TJC), Swollen Joint Count (SJC), erythrocyte sedimentation rate (ESR) and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*GH + 0.70*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as:
A negative change from baseline indicates an improvement. | ITT Analysis Set: includes all randomized participants. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline; Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: TJC, SJC, ESR and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*GH + 0.70*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as:
A negative change from baseline indicates an improvement. For weeks 30, 42 and 52, the extended baseline (week 24) was used for the change in DAS28-ESR calculation. | ITT Analysis Set: includes all randomized participants in either the Core Treatment period or the Extended Treatment period and who had a result at baseline and at each specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16; Extended Period Baseline (Week 24), Week 30, Week 42, and Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With 20% Improvement in American College of Rheumatology (ACR20) Response | ACR20 was defined as the number of participants with at least 20% improvement from baseline in number of tender and swollen joints (68/66 joint count), and at least 20% improvement from baseline in three or more of the 5 ACR Core Set measures:
| ITT Analysis Set: includes all randomized participants. | Posted | Count of Participants | Participants | Baseline; Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE) | Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). | Posted | Count of Participants | Participants | Baseline to end of study, up to Week 63 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced One or More Treatment-Emergent Serious Adverse Event (TESAE) | Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). | Posted | Count of Participants | Participants | Baseline to end of study, up to Week 63 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) | All participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra) in either the Core Treatment Period or the Extended Treatment Period and had a valid ADA result at the specific time points. | Posted | Number | percentage of participants | Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-Drug Antibodies (ADAs) Titer Levels | All participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra) in either the Core Treatment Period or the Extended Treatment Period and had a valid ADA result at the specific time points. | Posted | Geometric Mean | Full Range | titer | Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Neutralizing Antibodies (NAb) | All participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra) in either the Core Treatment Period or the Extended Treatment Period and had a valid ADA result at the specific time points. | Posted | Number | percentage of participants | Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55 |
|
Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MSB11456 | All participants who received MSB11456 in the Core Treatment Period (Baseline to Week 24) and who could then be re-randomized to continue MSB11456 in the Extended Treatment Period (Week 24 to Week 52). | 0 | 302 | 51 | 302 | 163 | 302 |
| EG001 | Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456 | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). | 1 | 139 | 20 | 139 | 82 | 139 |
| EG002 | EU-approved RoActemra® | All participants who received EU-approved RoActemra® in the Core Treatment Period (Baseline to Week 24) and who could then re-randomized to continue RoActemra® in the Extended Treatment Period (Week 24 to Week 52). | 3 | 163 | 33 | 163 | 92 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Follicular thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hilar lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Mycobacterium tuberculosis complex test positive | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development | Fresenius Kabi SwissBioSim GmbH | 793075735 | +41 | clinical.development@fresenius-kabi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2022 | Sep 20, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Death |
|
| Withdrawal by Subject |
|
| Miscellaneous |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Poland |
|
| Moldova |
|
| Georgia |
|
| Slovakia |
|
| Bulgaria |
|
| Serbia |
|
| Russia |
|
| OG001 |
| Core Treatment Period: RoActemra® |
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). |
| OG002 | Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456 | Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
| OG003 | Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456 | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
| OG004 | Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra® | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
|
|
| Participants |
|
|
|
|
|
|
|
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
| OG004 | Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra® | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
|
|
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
| OG004 | Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra® | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
|
|
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
| OG004 | Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra® | Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|