Clinical trial • Phase IV • Immunology | Rare Disease
SARILUMAB for Systemic juvenile idiopathic arthritis | Juvenile idiopathic arthritis
Phase IV trial of SARILUMAB for Systemic juvenile idiopathic arthritis | Juvenile idiopathic arthritis.
Overview
- Trial Therapeutic Area
- Immunology | Rare Disease
- Trial Disease
- Systemic juvenile idiopathic arthritis | Juvenile idiopathic arthritis
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 17-07-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase IV trial across 27 sites in Italy, Germany, Ireland and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, sequential ascending repeated dose‑finding with dose‑escalation cohorts (sequential, ascending, repeated dose‑finding design).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 45
- Trial Duration For Participant
- 1092
Eligibility
Recruits 45 paediatric patients.
- Pregnancy Exclusion
- Pregnant or breast-feeding female adolescent patients.
- Vulnerable Population
- The trial includes vulnerable populations (children and adolescents aged 1–17 years). Consent is managed using age-appropriate subject information and informed consent/assent documents (parent/guardian consent and child/adolescent assent forms). Country-specific ICF and assent forms are available (multiple languages and versions for different age groups, and forms for participants turning 16/18 and for parental/legal representative consent).
Inclusion criteria
- {"criterion_text":"- Male and female patients aged ≥1 and ≤17 years (or country specified age requirement, ≥6 to ≤17 years for Russia) at the time of the screening visit."}
- {"criterion_text":"- Diagnosis of systemic JIA subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria OR According to 2024 EULAR/PReS recommendation at Screening."}
- {"criterion_text":"- Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying anti rheumatic drug (DMARD) as per investigator’s judgment."}
Exclusion criteria
- {"criterion_text":"- Body weight <10 kg or >60 kg for patients enrolled in the ascending dose cohorts, then body weight <10 kg for patients subsequently enrolled at the selected dose."}
- {"criterion_text":"- Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements)."}
- {"criterion_text":"- Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer."}
- {"criterion_text":"- Exclusion related to tuberculosis."}
- {"criterion_text":"- Exclusion criteria related to past or current infection other than tuberculosis."}
- {"criterion_text":"- Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator’s judgment."}
- {"criterion_text":"- Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product."}
- {"criterion_text":"- Laboratory abnormalities at the screening visit (identified by the central laboratory)."}
- {"criterion_text":"- Severe cardiac disease due to sJIA."}
- {"criterion_text":"- Pregnant or breast-feeding female adolescent patients."}
- {"criterion_text":"- Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening."}
- {"criterion_text":"- History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis."}
- {"criterion_text":"- If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label."}
- {"criterion_text":"- If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling."}
- {"criterion_text":"- If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline."}
- {"criterion_text":"- Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline."}
- {"criterion_text":"- Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab."}
- {"criterion_text":"- Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Assessment of PK parameter: maximum serum concentration observed (Cmax); Up to Week 12","definition_or_measurement_approach":"Maximum serum concentration observed (Cmax) measured through pharmacokinetic sampling up to Week 12."}
- {"endpoint_text":"- Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t); Up to Week 12","definition_or_measurement_approach":"AUC0-t calculated using the trapezoidal method over a dose interval from serum concentration versus time measurements up to Week 12."}
- {"endpoint_text":"- Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough); Up to Week 12","definition_or_measurement_approach":"Ctrough is the pre-dose (trough) serum concentration measured prior to treatment administration during repeated dosing, assessed up to Week 12."}
Secondary endpoints
- {"endpoint_text":"- Number of Adverse events; Core treatment phase: Up to Week 12, Extension phase:Up to Week 162","definition_or_measurement_approach":"Count and reporting of adverse events during core treatment (up to Week 12) and extension phase (up to Week 162)."}
- {"endpoint_text":"- Acceptability assessments (local tolerability); Core treatment phase: Up to Week 12, Extension phase:Up to Week 156","definition_or_measurement_approach":"Assessment of local tolerability and acceptability (e.g., local injection site reactions) during core and extension phases up to specified weeks."}
- {"endpoint_text":"- Proportion of participants with Investigator Global Assessment (IGA) of disease activity below a defined value on 1-100 VAS scale. Core treatment phase: Up to Week 12 Extension phase:At weeks 24, 48, and every 24 weeks up to Week 156.","definition_or_measurement_approach":"Proportion of participants with IGA score below prespecified threshold on 1–100 VAS at specified timepoints."}
- {"endpoint_text":"- Proportion of participants with Parent / patient Global Assessment (PGA) of well-being below a defined value on 1-100 VAS scale. Core treatment phase: Up to Week 12 Extension phase:At weeks 24, 48, and every 24 weeks up to Week 156.","definition_or_measurement_approach":"Proportion of participants with parent/patient global assessment (PGA) of well-being below prespecified threshold on 1–100 VAS at specified timepoints."}
- {"endpoint_text":"- Assessment of participants with clinically inactive disease (CID). Core treatment phase: Up to Week 12 Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156.","definition_or_measurement_approach":"Assessment of proportion/status of participants meeting criteria for clinically inactive disease at scheduled timepoints."}
- {"endpoint_text":"- Changes in glucocorticoid use. Core treatment phase: Up to Week 12 Extension phase:At weeks 24, 48, and every 24 weeks up to Week 156.","definition_or_measurement_approach":"Change from baseline in glucocorticoid dose/use measured at scheduled visits."}
- {"endpoint_text":"- Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate. Population according to the 2001 ILAR classification. Core treatment phase: Up to Week 12 Extension phase:At weeks 24, 48, and every 24 weeks up to Week 156.","definition_or_measurement_approach":"ACR response rates (ACR30/50/70/90/100) assessed per JIA ACR criteria (absence of fever) at specified visits."}
- {"endpoint_text":"- Change from baseline in individual JIA ACR components. Population according to the 2001 ILAR classification. Core treatment phase: Up to Week 12 Extension phase:At weeks 24, 48, and every 24 weeks up to Week 156.","definition_or_measurement_approach":"Changes from baseline for each component of the JIA ACR measures at scheduled timepoints."}
- {"endpoint_text":"- Change from baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS). Population according to the 2001 ILAR classification. Core treatment phase: Up to Week 12 Extension phase: Up to Week 156.","definition_or_measurement_approach":"Change from baseline in JADAS-27 score measured at scheduled visits up to Week 156."}
- {"endpoint_text":"- Assessment of participants with disease-related symptoms. Population according to the 2024 EULAR / PReS. At Week 4.","definition_or_measurement_approach":"Assessment of disease-related symptoms according to 2024 EULAR/PReS criteria at Week 4."}
- {"endpoint_text":"- Changes in IL-6 associated biomarkers. Population according to the 2001 ILAR classification and the 2024 EULAR / PReS. Up to week 12.","definition_or_measurement_approach":"Measurement of IL-6–associated biomarkers and change from baseline up to Week 12."}
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 125
- Consent Approach
- Informed consent is obtained from parent(s)/legal guardian(s) for minor participants, with age‑appropriate assent forms for children and adolescents. Separate ICF/assent templates are provided for different age groups (e.g., 6–10, 11–15, 16–17, adolescent-turned-adult and adult forms), parent/guardian information forms, partner/pregnancy information and pharmacogenetic consent forms. Documents exist in multiple languages corresponding to trial countries.
Methods
- Patient-facing recruitment materials and arrangements available (documented as K1/K2 recruitment arrangements and K2 recruitment materials).
- Use of illustrated/comic-book materials targeted to children (e.g., 'K2-recruitment-material-comic-book-understanding-your-study' and country-specific comic materials) aimed at explaining the study to pediatric participants.
- Welcome guides, parent brochures and patient 'passport' materials for families (documents titled welcome-guide, parentsbrochure, skypstudypassport, country-specific versions).
- Country-specific recruitment arrangements and materials available (multiple language versions: EN, ES, FR, DE, IT, BG, FI, HU, PT, RO, EL, etc.) associated with the member state submissions.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 37
Italy
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 06-08-2024
- Processing Time Days
- 42
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Pediatric Rheumatology International Trials Organisation
- Department Name
- Reumatologia
- Principal Investigator Name
- Alessandro Consolaro
- Principal Investigator Email
- alessandroconsolaro@gaslini.org
- Contact Person Name
- Alessandro Consolaro
- Contact Person Email
- alessandroconsolaro@gaslini.org
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Pediatria Immunoreumatologia
- Principal Investigator Name
- Giovanni Filocamo
- Principal Investigator Email
- giovanni.filocamo@policlinico.mi.it
- Contact Person Name
- Giovanni Filocamo
- Contact Person Email
- giovanni.filocamo@policlinico.mi.it
- Site Name
- Bambino Gesu Childrens Hospital
- Department Name
- U.O.C. Reumatologia
- Principal Investigator Name
- Fabrizio De Benedetti
- Principal Investigator Email
- fabrizio.debenedetti@opbg.net
- Contact Person Name
- Fabrizio De Benedetti
- Contact Person Email
- fabrizio.debenedetti@opbg.net
Germany
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Gesundheit Nord gGmbH Klinikverbund Bremen
- Department Name
- Eltern-Kind-Zentrum Prof. Hess
- Principal Investigator Name
- Frank Weller-Heinemann
- Principal Investigator Email
- Frank.Weller@gesundheitnord.de
- Contact Person Name
- Frank Weller-Heinemann
- Contact Person Email
- Frank.Weller@gesundheitnord.de
- Site Name
- HELIOS Klinikum Berlin-Buch GmbH
- Department Name
- Kinder- und Jugendmedizin
- Principal Investigator Name
- Ralf Trauzeddel
- Principal Investigator Email
- ralf.trauzeddel@helios-kliniken.de
- Contact Person Name
- Ralf Trauzeddel
- Contact Person Email
- ralf.trauzeddel@helios-kliniken.de
- Site Name
- Asklepios Klinik Sankt Augustin GmbH
- Department Name
- Allgmeine Kinderheilkunde
- Principal Investigator Name
- Gerd Horneff
- Principal Investigator Email
- g.horneff@asklepios.com
- Contact Person Name
- Gerd Horneff
- Contact Person Email
- g.horneff@asklepios.com
- Site Name
- Zentrum Fuer Kinder Und Jugendrheumatologie
- Department Name
- Pediatric Clinic / Kompetenzzentrum fur Sklerodermie im Kindes- und Jugendalter
- Principal Investigator Name
- Ivan Foeldvari
- Principal Investigator Email
- foeldvari@t-online.de
- Contact Person Name
- Ivan Foeldvari
- Contact Person Email
- foeldvari@t-online.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Paediatrie
- Principal Investigator Name
- Kirsten Minden
- Principal Investigator Email
- kirsten.minden@charite.de
- Contact Person Name
- Kirsten Minden
- Contact Person Email
- kirsten.minden@charite.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 17-07-2024
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Our Lady's Childrens Hospital
- Department Name
- Research and Innovation
- Principal Investigator Name
- Orla Killeen
- Principal Investigator Email
- orla.killeen@olchc.ie
- Contact Person Name
- Orla Killeen
- Contact Person Email
- orla.killeen@olchc.ie
Spain
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 23
- Number Of Sites
- 7
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Servicio de Reumatología Pediátrica
- Principal Investigator Name
- Esmeralda Nunez Cuadros
- Principal Investigator Email
- esmeralda.nunez.sspa@juntadeandalucia.es
- Contact Person Name
- Esmeralda Nunez Cuadros
- Contact Person Email
- esmeralda.nunez.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Unidad de Reumatología Pediátrica
- Principal Investigator Name
- Lucia Lacruz Perez
- Principal Investigator Email
- lacruz_lucper@gva.es
- Contact Person Name
- Lucia Lacruz Perez
- Contact Person Email
- lacruz_lucper@gva.es
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Unidad de Reumatología Pediátrica
- Principal Investigator Name
- Jordi Ánton López
- Principal Investigator Email
- jordi.anton@sjd.es
- Contact Person Name
- Jordi Ánton López
- Contact Person Email
- jordi.anton@sjd.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Unidad de Reumatología Pediátrica
- Principal Investigator Name
- Agustín Remesal Camba
- Principal Investigator Email
- agusremesal@hotmail.com
- Contact Person Name
- Agustín Remesal Camba
- Contact Person Email
- agusremesal@hotmail.com
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Unidad de Reumatología Pediátrica
- Principal Investigator Name
- Daniel Clemente Garulo
- Principal Investigator Email
- daniel.clemente@salud.madrid.org
- Contact Person Name
- Daniel Clemente Garulo
- Contact Person Email
- daniel.clemente@salud.madrid.org
- Site Name
- Hospital La Milagrosa S.A.
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Boris Anthony Blanco Caceres
- Principal Investigator Email
- blancobc@ext.vithas.es
- Contact Person Name
- Boris Anthony Blanco Caceres
- Contact Person Email
- blancobc@ext.vithas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Reumatología Pediátrica
- Principal Investigator Name
- Estefania Moreno Rizafa
- Principal Investigator Email
- estefania.moreno@vallhebron.cat
- Contact Person Name
- Estefania Moreno Rizafa
- Contact Person Email
- estefania.moreno@vallhebron.cat
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Pediatric Clinic
- Principal Investigator Name
- Lyubov Chochkova-Bukova
- Principal Investigator Email
- lbukova@yahoo.com
- Contact Person Name
- Lyubov Chochkova-Bukova
- Contact Person Email
- lbukova@yahoo.com
France
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 23
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Nephrologie, Rhumatologie et dermatologie Pediatriques
- Principal Investigator Name
- Alexandre Belot
- Principal Investigator Email
- alexandre.belot@chu-lyon.fr
- Contact Person Name
- Alexandre Belot
- Contact Person Email
- alexandre.belot@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Unite d'Immuno-hematologie et Rhumatologie pediatrique
- Principal Investigator Name
- Pierre Quartier-dit-Maire
- Principal Investigator Email
- pierre.quartier@aphp.fr
- Contact Person Name
- Pierre Quartier-dit-Maire
- Contact Person Email
- pierre.quartier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service de Medecine pediatrique, des Maladies Infectieuses et d'Immunologie Clinique
- Principal Investigator Name
- Eric Jeziorski
- Principal Investigator Email
- e-jeziorski@chu-montpellier.fr
- Contact Person Name
- Eric Jeziorski
- Contact Person Email
- e-jeziorski@chu-montpellier.fr
Finland
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Meilahti Hospital
- Department Name
- Hematology
- Principal Investigator Name
- Kristiina Aalto
- Principal Investigator Email
- kristiina.aalto@hus.fi
- Contact Person Name
- Kristiina Aalto
- Contact Person Email
- kristiina.aalto@hus.fi
Hungary
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 17
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Semmelweis University
- Department Name
- Reumatológia-Immunológia Osztály
- Principal Investigator Name
- Tamas Constantin
- Principal Investigator Email
- constantin.tamas@semmelweis.hu
- Contact Person Name
- Tamas Constantin
- Contact Person Email
- constantin.tamas@semmelweis.hu
Greece
- Earliest CTIS Part Ii Submission Date
- 14-11-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 56
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Nosokomeio Paidon I Agia Sofia
- Department Name
- A' pediatric Clinic of University of Athens
- Principal Investigator Name
- Eleni Tsitsami
- Principal Investigator Email
- e.tsitsami@paidon-agiasofia.gr
- Contact Person Name
- Eleni Tsitsami
- Contact Person Email
- e.tsitsami@paidon-agiasofia.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- A’ pediatric Clinic of Aristotle University of Thessaloniki
- Principal Investigator Name
- Vasiliki Sgouropoulou
- Principal Investigator Email
- vsgouro@auth.gr
- Contact Person Name
- Vasiliki Sgouropoulou
- Contact Person Email
- vsgouro@auth.gr
Romania
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
- Department Name
- First Pediatric clinic
- Principal Investigator Name
- Mirela Crisan
- Principal Investigator Email
- Mirelacrisan_cluj@yahoo.co.uk
- Contact Person Name
- Mirela Crisan
- Contact Person Email
- Mirelacrisan_cluj@yahoo.co.uk
Portugal
- Earliest CTIS Part Ii Submission Date
- 07-01-2026
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Pediatric Rheumatology Unit
- Principal Investigator Name
- Marta Conde
- Principal Investigator Email
- marta.conde@ulssjose.min-saude.pt
- Contact Person Name
- Marta Conde
- Contact Person Email
- marta.conde@ulssjose.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Rheumatology and Pediatrics Department
- Principal Investigator Name
- Filipa Ramos
- Principal Investigator Email
- filipa.ramos@ulssm.min-saude.pt
- Contact Person Name
- Filipa Ramos
- Contact Person Email
- filipa.ramos@ulssm.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Ospedale Pediatrico Bambino Gesu","duties_or_roles":"code 13","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"code 15; Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Regeneron Pharmaceuticals Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- sarilumab
- Active Substance
- SARILUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (prodAuthStatus:1)
- Maximum Dose
- 300 mg (maxDailyDoseAmount: 300 mg indicated in product data)
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