Clinical trial • Phase III • Immunology | Musculoskeletal

Etanercept for Juvenile idiopathic arthritis

Phase III trial of Etanercept for Juvenile idiopathic arthritis.

Overview

Trial Therapeutic Area
Immunology | Musculoskeletal
Trial Disease
Juvenile idiopathic arthritis
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme | Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
10-07-2024
First CTIS Authorization Date
04-09-2024

Trial design

Randomised, reumaflex (methotrexate) 50 mg/ml solution for injection, pre-filled syringe; route: subcutaneous. dosing schedule not specified in the available data.-controlled Phase III trial across 20 sites in Italy.

Randomised
Yes
Comparator
Reumaflex (methotrexate) 50 mg/ml solution for injection, pre-filled syringe; route: subcutaneous. Dosing schedule not specified in the available data.
Target Sample Size
260
Trial Duration For Participant
365

Eligibility

Recruits 260 paediatric patients.

Pregnancy Exclusion
Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use highly effective contraceptive measures, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use highly effective contraceptive measures if sexually active
Vulnerable Population
Children aged 2 to 16 years are included; consent/assent requirements specified: competence to give written informed consent to be applied to parents and/or patients as appropriate; 'Duly executed, written, informed consent/assent obtained from the parents/patient' and separate ICFs for parent/patient are provided.

Inclusion criteria

  • {"criterion_text":"- Newly-diagnosed and synthetic or biologic DMARD-naïve children (only treatment with 1 NSAID is allowed and no corticosteroid joint injections prior to randomization) with a JIA classified according to the following ILAR categories: i. Oligoarthritis, ii. Rheumatoid factor negative polyarthritis"}
  • {"criterion_text":"- Active arthritis"}
  • {"criterion_text":"- Onset of JIA symptoms no more than 6 months before randomization, IV. Age 2 to 16 years at enrolment"}
  • {"criterion_text":"- Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use highly effective contraceptive measures, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use highly effective contraceptive measures if sexually active"}
  • {"criterion_text":"- Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate"}
  • {"criterion_text":"- Duly executed, written, informed consent/assent obtained from the parents/patient"}
  • {"criterion_text":"- Age 2 to 16 years at enrolment"}

Exclusion criteria

  • {"criterion_text":"- Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis"}
  • {"criterion_text":"- Patients who need systemic treatment for uveitis"}
  • {"criterion_text":"- Tuberculosis related issues: patients are excluded from the study if they have: a. Active TB or a history of incompletely treated TB; b. PPD or QuantiFERON-TB positive patients (with no active disease) unless it is documented by a specialist that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the study investigator and / or an infectious disease specialist; c. Suspected extrapulmonary TB infection; d. Patients at high risk of contracting TB, such as close contact with individual with active or latent TB."}
  • {"criterion_text":"- Previous treatment with any synthetic or biologic DMARD"}
  • {"criterion_text":"- Any live attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines and throughout the study. Killed or inactive vaccine may be permitted based on the investigator’s judgment"}
  • {"criterion_text":"- Prior or current history of malignancy or any other significant concomitant illness(es) as per the treating physician evaluation"}
  • {"criterion_text":"- Any of the following laboratory abnormalities based on the most recent laboratory results: a. White blood cell (WBC) count <3.50 x 103/mm3 (SI units: <3.50 x 109/L) and neutrophils < 1x109/L; b. Hemoglobin < 8.5 g/dL (SI units: <85 g/L); c. Platelet Count < 125,0000/mm3 or ≥1,000,000/mm3 (SI units: <125 x 109/L or ≥1,000 x 109/L; d. Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) ≥ 2.0 x upper limit of normal (ULN)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical remission on or off medication at 12 months.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- The rate of patients who achieve the JADAS/JIA ACR state of ID at any single point in time throughout the study period will be compared between the 2 arms.","definition_or_measurement_approach":"Comparison between the two arms using achievement of JADAS/JIA ACR state of inactive disease (ID) at any single time point during the study period."}

Recruitment

Planned Sample Size
260
Recruitment Window Months
84
Consent Approach
Informed consent and assent obtained from parents and/or patients as appropriate. Separate subject information and informed consent forms available for parent, pre-pubertal patient and post-pubertal patient (documents listed). Specific languages not stated.

Geography

Total Number Of Sites
20
Total Number Of Participants
260

Italy

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
13-12-2024
Processing Time Days
144
Number Of Sites
20
Number Of Participants
260

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Unità trial clinici di reumatologia
Principal Investigator Name
Alessandro De Fanti
Principal Investigator Email
alessandro.defanti@asmn.re.it
Contact Person Name
Alessandro De Fanti
Contact Person Email
alessandro.defanti@asmn.re.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Clinica Pediatrica
Principal Investigator Name
Patrizia Barone
Principal Investigator Email
barone@policlinico.unict.it
Contact Person Name
Patrizia Barone
Contact Person Email
barone@policlinico.unict.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
UOC Reumatologia e Malattie Autoinfiammatorie
Principal Investigator Name
Alessandro Consolaro
Principal Investigator Email
alessandroconsolaro@gaslini.org
Contact Person Name
Alessandro Consolaro
Site Name
Ospedale Vito Fazzi Lecce
Department Name
UOSD Reumatologia e Immunologia Pediatrica
Principal Investigator Name
Adele Civino
Contact Person Name
Adele Civino
Site Name
Ospedale Pediatrico Giovanni XXIII, AOU Consorziale Policlinico di Bari
Department Name
UOC Pediatria
Principal Investigator Name
Francesco La Torre
Principal Investigator Email
reumapedlatorre@gmail.com
Contact Person Name
Francesco La Torre
Contact Person Email
reumapedlatorre@gmail.com
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
Divisione di Reumatologia
Principal Investigator Name
Maurizio Gattinara
Principal Investigator Email
mauriziovirgilio.gattinara@gpini.it
Contact Person Name
Maurizio Gattinara
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
Dipartimento di Pediatria
Principal Investigator Name
Luciana Breda
Principal Investigator Email
info@pec.as12abruzzo.it
Contact Person Name
Luciana Breda
Contact Person Email
info@pec.as12abruzzo.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Dipartimento Universitario
Principal Investigator Name
Maria Cristina Maggio
Principal Investigator Email
mariacristina.maggio3@gmail.com
Contact Person Name
Maria Cristina Maggio
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Salute della Donna, del Bambino e dell'Adolescente
Principal Investigator Name
Angela Miniaci
Principal Investigator Email
angela.miniaci@aosp.bo.it
Contact Person Name
Angela Miniaci
Contact Person Email
angela.miniaci@aosp.bo.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
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
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Unita' di Immunologia e Reumatologia Pediatrica
Principal Investigator Name
Marco Cattalini
Principal Investigator Email
marco.cattalini@gmail.com
Contact Person Name
Marco Cattalini
Contact Person Email
marco.cattalini@gmail.com
Site Name
Ospedale Santa Chiara
Department Name
Pediatria
Principal Investigator Name
Sofia D'Elios
Principal Investigator Email
sofia.delios@gmail.com
Contact Person Name
Sofia D'Elios
Contact Person Email
sofia.delios@gmail.com
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Dipartimento di Pediatria F.Fede
Principal Investigator Name
Alma Nunzia Olivieri
Principal Investigator Email
almanunzia.olivieri@unicampania.it
Contact Person Name
Alma Nunzia Olivieri
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Dipartimento di Pediatria
Principal Investigator Name
Gabriele Simonini
Principal Investigator Email
gabriele.simonini@unifi.it
Contact Person Name
Gabriele Simonini
Contact Person Email
gabriele.simonini@unifi.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento di Pediatria
Principal Investigator Name
Maria Alessio
Principal Investigator Email
mariolina.alessio@gmail.com
Contact Person Name
Maria Alessio
Contact Person Email
mariolina.alessio@gmail.com
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dip.to di Scienze Pediatriche e dell'Adolescenza
Principal Investigator Name
Davide Montin
Principal Investigator Email
davide.montin@gmail.com
Contact Person Name
Davide Montin
Contact Person Email
davide.montin@gmail.com
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Dipartimento Salute Donna, Infanzia ed età evolutiva
Principal Investigator Name
Federico Marchetti
Principal Investigator Email
federico.marchetti@auslromagna.it
Contact Person Name
Federico Marchetti
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
UOC Pediatria Specialistica e Malattie Rare
Principal Investigator Name
Romina Gallizzi
Principal Investigator Email
rgallizzi@unicz.it
Contact Person Name
Romina Gallizzi
Contact Person Email
rgallizzi@unicz.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Scienze della Riproduzione e dello Sviluppo
Principal Investigator Name
Serena Pastore
Principal Investigator Email
serena.pastore82@gmail.com
Contact Person Name
Serena Pastore
Contact Person Email
serena.pastore82@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UOC Pediatria a Media Intensità di Cure
Principal Investigator Name
Giovanni Filocamo
Principal Investigator Email
giovanni.filocamo@gmail.com
Contact Person Name
Giovanni Filocamo
Contact Person Email
giovanni.filocamo@gmail.com

Sponsor

Primary sponsor

Full Name
Giannina Gaslini Institute For Scientific Hospitalization And Care
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Third parties

  • {"country":"","full_name":"Pfizer","duties_or_roles":"IMP donated (Enbrel) as stated in source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Enbrel 10 mg powder and solvent for solution for injection for paediatric use
Active Substance
Etanercept
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised
Maximum Dose
1200 mg
Investigational Product Name
Enbrel 25 mg solution for injection in pre-filled syringe
Active Substance
Etanercept
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised
Maximum Dose
1200 mg
Investigational Product Name
Enbrel 50 mg solution for injection in pre-filled syringe
Active Substance
Etanercept
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised
Maximum Dose
1200 mg
Investigational Product Name
Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita
Active Substance
Methotrexate
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised
Maximum Dose
480 mg
Combination Treatment
Yes

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