Clinical trial • Phase IV • Immunology

TOFACITINIB for Juvenile idiopathic arthritis

Phase IV trial of TOFACITINIB for Juvenile idiopathic arthritis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Juvenile idiopathic arthritis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody | Other antibody | Small molecule | Peptide/protein/enzyme
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
03-07-2024
First CTIS Authorization Date
29-10-2024

Trial design

Randomised, early biomarker-guided withdrawal versus standard/late withdrawal (maintenance of stable treatment intensity over 12 months). no specific drug, dose or schedule defined as comparator in the documentation; the comparison is strategy-based (early withdrawal guided by imaging and multi-omics vs continued standard treatment for 12 months).-controlled Phase IV trial in Belgium, Denmark, Italy and others.

Randomised
Yes
Comparator
Early biomarker-guided withdrawal versus standard/late withdrawal (maintenance of stable treatment intensity over 12 months). No specific drug, dose or schedule defined as comparator in the documentation; the comparison is strategy-based (early withdrawal guided by imaging and multi-Omics vs continued standard treatment for 12 months).
Biomarker Stratified
True - subclinical inflammation assessed by imaging and multi-Omics (patients without subclinical inflammation identified by imaging/multi-Omics are considered for biomarker-guided withdrawal)
Target Sample Size
328
Trial Duration For Participant
365

Eligibility

Recruits 328 paediatric patients.

Pregnancy Exclusion
Pregnant and breastfeeding individuals
Vulnerable Population
Children/minors are the trial population (paediatric trial). Consent is required from parents/legal guardians: 'Duly executed, written, informed consent obtained from the patient’s parents/legal guardian.' The protocol states competence to give written informed consent is applied to parents and/or patients as appropriate. Age-specific subject information and consent forms (parent/guardian forms and ICFs for ages 6-11 and 12-17) are included in the submitted documents (country/language-specific versions present).

Inclusion criteria

  • {"criterion_text":"- Children with JIA according to the ILAR classification (Oligoarthritis, Rheumatoid factor negative polyarthritis, Rheumatoid factor positive polyarthritis, Psoriatic arthritis, Enthesitis-related arthritis)\n- JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.\n- JIA patients who are receiving cs/b/bs/tsDMARDs according to the label indication.\n- 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\n- Duly executed, written, informed consent obtained from the patient’s parents/legal guardian.\n- Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must have no intention of conceiving while on treatment with antirheumatic drugs"}

Exclusion criteria

  • {"criterion_text":"- Patients with systemic JIA according to ILAR criteria\n- Patients with undifferentiated arthritis according to ILAR criteria\n- Patients with severe disease-related ocular damage and who need systemic treatment for uveitis\n- Patients who had received glucocorticoid treatment 3 months prior to baseline visit\n- Patients who had previously unsuccessfully attempted tapering cs/b/bs/tsDMARDs\n- Patients with severe damage as per caring physician measured\n- Prior or current history of other significant concomitant illness(es) that, according to the Investigator’s judgment, would adversely affect the patient’s participation in the study. These include, but are not limited to gastrointestinal, hepatobiliary, pulmonary, nonmalignant lymphoproliferative diseases, other lymphatic disease(s), psychiatric disorders, history of inflammatory bowel disease, or previous gastrointestinal perforation, etc.\n- Pregnant and breastfeeding individuals\n- Participation in other interventional clinical trials for the entire duration of the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Rate of flares: the rate of patients who experience disease flare at any time throughout the study period will be compared between the two arms.","definition_or_measurement_approach":"Compare the proportion (rate) of patients experiencing disease flare at any time during the study period between the two randomized arms."}

Secondary endpoints

  • {"endpoint_text":"- Time to Flare: time from randomization to flare","definition_or_measurement_approach":"Measured as time (days) from randomization to occurrence of disease flare."}

Recruitment

Planned Sample Size
328
Recruitment Window Months
25
Consent Approach
Written informed consent is required from parents/legal guardians for minors ('Duly executed, written, informed consent obtained from the patient’s parents/legal guardian.'). Competence to give written informed consent applies to parents and/or patients as appropriate. Age-specific information/consent forms are provided (parent/guardian forms and ICFs for 6-11 yr and 12-17 yr). Country/language-specific ICFs are included in the documents (examples: EN, IT, NL, PT, ES, CZ, LT versions listed).

Geography

Total Number Of Sites
24
Total Number Of Participants
328

Belgium

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
31-10-2024
Processing Time Days
16
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Antwerp University Hospital
Department Name
Pediatrics
Contact Person Name
Benson Ogunjimi
Contact Person Email
benson.ogunjimi@uza.be

Denmark

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
29-10-2024
Processing Time Days
89
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Aarhus Universitetshospital
Department Name
Pediatric rheumatology unit
Contact Person Name
Mia Glerup
Contact Person Email
miagleru@rm.dk

Italy

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
390
Number Of Sites
16
Number Of Participants
288

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Divisione di Pediatria
Contact Person Name
Bianca Lattanzi
Site Name
ASST Fatebenefratelli Sacco
Department Name
Pediatric Rheumatology Unit, Department of Childhood and Developmental Medicine
Contact Person Name
Angela Mauro
Contact Person Email
angela.mauro@asst-fbf-sacco.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Reumatologia e Malattie Autoinfiammatorie
Contact Person Name
Clara Malattia
Contact Person Email
claramalattia@gaslini.org
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
F.Fede Rheumatology Department
Contact Person Name
Maria Francesca Gicchino
Contact Person Email
francesca.gicchino@gmail.com
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Dipartimento di Pediatria
Contact Person Name
Gabriele Simonini
Contact Person Email
gabriele.simonini@unifi.it
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
Divisione di Reumatologia
Contact Person Name
Achille Marino
Contact Person Email
achillemarino6@gmail.com
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Scienze della Riproduzione e dello Sviluppo
Contact Person Name
Serena Pastore
Contact Person Email
serena.pastore82@gmail.com
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento di Pediatria
Contact Person Name
Roberta Naddei
Contact Person Email
roberta.naddei@unina.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
UOC Pediatria Specialistica e Malattie Rare
Contact Person Name
Romina Gallizzi
Contact Person Email
rgallizzi@unicz.it
Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Dipartimento di Pediatria
Contact Person Name
Luciana Breda
Contact Person Email
luciana.bredach@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Clinica Pediatrica
Contact Person Name
Patrizia Barone
Contact Person Email
barone@policlinico.unict.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Pediatric Rheumatology
Contact Person Name
Giovanni Filocamo
Contact Person Email
giovanni.filocamo@gmail.com
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Materno Infantile, UO Nefrologia e Reumatologia Pediatrica
Contact Person Name
Giovanni Conti
Contact Person Email
giovanni.conti@polime.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
UOSD Reumatologia e Immunologia Pediatrica
Contact Person Name
Adele Civino
Contact Person Email
adelecivino@gmail.com
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Divisione di Pediatria
Contact Person Name
Barbara Bigucci
Contact Person Email
barbara.bigucci@auslromagna.it
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
Contact Person Name
Angela Miniaci
Contact Person Email
angela.miniaci@aosp.bo.it

Czechia

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
25-07-2025
Processing Time Days
283
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Paediatric Department
Contact Person Name
Rudolf Horvath
Contact Person Email
rudolf.horvath@fnmotol.cz

Spain

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
385
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Department of Pediatric Rheumatology
Contact Person Name
Inmaculada Calvo Penades
Contact Person Email
calvo_inm@gva.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Rheumatology
Contact Person Name
Antonio Jose Mera Varela
Contact Person Email
antonio.mera.varela@sergas.es

Portugal

Earliest CTIS Part Ii Submission Date
17-09-2024
Latest Decision Or Authorization Date
08-08-2025
Processing Time Days
325
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Rheumatology
Contact Person Name
Sandra Sousa

Lithuania

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
325
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Centre of Pediatrics
Contact Person Name
Skirmante Rusoniene
Contact Person Email
skirmante.rusoniene@gmail.com
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Paediatric Department
Contact Person Name
Sarunas Rudaitis

Sponsor

Primary sponsor

Full Name
IRCCS Istituto Giannina Gaslini
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
XELJANZ 1 mg/mL oral solution
Active Substance
TOFACITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketingAuthNumber: EU/1/17/1178/015)
Maximum Dose
5 mg (maxDailyDoseAmount: 5)
Investigational Product Name
XELJANZ 5 mg film-coated tablets
Active Substance
TOFACITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketingAuthNumber: EU/1/17/1178/002)
Maximum Dose
5 mg (maxTotalDoseAmount: 5)
Investigational Product Name
Cosentyx 150 mg solution for injection in pre-filled syringe
Active Substance
SECUKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/14/980/002)
Maximum Dose
150 mg
Investigational Product Name
Cosentyx 75 mg solution for injection in pre-filled syringe
Active Substance
SECUKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/14/980/012)
Maximum Dose
75 mg
Investigational Product Name
Cosentyx 150 mg solution for injection in pre-filled pen
Active Substance
SECUKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (euMpNumber: PRD4384703)
Maximum Dose
150 mg
Investigational Product Name
Humira 40 mg solution for injection in pre-filled pen
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/03/256/007)
Maximum Dose
40 mg
Investigational Product Name
Humira 40 mg solution for injection in pre-filled syringe
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/03/256/002)
Maximum Dose
40 mg
Investigational Product Name
Humira 20 mg solution for injection in pre-filled syringe
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/03/256/022)
Maximum Dose
20 mg
Investigational Product Name
ORENCIA 250 mg powder for concentrate for solution for infusion
Active Substance
ABATACEPT
Modality
Other antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/07/389/003)
Maximum Dose
10 mg/kg (maxTotalDoseAmount: 10)
Investigational Product Name
ORENCIA 125 mg solution for injection in pre-filled syringe
Active Substance
ABATACEPT
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/07/389/006)
Maximum Dose
125 mg
Investigational Product Name
RoActemra 20 mg/mL concentrate for solution for infusion
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/08/492/003)
Maximum Dose
10 mg/kg
Investigational Product Name
RoActemra 162 mg solution for injection in pre-filled pen.
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (euMpNumber: PRD6143596)
Maximum Dose
162 mg
Investigational Product Name
Simponi 50 mg solution for injection in pre-filled syringe
Active Substance
GOLIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/09/546/003)
Maximum Dose
50 mg
Investigational Product Name
Simponi 50 mg solution for injection in pre-filled pen.
Active Substance
GOLIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (euMpNumber: PRD3353092)
Maximum Dose
50 mg
Investigational Product Name
Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
Active Substance
GOLIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (euMpNumber: PRD7075278)
Maximum Dose
45 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 (multiple national numbers included in dossier)
Maximum Dose
varies by formulation (maxTotalDoseAmount: 15)
Investigational Product Name
Jylamvo 2 mg/ml oral solution
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketingAuthNumber: EU/1/17/1172/001)
Maximum Dose
15 mg (maxTotalDoseAmount: 15)
Investigational Product Name
Methotrexate 2,5 mg film-coated tablets
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketingAuthNumber: AA084/05702)
Maximum Dose
varies (maxTotalDoseAmount: 15)
Investigational Product Name
Enbrel 50 mg solution for injection in pre-filled pen
Active Substance
ETANERCEPT
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/99/126/021)
Maximum Dose
dose per kg-based schedules (maxTotalDoseAmount: 0.8 mg/kg indicated in record)
Investigational Product Name
Enbrel 25 mg solution for injection in pre-filled syringe
Active Substance
ETANERCEPT
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthNumber: EU/1/99/126/013)
Maximum Dose
weight-based dosing (maxTotalDoseAmount: 0.8 mg/kg)
Investigational Product Name
Enbrel 25 mg solution for injection in pre-filled pen
Active Substance
ETANERCEPT
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (euMpNumber: PRD6538808)
Maximum Dose
weight-based (maxTotalDoseAmount: 0.8)
Investigational Product Name
Enbrel 50 mg solution for injection in pre-filled syringe
Active Substance
ETANERCEPT
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (euMpNumber: PRD6538802)
Maximum Dose
weight-based (maxTotalDoseAmount: 0.8)
Investigational Product Name
Olumiant 4 mg film-coated tablets
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (euMpNumber: PRD4760224)
Maximum Dose
4 mg
Investigational Product Name
Olumiant 1 mg film-coated tablets
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (euMpNumber: PRD10841783)
Maximum Dose
1 mg
Investigational Product Name
Olumiant 2 mg film-coated tablets
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (euMpNumber: PRD4760216)
Maximum Dose
2 mg

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