Toward personalized medicine to guide drug withdrawal in children with juvenile idiopathic arthritis in clinical remission: a randomized clinical trial comparing early versus late drug withdrawal combining imaging and multi-Omics.

2024-514732-24-00 Protocol Re-JIA Therapeutic use (Phase IV) Authorised, recruiting

Start 28 Apr 2025 · Status Authorised, recruiting · 7 EU/EEA countries · 24 sites · Protocol Re-JIA

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruiting
Participants planned 328
Countries 7
Sites 24

Juvenile idiopathic arthritis

To demonstrate that early biomarker-guided withdrawal of antirheumatic agents in JIA patients achieving 6 months clinical inactive disease (CID) with medication and who do not have subclinical inflammation is safe and more effective when compared to the standard practice of maintenance of stable treatment intensity ove…

Key facts

Sponsor
IRCCS Istituto Giannina Gaslini
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20]
Trial duration
28 Apr 2025 → ongoing
Decision date (initial)
2024-10-31
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Italian Ministry of Health, Project Code: PNRR-MCNT2-2023-12378373

External identifiers

EU CT number
2024-514732-24-00
ClinicalTrials.gov
NCT06618937

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate that early biomarker-guided withdrawal of antirheumatic agents in JIA patients achieving 6 months clinical inactive disease (CID) with medication and who do not have subclinical inflammation is safe and more effective when compared to the standard practice of maintenance of stable treatment intensity over 12 months.

Secondary objectives 1

  1. Biological (blood) samples will be collected and analysed by adopting multi-Omics approaches with the aim of accelerating the discovery of novel biomarkers able to predict flare after treatment withdrawal. Increased access to these immunologic and transcriptomic profiling technologies could significantly support clinicians in identifying patients who are candidates for successful medication withdrawal.

Conditions and MedDRA coding

Juvenile idiopathic arthritis

VersionLevelCodeTermSystem organ class
23.1 PT 10059176 Juvenile idiopathic arthritis 100000004859

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Children with JIA according to the ILAR classification (Oligoarthritis, Rheumatoid factor negative polyarthritis, Rheumatoid factor positive polyarthritis, Psoriatic arthritis, Enthesitis-related arthritis)
  2. JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.
  3. JIA patients who are receiving cs/b/bs/tsDMARDs according to the label indication.
  4. 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
  5. Duly executed, written, informed consent obtained from the patient’s parents/legal guardian.
  6. 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 9

  1. Patients with systemic JIA according to ILAR criteria
  2. Patients with undifferentiated arthritis according to ILAR criteria
  3. Patients with severe disease-related ocular damage and who need systemic treatment for uveitis
  4. Patients who had received glucocorticoid treatment 3 months prior to baseline visit
  5. Patients who had previously unsuccessfully attempted tapering cs/b/bs/tsDMARDs
  6. Patients with severe damage as per caring physician measured
  7. 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.
  8. Pregnant and breastfeeding individuals
  9. Participation in other interventional clinical trials for the entire duration of the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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.

Secondary endpoints 1

  1. Time to Flare: time from randomization to flare

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 34

ORENCIA 250 mg powder for concentrate for solution for infusion

PRD2316712 · Product

Active substance
Abatacept
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0.36 mg/kg milligram(s)/kilogram
Max total dose
10 mg/kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA24 — -
Marketing authorisation
EU/1/07/389/003
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ORENCIA 125 mg solution for injection in pre-filled syringe

PRD2316715 · Product

Active substance
Abatacept
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
17.86 mg milligram(s)
Max total dose
125 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA24 — -
Marketing authorisation
EU/1/07/389/006
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003609 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
1.43 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171446
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003898 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2.86 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/square meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171461
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate 2,5 mg film-coated tablets

PRD10040098 · Product

Active substance
Methotrexate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2.5 mg milligram(s)
Max total dose
15 m2 square meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L01BA01 — METHOTREXATE
Marketing authorisation
AA084/05702
MA holder
REMEDICA LTD
MA country
Malta
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003613 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
1.79 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/square meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171535
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003894 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2.5 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171550
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Jylamvo 2 mg/ml oral solution

PRD4935922 · Product

Active substance
Methotrexate
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL
Max daily dose
2 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
EU/1/17/1172/001
MA holder
THERAKIND (EUROPE) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003902 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
3.21 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171574
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003605 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
1.1 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/square meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171434
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003906 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
3.57 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/square meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171473
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Reumaflex 50 mg/ml soluzione iniettabile, siringa preriempita

PRD11003618 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2.14 mg milligram(s)
Max total dose
15 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
045171699
MA holder
ALFASIGMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2154624 · Product

Active substance
Tocilizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0.36 mg/kg milligram(s)/kilogram
Max total dose
10 mg/Kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC07 — -
Marketing authorisation
EU/1/08/492/005
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2154620 · Product

Active substance
Tocilizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0.36 mg/Kg milligram(s)/kilogram
Max total dose
10 mg/Kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC07 — -
Marketing authorisation
EU/1/08/492/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2154622 · Product

Active substance
Tocilizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0.36 mg/kg milligram(s)/kilogram
Max total dose
10 mg/kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC07 — -
Marketing authorisation
EU/1/08/492/003
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

RoActemra 162 mg solution for injection in pre-filled pen.

PRD6143596 · Product

Active substance
Tocilizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
11.57 mg milligram(s)
Max total dose
162 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC07 — -
Marketing authorisation
EU/1/08/492/010
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 150 mg solution for injection in pre-filled syringe

PRD2398835 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
5.36 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 75 mg solution for injection in pre-filled syringe

PRD9061364 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2.68 mg milligram(s)
Max total dose
75 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/012
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cosentyx 150 mg solution for injection in pre-filled pen

PRD4384703 · Product

Active substance
Secukinumab
Substance synonyms
Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
5.36 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AC10 — -
Marketing authorisation
EU/1/14/980/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enbrel 50 mg solution for injection in pre-filled pen

PRD6538809 · Product

Active substance
Etanercept
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0.11 mg/kg milligram(s)/kilogram
Max total dose
0.8 mg/kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB01 — -
Marketing authorisation
EU/1/99/126/021
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enbrel 25 mg solution for injection in pre-filled syringe

PRD6538806 · Product

Active substance
Etanercept
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0.11 mg/kg milligram(s)/kilogram
Max total dose
0.8 mg/kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB01 — -
Marketing authorisation
EU/1/99/126/013
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enbrel 25 mg solution for injection in pre-filled pen

PRD6538808 · Product

Active substance
Etanercept
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0.11 mg/kg milligram(s)/kilogram
Max total dose
0.8 mg/Kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB01 — -
Marketing authorisation
EU/1/99/126/023
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enbrel 50 mg solution for injection in pre-filled syringe

PRD6538802 · Product

Active substance
Etanercept
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0.11 mg/kg milligram(s)/kilogram
Max total dose
0.8 mg/kg milligram(s)/kilogram
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB01 — -
Marketing authorisation
EU/1/99/126/017
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Simponi 50 mg solution for injection in pre-filled syringe.

PRD3349081 · Product

Active substance
Golimumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS
Max daily dose
1.43 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB06 — -
Marketing authorisation
EU/1/09/546/003
MA holder
JANSSEN BIOLOGICS B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Simponi 50 mg solution for injection in pre-filled pen.

PRD3353092 · Product

Active substance
Golimumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
1.43 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB06 — -
Marketing authorisation
EU/1/09/546/002
MA holder
JANSSEN BIOLOGICS B.V.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.

PRD7075278 · Product

Active substance
Golimumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
1.61 mg milligram(s)
Max total dose
45 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB06 — -
Marketing authorisation
EU/1/09/546/009
MA holder
JANSSEN BIOLOGICS B.V.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

XELJANZ 1 mg/mL oral solution

PRD9172022 · Product

Active substance
Tofacitinib
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA29 — -
Marketing authorisation
EU/1/17/1178/015
MA holder
PFIZER EUROPE MA EEIG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

XELJANZ 5 mg film-coated tablets

PRD4862227 · Product

Active substance
Tofacitinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA29 — -
Marketing authorisation
EU/1/17/1178/002
MA holder
PFIZER EUROPE MA EEIG
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Olumiant 4 mg film-coated tablets

PRD4760224 · Product

Active substance
Baricitinib
Substance synonyms
LY-3009104, INCB-028050
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
4 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA37 — -
Marketing authorisation
EU/1/16/1170/009
MA holder
ELI LILLY NEDERLAND B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Olumiant 1 mg film-coated tablets

PRD10841783 · Product

Active substance
Baricitinib
Substance synonyms
LY-3009104, INCB-028050
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 mg milligram(s)
Max total dose
1 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA37 — -
Marketing authorisation
EU/1/16/1170/017
MA holder
ELI LILLY NEDERLAND B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Olumiant 2 mg film-coated tablets

PRD4760216 · Product

Active substance
Baricitinib
Substance synonyms
LY-3009104, INCB-028050
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AA37 — -
Marketing authorisation
EU/1/16/1170/001
MA holder
ELI LILLY NEDERLAND B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Humira 40 mg solution for injection in pre-filled pen

PRD5952361 · Product

Active substance
Adalimumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2.86 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB04 — -
Marketing authorisation
EU/1/03/256/007
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Humira 40 mg solution for injection in pre-filled syringe

PRD5952356 · Product

Active substance
Adalimumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
2.86 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB04 — -
Marketing authorisation
EU/1/03/256/002
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Humira 20 mg solution for injection in pre-filled syringe

PRD5957074 · Product

Active substance
Adalimumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
1.43 mg milligram(s)
Max total dose
20 mg milligram(s)
Max treatment duration
21 Month(s)
Authorisation status
Authorised
ATC code
L04AB04 — -
Marketing authorisation
EU/1/03/256/022
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IRCCS Istituto Giannina Gaslini

8 Total trials 4 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
IRCCS Istituto Giannina Gaslini
Address
Via Gerolamo Gaslini 5
City
Genoa
Postcode
16147
Country
Italy

Scientific contact point

Organisation
IRCCS Istituto Giannina Gaslini
Contact name
Clara Malattia

Public contact point

Organisation
IRCCS Istituto Giannina Gaslini
Contact name
Clara Malattia

Locations

7 EU/EEA countries · 24 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Authorised, recruitment pending 15 1
Czechia Authorised, recruitment pending 2 1
Denmark Not authorised 15 1
Italy Ongoing, recruiting 288 16
Lithuania Authorised, recruitment pending 2 2
Portugal Authorised, recruitment pending 2 1
Spain Authorised, recruitment pending 4 2
Rest of world — 0 —

Investigational sites

Belgium

1 site · Authorised, recruitment pending
Antwerp University Hospital
Pediatrics, Drie Eikenstraat 655, 2650, Edegem

Czechia

1 site · Authorised, recruitment pending
Fakultni Nemocnice V Motole
Paediatric Department, V Uvalu 84/1, Motol, Prague

Denmark

1 site · Not authorised
Aarhus Universitetshospital
Pediatric rheumatology unit, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Italy

16 sites · Ongoing, recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Materno Infantile, UO Nefrologia e Reumatologia Pediatrica, Via Consolare Valeria N 1, 98124, Messina
Azienda Ospedaliera Universitaria Meyer IRCCS
Dipartimento di Pediatria, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Clinica Pediatrica, Via Santa Sofia 78, 95123, Catania
Azienda Unita Sanitaria Locale Della Romagna
Divisione di Pediatria, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Pediatria, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Delle Marche
Divisione di Pediatria, Via Conca 71, 60126, Ancona
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Pediatric Rheumatology, Via Della Commenda 12, 20122, Milan
Universita' Degli Studi G. D'Annunzio Di Chieti
Dipartimento di Pediatria, Via Dei Vestini 31, 66100, Chieti
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Salute della Donna, del Bambino e dell'Adolescente, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
F.Fede Rheumatology Department, Piazza Luigi Miraglia 2, 80138, Naples
ASST Fatebenefratelli Sacco
Pediatric Rheumatology Unit, Department of Childhood and Developmental Medicine, Piazzale Principessa Clotilde 3, 20121, Milan
Azienda Ospedaliero Universitaria Renato Dulbecco
UOC Pediatria Specialistica e Malattie Rare, Viale Europa, 88100, Catanzaro
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Scienze della Riproduzione e dello Sviluppo, Via Dell' Istria 65/1, 34137, Trieste
IRCCS Istituto Giannina Gaslini
Reumatologia e Malattie Autoinfiammatorie, Via Gerolamo Gaslini 5, 16147, Genoa
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Divisione di Reumatologia, Piazza Cardinale Andrea Ferrari 1, 20122, Milan
Ospedale Vito Fazzi Lecce
UOSD Reumatologia e Immunologia Pediatrica, Piazza Filippo Muratore 1, 73100, Lecce

Lithuania

2 sites · Authorised, recruitment pending
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Centre of Pediatrics, Santariskiu G. 7, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Paediatric Department, Eiveniu G. 2, Kauno M. Sav., Kaunas

Portugal

1 site · Authorised, recruitment pending
Unidade Local De Saude De Almada-Seixal E.P.E.
Rheumatology, Avenida Torrado Da Silva, 2805-267, Almada

Spain

2 sites · Authorised, recruitment pending
Complexo Hospitalario Universitario De Santiago
Rheumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Y Politecnico La Fe
Department of Pediatric Rheumatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2025-04-28 2025-04-28

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 87 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-514732-24_SM-1 3
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Subject information and informed consent form (for publication) L1_Letter to treating physician_EN 1
Subject information and informed consent form (for publication) L1_Letter to treating physician_EN 1
Subject information and informed consent form (for publication) L1_Letter to treating physician_EN 2
Subject information and informed consent form (for publication) L1_Letter to treating physician_EN 2
Subject information and informed consent form (for publication) L1_Letter to treating physician_EN 2
Subject information and informed consent form (for publication) L1_Letter to treating physician_EN 1
Subject information and informed consent form (for publication) L1_Letter to treating physician_IT 1
Subject information and informed consent form (for publication) L1_Letter to treating physician_LT 3
Subject information and informed consent form (for publication) L1_Letter to treating physician_NL 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_CZ 3
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_DK 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_ES 3
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_IT 2
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_LT 3
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_NL 1
Subject information and informed consent form (for publication) L1_SIS and ICF 12-17 yr_PT 2
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr LT 3
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr_CZ 2
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr_DK 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr_ES 3
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr_IT 2
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr_NL 1
Subject information and informed consent form (for publication) L1_SIS and ICF 6-11 yr_PT 2
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_CZ 3
Subject information and informed consent form (for publication) L1_SIS and ICF adults_DK 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_ES 3
Subject information and informed consent form (for publication) L1_SIS and ICF adults_IT 2
Subject information and informed consent form (for publication) L1_SIS and ICF adults_LT 3
Subject information and informed consent form (for publication) L1_SIS and ICF adults_NL 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_PT 2
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian 1
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian 1
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian 1
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian 1
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian 1
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian_LT 3
Subject information and informed consent form (for publication) L1_SIS and ICF parent-guardian_NL 1
Subject information and informed consent form (for publication) L1_SIS and ICF parents-legal guardian_CZ 3
Subject information and informed consent form (for publication) L1_SIS and ICF parents-legal guardian_DK 1
Subject information and informed consent form (for publication) L1_SIS and ICF parents-legal guardian_ES 3
Subject information and informed consent form (for publication) L1_SIS and ICF parents-legal guardian_IT 2
Subject information and informed consent form (for publication) L1_SIS and ICF parents-legal guardian_PT 2
Subject information and informed consent form (for publication) L1_SIS and ICF Privacy_adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF Privacy_parents_legal guardian 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_cosentyx 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_enbrel 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_humira 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_jylamvo 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_Methotrexate 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_olumiant 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_orencia 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_Reumaflex 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_roactemra 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_simponi 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC_xeljanz 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_DE 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_LT 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_NL 2024-514732-24-00 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_PT 2024-514732-24-00 2

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-03 Italy Acceptable
2024-10-28
 2024-10-29
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-02-25 Italy Acceptable
2024-10-28
 2025-02-25
3 SUBSTANTIAL MODIFICATION SM-1 2025-05-21 Italy Acceptable
2025-07-21
 2025-07-25

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