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Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT) (MYOCIT)

Primary Purpose

Juvenile Dermatomyositis

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Baricitinib

pharmacokinetics study

dosage of cytokines

transcriptomic analysis

Parent version of the Child Health Questionnaire (CHQ)

Childhood Health Assessment Questionnaire

Pregnancy test

About this trial

This is an interventional treatment trial for Juvenile Dermatomyositis focused on measuring juvenile dermatomyositis, baricitinib

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient aged 3-18 years with new-onset juvenile dermatomyositis, according to the ENMC 2018 dermatomyositis classification criteria
Muscle weakness at MMT and/or CMAS (MMT < 74 and/or CMAS < 45)
Seropositivity for chickenpox
For patients of childbearing age (following menarche) : Negative βHCG and effective method of contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until the 7 days after administration of the last dose of Baricitinib
Informed consent form signed by the patient or child' s parents Patient affiliated to a social security regime

Exclusion Criteria

Amyopathic dermatomyositis (without muscle weakness)
Inability to be treated by oral way or to take pills
Previous treatment with JAK inhibitor
Previous treatment of JDM with immunosuppressive drugs or biologics other than corticosteroids. Previous treatment with prednisone was allowed if the daily dose was greater than 1 mg/kg for no more than 1 month.
Previous history of cancer
Live vaccine within the 4 weeks before starting baricitinib therapy
Current, or recent (< 4 weeks prior to baseline) of active infections, including HBV, HCV, HIV, tuberculosis,
Positive blood CMV PCR
Creatinine clearance < 40 ml/min
Lymphocytes < 0,5x109 cell/L and Neutrophils < 1x109 cell/L
Hemoglobin < 8 g/dL
Symptomatic herpes herpes simplex infection within 12 weeks prior to inclusion
Positivity for antiphospholipids antibodies (Lupus anticoagulant and/or anti-beta2 glycoprotein 1 and/or anti-cardiolipin)
History of thrombosis or considered at high risk of venous thrombosis by the investigator
Presence of severe JDM-related involvements: cardiovascular (requiring vasopressive drug and/or intensive care unit), respiratory (requiring oxygen and/or intensive care unit), gastrointestinal (requiring abdominal surgery).
History of severe non-related JDM involvement: cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological or neuropsychiatric disorders or any other serious and/or instable illness that, in the opinion of the investigator, could constitute an unacceptable risk, when taking baricitinib.
Actual or in project of pregrancy and breast-feeding until the 7 days after administration of the last dose of Baricitinib
Patient on AME (state medical aid)
Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants

Sites / Locations

Hôpital PellegrinRecruiting
Hôpital Femme Mère EnfantRecruiting
Hôpital Jeanne de FlandreRecruiting
Hôpital La TimoneRecruiting
Hôpital Villeneuce
Hôpital BraboisRecruiting
Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologieRecruiting
Hôpital du Kremlin-BicêtreRecruiting
Hôpital Necker - Enfants malades : service de dermatologieRecruiting
Hôpital Robert DebréRecruiting
Hôpital TrousseauRecruiting
Hôpital de Hautepierre
Hôpital PurpanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Baricitinib

Arm Description

Outcomes

Primary Outcome Measures

PRINTO 20 (Paediatric Rheumatology INternational Trials Organisation scale)

Achievement of the validated juvenile dermatomyositis PRINTO 20 level of improvement. PRINTO 20 level of improvement is defined as a 20% or greater improvement in three or more of the six variables of the juvenile dermatomyositis core set, with one or no variable worsening by more than 30% (muscle strength can not be the variable worsening) : muscle strength, assessed with the Childhood Myositis Assessment Scale (CMAS), physician's global assessment of the patient's disease activity (Physician's VAS) global disease activity assessment through the Disease Activity Score (DAS) functional ability through the Childhood Health Assessment Questionnaire (C-HAQ) parent's global assessment of the child's overall wellbeing (Parent's VAS) health-related quality of life, through the parent version of the Child Health Questionnaire (CHQ-Phs) A higher score is 100% and means a better outcome, a lower score is 0% and means a worse result.

Secondary Outcome Measures

PRINTO 20 Paediatric Rheumatology INternational Trials Organisation scale - level 20

achievement of the validated juvenile dermatomyositis PRINTO 20 level ; reaching a minimum of 20 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

PRINTO 50 Paediatric Rheumatology INternational Trials Organisation scale - level 50

achievement of the validated juvenile dermatomyositis PRINTO 50 level ; reaching a minimum of 50 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

PRINTO 70 Paediatric Rheumatology INternational Trials Organisation scale - level 70

achievement of the validated juvenile dermatomyositis PRINTO 70 level ; reaching a minimum of 70 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

PRINTO 90 Paediatric Rheumatology INternational Trials Organisation scale - level 90

achievement of the validated juvenile dermatomyositis PRINTO 90 level ; reaching a minimum of 90 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

Total Improvement Score (TIS)

Relative and absolute variations of TIS. The TIS is the sum of the improvement in each of the six core set measures of disease activits The minimum score is 0 (worse) and maximum score is 100 (better) A major response is defined by a score > 70 A moderate response is defined by a score > 45 A minimal response is defined by a score > 30

Clinically inactive disease

according to the PRINTO criteria

Cutaneous Dermatomyositis Disease Area and Severity Index (CDSAI)

assess skin activity and damage across multiple body regions in patients with dermatomyositis

Myositis Disease Activity Assessment VAS (MYOACT)

Assess Relative and absolute variations of extramuscular activity

interstitial lung disease

Assessed by improvement of at least 10% of FCV, PTC, and DLCO and/or improvement of Lung tomodensitomery according to a specific scale

Dose of corticosteroid

Dose tapering at 6 months

Pharmacokinetics study

Non-compartmental analysis of baricitinib

Pharmacokinetics (PK) study with area under the curve

Correlation between area under the curve AUC in ng.h/ml (PK parameter of baricitinib) and disease activity 's scores

Pharmacokinetics (PK) study with maximal concentration

Correlation between maximal concentration Cmax in ng/mL (PK parameter of baricitinib) and disease activity 's scores

Pharmacokinetics (PK) study with through concentration

Correlation between through concentration Ctrough, in ng/mL (PK parameter of baricitinib) and disease activity 's scores

dosage of cytokines

Measurement of serum IFN -, IFN-γ, IL-1β, IL-4, Il-5, IL-6, IL-8, IL-10, IL-12p70, IL-22, TNF α

transcriptomic analysis

Study of genes expression within 800 genes related to immunity

Biopsy

Assessment of muscle biopsies according to the internationally validated score system

Full Information

NCT ID

NCT05524311

First Posted

July 5, 2022

Last Updated

September 4, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT05524311

Brief Title

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

Acronym

MYOCIT

Official Title

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 10, 2022 (Actual)

Primary Completion Date

May 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The MYOCIT study aims to evaluate the efficacy and safety of baricitinib in association with corticosteroids in new-onset patients with juvenile dermatomyositis (JDM) in a phase II trial with the objective to obtain a better efficacy than the conventional combination methotrexate (MTX) and corticosteroids over the 24 week study period. Thus, the investigators hypothesize that baricitinib could be used as a first line treatment in all forms of DMJ, including the most severe one, with a good safety profile.

Detailed Description

Juvenile dermatomyositis (JDM) is a rare and severe paediatric-onset idiopathic inflammatory myopathy, associated with significant morbidity and mortality. The combination of corticosteroids and methotrexate (MTX) is recommended in new-onset JDM according to one randomized trial. However, in this trial, treatment failures were reported in 13/46 (28%) patients and severe JDM, (cutaneous or gastrointestinal ulceration, interstitial pulmonary disease, cardiomyopathy) were not taken into account. These data emphasize the need for a more efficient first-line treatment. Considering: 1) the strong implication of type IFN-I in the pathophysiology of JDM 2) the report of the efficacy and safety of JAK inhibitors (JAKis) (baricitinb, tofacitinib) in about 50 refractory DM patients, and 9 JDM, a trial which evaluates the efficacy and safety of baricitinib in combination with corticosteroids in new-onset JDM is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Juvenile Dermatomyositis

Keywords

juvenile dermatomyositis, baricitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Baricitinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Intervention Description

Oral tablets (2 mg) will be used For children > or = 6 years: 4 mg once a day (2 x 2 mg) during the 24 weeks-period study For children < 6 years: 2 mg once a day during the 24 weeks -period study

Intervention Type

Biological

Intervention Name(s)

pharmacokinetics study

Intervention Description

additionnal blood sampling at week 4, 8, 12, and 24

Intervention Type

Biological

Intervention Name(s)

dosage of cytokines

Intervention Description

additionnal blood sampling at weeks 0, 4 and 24

Intervention Type

Biological

Intervention Name(s)

transcriptomic analysis

Intervention Description

additionnal blood sampling at weeks 0, 4 and 24

Intervention Type

Behavioral

Intervention Name(s)

Parent version of the Child Health Questionnaire (CHQ)

Intervention Description

Evaluate by parents at each visits

Intervention Type

Behavioral

Intervention Name(s)

Childhood Health Assessment Questionnaire

Intervention Description

Evaluate by parents at each visits

Intervention Type

Biological

Intervention Name(s)

Pregnancy test

Intervention Description

Urine pregnancy test at V4 A dosage of bHCG with current biological analysis is done at each visit (except V4)

Primary Outcome Measure Information:

Title

PRINTO 20 (Paediatric Rheumatology INternational Trials Organisation scale)

Description

Time Frame

At week 24

Secondary Outcome Measure Information:

Title

PRINTO 20 Paediatric Rheumatology INternational Trials Organisation scale - level 20

Description

achievement of the validated juvenile dermatomyositis PRINTO 20 level ; reaching a minimum of 20 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

Time Frame

At week 4, 8, 12 and 16

Title

PRINTO 50 Paediatric Rheumatology INternational Trials Organisation scale - level 50

Description

achievement of the validated juvenile dermatomyositis PRINTO 50 level ; reaching a minimum of 50 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

Time Frame

At week 4, 8, 12 and 16

Title

PRINTO 70 Paediatric Rheumatology INternational Trials Organisation scale - level 70

Description

achievement of the validated juvenile dermatomyositis PRINTO 70 level ; reaching a minimum of 70 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

Time Frame

At week 4, 8, 12 and 16

Title

PRINTO 90 Paediatric Rheumatology INternational Trials Organisation scale - level 90

Description

achievement of the validated juvenile dermatomyositis PRINTO 90 level ; reaching a minimum of 90 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result

Time Frame

At week 4, 8, 12 and 16

Title

Total Improvement Score (TIS)

Description

Time Frame

At inclusion, weeks 4, 8, 12, 16 and 24

Title

Clinically inactive disease

Description

according to the PRINTO criteria

Time Frame

At weeks 4, 8, 12 and 24

Title

Cutaneous Dermatomyositis Disease Area and Severity Index (CDSAI)

Description

assess skin activity and damage across multiple body regions in patients with dermatomyositis

Time Frame

At inclusion, weeks 4, 8, 12, 16 and 24

Title

Myositis Disease Activity Assessment VAS (MYOACT)

Description

Assess Relative and absolute variations of extramuscular activity

Time Frame

At inclusion, weeks 4, 8, 12, 16 and 24

Title

interstitial lung disease

Description

Assessed by improvement of at least 10% of FCV, PTC, and DLCO and/or improvement of Lung tomodensitomery according to a specific scale

Time Frame

At inclusion and at week 24

Title

Dose of corticosteroid

Description

Dose tapering at 6 months

Time Frame

At week 24

Title

Pharmacokinetics study

Description

Non-compartmental analysis of baricitinib

Time Frame

At weeks 4, 8, 12, and 24

Title

Pharmacokinetics (PK) study with area under the curve

Description

Correlation between area under the curve AUC in ng.h/ml (PK parameter of baricitinib) and disease activity 's scores

Time Frame

At weeks 4, 8, 12, and 24

Title

Pharmacokinetics (PK) study with maximal concentration

Description

Correlation between maximal concentration Cmax in ng/mL (PK parameter of baricitinib) and disease activity 's scores

Time Frame

At weeks 4, 8, 12, and 24

Title

Pharmacokinetics (PK) study with through concentration

Description

Correlation between through concentration Ctrough, in ng/mL (PK parameter of baricitinib) and disease activity 's scores

Time Frame

At weeks 4, 8, 12, and 24

Title

dosage of cytokines

Description

Measurement of serum IFN -, IFN-γ, IL-1β, IL-4, Il-5, IL-6, IL-8, IL-10, IL-12p70, IL-22, TNF α

Time Frame

At inclusion, weeks 4 and 24

Title

transcriptomic analysis

Description

Study of genes expression within 800 genes related to immunity

Time Frame

At inclusion, weeks 4 and 24

Title

Biopsy

Description

Assessment of muscle biopsies according to the internationally validated score system

Time Frame

At inclusion, weeks 4 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient aged 3-18 years with new-onset juvenile dermatomyositis, according to the ENMC 2018 dermatomyositis classification criteria Muscle weakness at MMT and/or CMAS (MMT < 74 and/or CMAS < 45) Seropositivity for chickenpox For patients of childbearing age (following menarche) : Negative βHCG and effective method of contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until the 7 days after administration of the last dose of Baricitinib Informed consent form signed by the patient or child' s parents Patient affiliated to a social security regime Exclusion Criteria Amyopathic dermatomyositis (without muscle weakness) Inability to be treated by oral way or to take pills Previous treatment with JAK inhibitor Previous treatment of JDM with immunosuppressive drugs or biologics other than corticosteroids. Previous treatment with prednisone was allowed for no more than 1 month. Previous history of cancer Live vaccine within the 4 weeks before starting baricitinib therapy Current, or recent (< 4 weeks prior to baseline) of active infections according to investigator appreciation, but necessarily, including HBV, HCV, HIV, tuberculosis. Positive blood CMV PCR Creatinine clearance < 40 ml/min Lymphocytes < 0,5x109 cell/L and Neutrophils < 1x109 cell/L Hemoglobin < 8 g/dL Symptomatic herpes herpes simplex infection within 12 weeks prior to inclusion History of thrombosis or considered at high risk of venous thrombosis by the investigator Presence of severe JDM-related involvements: cardiovascular (requiring vasopressive drug and/or intensive care unit), respiratory (requiring oxygen and/or intensive care unit), gastrointestinal (requiring abdominal surgery). History of severe non-related JDM involvement: cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological or neuropsychiatric disorders or any other serious and/or instable illness that, in the opinion of the investigator, could constitute an unacceptable risk, when taking baricitinib. Actual or in project of pregrancy and breast-feeding until the 7 days after administration of the last dose of Baricitinib Patient on AME (state medical aid) Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brigitte BADER-MEUNIER, Doctor

Phone

01 44 49 43 32

brigitte.bader-meunier@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Laure CHOUPEAUX, MSc

Phone

01 44 38 17 11

laure.choupeaux@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cyril GITIAUX, Doctor

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Study Director

Facility Information:

Facility Name

Hôpital Pellegrin

City

Bordeaux

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal PILLET, Docteur

pascal.pillet@chu-bordeaux.fr

Facility Name

Hôpital Femme Mère Enfant

City

Bron

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre BELOT, Professeur

alexandre.belot@chu-lyon.fr

Facility Name

Hôpital Jeanne de Flandre

City

Lille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Héloïse REUMAUX, Docteur

heloise.remaux@chu-lille.fr

Facility Name

Hôpital La Timone

City

Marseille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédérique AUDIC, Docteur

frederique.audic@ap-hm.Fr

Facility Name

Hôpital Villeneuce

City

Montpellier

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurélia CARBASSE, Docteur

a-carbasse@chu-montpellier.fr

Facility Name

Hôpital Brabois

City

Nancy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irène LEMELLE, Docteur

i.lemelle@chru-nancy.fr

Facility Name

Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologie

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brigitte BADER-MEUNIER, Docteur

brigitte.bader-meunier@aphp.fr

Facility Name

Hôpital du Kremlin-Bicêtre

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle KONE-PAUT, Professeur

isabelle.kone-paut@aphp.fr

Facility Name

Hôpital Necker - Enfants malades : service de dermatologie

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne WELFRINGER, Professeur

anne.welfringer@aphp.fr

Facility Name

Hôpital Robert Debré

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle MELKI, Docteur

isabelle.melki@aphp.fr

Facility Name

Hôpital Trousseau

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud ISAPOF, Docteur

arnaud.isapof@aphp.fr

Facility Name

Hôpital de Hautepierre

City

Strasbourg

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain MEYER, Docteur

alain.meyer1@chru-strasbourg.fr

Facility Name

Hôpital Purpan

City

Toulouse

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karine BROCHARD, Docteur

brouchard.k@chu-toulouse.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

18163404

Citation

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Results Reference

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Citation

Lazarevic D, Pistorio A, Palmisani E, Miettunen P, Ravelli A, Pilkington C, Wulffraat NM, Malattia C, Garay SM, Hofer M, Quartier P, Dolezalova P, Penades IC, Ferriani VP, Ganser G, Kasapcopur O, Melo-Gomes JA, Reed AM, Wierzbowska M, Rider LG, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). The PRINTO criteria for clinically inactive disease in juvenile dermatomyositis. Ann Rheum Dis. 2013 May;72(5):686-93. doi: 10.1136/annrheumdis-2012-201483. Epub 2012 Jun 26.

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Citation

Bode RK, Klein-Gitelman MS, Miller ML, Lechman TS, Pachman LM. Disease activity score for children with juvenile dermatomyositis: reliability and validity evidence. Arthritis Rheum. 2003 Feb 15;49(1):7-15. doi: 10.1002/art.10924.

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Citation

Giancane G, Lavarello C, Pistorio A, Oliveira SK, Zulian F, Cuttica R, Fischbach M, Magnusson B, Pastore S, Marini R, Martino S, Pagnier A, Soler C, Stanevicha V, Ten Cate R, Uziel Y, Vojinovic J, Fueri E, Ravelli A, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). The PRINTO evidence-based proposal for glucocorticoids tapering/discontinuation in new onset juvenile dermatomyositis patients. Pediatr Rheumatol Online J. 2019 May 22;17(1):24. doi: 10.1186/s12969-019-0326-5.

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Citation

Mammen AL, Allenbach Y, Stenzel W, Benveniste O; ENMC 239th Workshop Study Group. 239th ENMC International Workshop: Classification of dermatomyositis, Amsterdam, the Netherlands, 14-16 December 2018. Neuromuscul Disord. 2020 Jan;30(1):70-92. doi: 10.1016/j.nmd.2019.10.005. Epub 2019 Oct 25. No abstract available.

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Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

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