The My-JIA trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

1 Dec 2020 → 6 Feb 2025

Decision date (initial)

2024-05-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

The Norwegian Women's Public Health Association · Southern and Eastern Norway Regional Health Authority · The children's foundation, Oslo University Hospital · The research council of Norway · Norwegian rheumatism association

External identifiers

EU CT number

2023-510118-21-00

EudraCT number

2019-000889-38

ClinicalTrials.gov

NCT04614311

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy, Efficacy, Safety

To assess if concomitant intra-articular glucocorticoid injections of joints with active arthritis in JIA patients starting Tumour Necrosis Factor (TNF) inhibitor (TNFi) treatment increase the proportion of JIA patients reaching sustained, inactive disease, when compared to the control group not receiving joint injections.

Secondary objectives 1

1. To compare the efficacy of the two treatment regimens up to 24 weeks of follow-up.

Conditions and MedDRA coding

Juvenile Idiopathic Arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1-18 years of age at the time of signing the informed consent.
2. Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA.
3. Clinical indication for starting TNFi treatment according to consensus between at least two physicians.
4. Naïve to TNFi or prior use of one TNFi (stopped at least 3 months before study inclusion and no previous TNFi treatment failure).
5. Juvenile Disease Activity Score (JADAS) >1 at baseline and at least one joint with active arthritis were joint injection is considered.
6. Willing to give written consent (participant ≥ 16, guardians if < 16 years of age, both participants and guardians if 16-18) and comply with the requirements of the study protocol.

Exclusion criteria 13

1. Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
2. Used two or more TNFi.
3. Corticosteroid use (including i.a. injection) less than 4 weeks prior to randomisation.
4. Known hypersensitivity to Triamcinolone hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol).
5. Concomitant therapy with CYP3A-inhibitors or digitalis glycosides.
6. Known inherited fructose intolerance
7. Presence of hepatitis B surface antigen (HBsAg) at screening.
8. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.
9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (front), and TB testing. The choice of TB tests will be made by the investigator according to local licensing and standard of care.
10. Having received live vaccines less than two weeks prior to randomisation.
11. Drug / alcohol abuse which hampers adherence to the study protocol.
12. Language barriers that hampers adherence to the study protocol.
13. Pregnancy or breast-feeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of participants with sustained, inactive disease (according to the Wallace 2011 criteria) and no i.a. or p.o. glucocorticoid use from week 24 to 36.

Secondary endpoints 1

1. 30% improvement in the paediatric American College of Rheumatology criteria (ACR Pedi 30 improvement) at week 24.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Jorunn Hagen Rønsen

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Pernille Bøyesen

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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