Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
150
Countries
1
Sites
7
Juvenile Idiopathic Arthritis
To assess the effect of two different treatment withdrawal strategies, compared to stable dose of methotrexate and tumor necrosis factor inhibitor (TNFi), on the risk of flares in children and adolescents with juvenile idiopathic arthritis in sustained inactive disease*. *Sustained inactive disease is defined as clinic…
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], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 24 Oct 2024 → ongoing
- Decision date (initial)
- 2024-08-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Helse Sør-Øst · Norges Forskningsråd
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
To assess the effect of two different treatment withdrawal strategies, compared to stable dose of methotrexate and tumor necrosis factor inhibitor (TNFi), on the risk of flares in children and adolescents with juvenile idiopathic arthritis in sustained inactive disease*.
*Sustained inactive disease is defined as clinically judged inactive disease by treating physician at all appointments at least 12 months prior to inclusion AND inactive disease (Wallace) at inclusion to the study.
Secondary objectives 4
- To assess the risk of flares between two different treatment withdrawals strategies in children and adolescents with juvenile idiopathic arthritis with sustained inactive disease.
- To assess time to flare, and time to regain inactive disease after flare
- To compare changes in disease activity in the different treatment arms
- To assess overall safety
Conditions and MedDRA coding
Juvenile Idiopathic Arthritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Fulfilment of the ILAR classification criteria for non-systemic JIA; 2 to <18 years of age at the time of signing the informed consent; sustained clinical remission for ≥12 months documented at a minimum of 2 visits during the last 18 months and Wallace inactive disease at inclusion; no active uveitis for ≥24 months; stable treatment with TNF-inhibitor and methotrexate for ≥3 months.
Exclusion criteria 1
- Corticosteroid use (including intra-articular injections) at the indication of JIA less than 6 months prior to randomization; chronic widespread pain syndrome.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The primary outcomes of this study are the proportion of study participants with a disease flare* during the first 12 months follow-up compared between each of the two drug withdrawal arms and the stable treatment arm.
- *Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic (DMARD) treatment.
Secondary endpoints 4
- The proportion of study participants with a disease flare* during the first 12 months follow-up compared between the two drug withdrawal arms.
- Time to flare and time to regain inactive disease after flare
- Changes in validated measures of disease activity
- Reports of adverse events, serious adverse events and suspected unexpected adverse reactions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- TABLETS
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 3.57 mg milligram(s)
- Max total dose
- 3900 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01984MIG · Substance
- Active substance
- Etanercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 7.2 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 3900 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25638 · Substance
- Active substance
- Golimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 3.3 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 3900 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 5.7 mg milligram(s)
- Max total dose
- 6240 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- Anna-Birgitte Aga
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Anna-Birgitte Aga
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 150 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Vestre Viken HF
Drammen Hospital, Vestre Viken, Revmatologi, Dronninggata 28, 3004, Drammen
Universitetssykehuset Nord-Norge HF
Revmatologi, Hansine Hansens Veg 67, 9019, Tromsoe
Helse Bergen HF
Revmatologi, Haukelandsveien 22, 5021, Bergen
Oslo University Hospital HF
Seksjon for Revmatologi, Sognsvannsveien 20, 0372, Oslo
Helse Stavanger HF
Revmatologi, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
St. Olavs Hospital HF
Revmatologi, P. O. Box 3250, Torgarden, Trondheim
Sørlandet sykehus Kristiansand
Revmatologi, Egsveien 100, 4615, Kristiansand
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2024-10-24 | 2024-10-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-513017-12-00_not for publication | 1.2 |
| Protocol (for publication) | D1_Protocol_2024-513017-12-00- for publication | 1.2 |
| Protocol (for publication) | D1_Protocol_Sponsor signature page-signed_2024-513017-12-00 | 1.2 |
| Protocol (for publication) | Protocol_MOVE JIA_V1_2_track changes | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2024-513017-12-00 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2024-513017-12-00 track changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_12-16_2024-513017-12-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_12-16_2024-513017-12-00_track changes | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_16-18_2024-513017-12-00 | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_16-18_2024-513017-12-00_track changes | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adults_2024-513017-12-00 | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adults_2024-513017-12-00 060524 track changes | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_under 12 yr_2024-513017-12-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Adalimumab_Humira 20 mg_2024-513017-12-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Etanercept_enbrel 25 mg_2024-513017-12-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Golimumab_simponi_2024-513017-12-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Methotrexate_mixture_2024-513017-12-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Methotrexate_nordimet_2024-513017-12-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Methotrexate_tablets_norwegian_2024-513017-12-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2024-513017-12-00 080524 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-10 | Norway | Acceptable with conditions 2024-08-23
|
2024-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-06 | Norway | Acceptable 2025-06-12
|
2025-06-26 |