Clinical trial • Phase IV • Musculoskeletal | Immunology
ADALIMUMAB for Juvenile idiopathic arthritis
Phase IV trial of ADALIMUMAB for Juvenile idiopathic arthritis.
Overview
- Trial Therapeutic Area
- Musculoskeletal | Immunology
- Trial Disease
- Juvenile idiopathic arthritis
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody | Other antibody | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 10-05-2024
- First CTIS Authorization Date
- 28-08-2024
Trial design
Randomised, open-label, continued stable treatment with methotrexate and tumor necrosis factor inhibitor (tnfi) (stable treatment arm). doses and schedules are not specified in the available data.-controlled Phase IV trial across 7 sites in Norway.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Continued stable treatment with methotrexate and tumor necrosis factor inhibitor (TNFi) (stable treatment arm). Doses and schedules are not specified in the available data.
- Target Sample Size
- 150
- Trial Duration For Participant
- 365
Eligibility
Recruits 150 paediatric patients.
- Vulnerable Population
- Children and adolescents (age range 2 to <18 years) are included and 'isVulnerablePopulationSelected' is true. Age-specific subject information and informed consent forms are provided (documents: 'L1_ SIS and ICF_under 12 yr', 'L1_ SIS and ICF_12-16', 'L1_ SIS and ICF_16-18', 'L1_ SIS and ICF_Adults'). Specific consent/assent wording or language options are not provided in the available data.
Inclusion criteria
- {"criterion_text":"- Fulfilment of the ILAR classification criteria for non-systemic JIA"}
- {"criterion_text":"- 2 to <18 years of age at the time of signing the informed consent"}
- {"criterion_text":"- sustained clinical remission for ≥12 months documented at a minimum of 2 visits during the last 18 months and Wallace inactive disease at inclusion"}
- {"criterion_text":"- no active uveitis for ≥24 months"}
- {"criterion_text":"- stable treatment with TNF-inhibitor and methotrexate for ≥3 months"}
Exclusion criteria
- {"criterion_text":"- Corticosteroid use (including intra-articular injections) at the indication of JIA less than 6 months prior to randomization"}
- {"criterion_text":"- chronic widespread pain syndrome"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of participants experiencing a disease flare during the first 12 months of follow-up, compared between each withdrawal arm and the stable treatment arm."}
- {"endpoint_text":"- *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.","definition_or_measurement_approach":"Disease flare defined as: (1) increase in JADAS-27 ≥1.7 from baseline AND ≥1 active joint (swollen or tender + limited range of motion) OR (2) consensus between treating physician and participant/parents that a clinically significant flare has occurred requiring intensification of DMARD treatment."}
Secondary endpoints
- {"endpoint_text":"- The proportion of study participants with a disease flare* during the first 12 months follow-up compared between the two drug withdrawal arms.","definition_or_measurement_approach":"Proportion of participants with disease flare during first 12 months in the two withdrawal arms (comparison between withdrawal arms)."}
- {"endpoint_text":"- Time to flare and time to regain inactive disease after flare","definition_or_measurement_approach":"Time-to-event measures (time to flare; time from flare to regaining inactive disease). Specific censoring rules or precise definitions not provided in available data."}
- {"endpoint_text":"- Changes in validated measures of disease activity","definition_or_measurement_approach":"Change from baseline in validated disease activity measures (specific instruments beyond JADAS-27 not detailed in the available data)."}
- {"endpoint_text":"- Reports of adverse events, serious adverse events and suspected unexpected adverse reactions","definition_or_measurement_approach":"Safety reporting of AEs, SAEs, and SUSARs according to standard pharmacovigilance procedures; detailed definitions and time windows not provided in the available data."}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 71
- Consent Approach
- Age-specific subject information and informed consent forms are provided: 'L1_ SIS and ICF_under 12 yr', 'L1_ SIS and ICF_12-16', 'L1_ SIS and ICF_16-18', and 'L1_ SIS and ICF_Adults'. The trial includes participants aged 2 to <18 years; specific details on who provides consent (e.g., parent/guardian) or assent wording and available languages are not specified in the available data.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 150
Norway
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 26-06-2025
- Processing Time Days
- 323
- Number Of Sites
- 7
- Number Of Participants
- 150
Sites
- Site Name
- Vestre Viken HF
- Department Name
- Drammen Hospital, Vestre Viken, Revmatologi
- Contact Person Name
- Cathrine Austad
- Contact Person Email
- cataus@vestreviken.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Seksjon for Revmatologi
- Contact Person Name
- Siri Opsahl Hetlevik
- Contact Person Email
- Siri.Opsahl.Hetlevik@ous-hf.no
- Site Name
- Helse Bergen HF
- Department Name
- Revmatologi
- Contact Person Name
- Maria Karolina Jonsson
- Contact Person Email
- maria.karolina.jonsson@helse-bergen.no
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Revmatologi
- Contact Person Name
- Ellen Berit Nordal
- Contact Person Email
- Ellen.Berit.Nordal@unn.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Revmatologi
- Contact Person Name
- Marite Rygg
- Contact Person Email
- marite.rygg@ntnu.no
- Site Name
- Sørlandet sykehus Kristiansand
- Department Name
- Revmatologi
- Contact Person Name
- Hege Kilander Høiberg
- Contact Person Email
- hegekilander@gmail.com
- Site Name
- Helse Stavanger HF
- Department Name
- Revmatologi
- Contact Person Name
- Maria Bilstad
- Contact Person Email
- maria.bilstad@sus.no
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- ADALIMUMAB
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (prodAuthStatus: 2)
- Investigational Product Name
- ETANERCEPT
- Active Substance
- ETANERCEPT
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (prodAuthStatus: 2)
- Investigational Product Name
- GOLIMUMAB
- Active Substance
- GOLIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (prodAuthStatus: 2)
- Investigational Product Name
- METHOTREXATE
- Active Substance
- METHOTREXATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL | SUBCUTANEOUS (multiple formulations listed: tablets, oral solution, injection)
- Route
- ORAL or SUBCUTANEOUS depending on formulation
- Authorisation Status
- Authorised (prodAuthStatus: 2)
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.