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Safety, tolerability, pharmacokinetics, and efficacy of filgotinib for the treatment of polyarticular-course juvenile idiopathic arthritis in children and adolescents
EU CTIS ID: 2024-511593-70-00
What this study is testing
The main aim of the study is to evaluate the safety, tolerability, PK, and efficacy of filgotinib in subjects with pJIA.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening evaluations.
- Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation).
- Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria): • Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease) • RF-positive polyarthritis • RF-negative polyarthritis • PsA • ERA
- Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDS) administered per local label, and/or non-steroidal anti-inflammatory drugs for ERA and PsA subtypes.
- Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the protocol.
You likely can't join if
- Subject with a body weight <15 kg.
- Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).
- Subject with undifferentiated arthritis.
- Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.
- Subject with systemic JIA.
- Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus).
See the full eligibility criteria
Who can join
- Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening evaluations.
- Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation).
- Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria): • Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease) • RF-positive polyarthritis • RF-negative polyarthritis • PsA • ERA
- Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDS) administered per local label, and/or non-steroidal anti-inflammatory drugs for ERA and PsA subtypes.
- Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the protocol.
What rules you out
- Subject with a body weight <15 kg.
- Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).
- Subject with undifferentiated arthritis.
- Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.
- Subject with systemic JIA.
- Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus).
- Subject has any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
- Subject has an active infection.
- Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.