Actively Recruiting
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
Led by Alfasigma S.p.A. · Updated on 2025-12-10
10
Participants Needed
10
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
CONDITIONS
Official Title
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant aged 8 to less than 18 years
- Body mass index (BMI) within the 5th to 95th percentile for age and gender
- Minimum body weight of 15 kg
- Diagnosed with juvenile idiopathic arthritis according to International League of Associations for Rheumatology criteria, including categories like rheumatoid factor-positive or negative polyarthritis, oligoarthritis, psoriatic arthritis, enthesis-related arthritis, or systemic JIA with stable systemic features
- Moderately to severely active disease not adequately controlled by current therapy
- History of intolerance or inadequate response to at least one JIA medication such as methotrexate or biological disease-modifying antirheumatic drugs for at least 12 weeks
- Female participants of childbearing potential must have a negative pregnancy test
You will not qualify if you...
- Persistent oligoarthritis
- Undifferentiated arthritis
- Other rheumatic, inflammatory, or immunologic diseases such as inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis
- Clinically significant active infection
- History of complicated herpes zoster infection involving multiple areas or central nervous system
- Currently receiving therapy for chronic infections like pneumocystis, cytomegalovirus, herpes simplex, or atypical mycobacteria
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
CHU Amiens - Hopital Nord
Amiens, France, 80054
Actively Recruiting
2
Bicêtre University Hospital
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
3
Children's university hospital Charité, Campus Virchow, SPZ
Berlin, Germany, 13353
Actively Recruiting
4
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, Germany, 22081
Actively Recruiting
5
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany, 53757
Not Yet Recruiting
6
Malopolskie Badania Kliniczne
Krakow, Poland, 30-002
Actively Recruiting
7
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
8
Hospital Sant Joan de Deu
Barcelona, Spain, 08950
Actively Recruiting
9
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
10
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Not Yet Recruiting
Research Team
P
Pilar de la Torre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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