Phase
Condition
Joint Injuries
Rheumatoid Arthritis (Pediatric)
Arthritis And Arthritic Pain (Pediatric)
Treatment
Filgotinib
Clinical Study ID
Ages 8-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participant with a body mass index (BMI) within the 5th to 95th percentiles for theage and gender (based on World Health Organization BMI charts). Participant musthave a minimum weight of 15 kg.
Participant must meet the International League of Associations for Rheumatologyclassification for 1 of the following categories and have, according to theinvestigator's judgment, moderately to severely active disease that is notadequately controlled with his/her current therapy.
Rheumatoid factor (RF)-positive polyarthritis
RF-negative polyarthritis
Oligoarthritis
Psoriatic arthritis
Enthesis-related arthritis (ERA) Note: Historical Human leukocyte antigen B-27 (HLA-B27) results are considered appropriate for ERA diagnosis duringscreening.
Systemic JIA with active arthritis without active systemic features, or withactive systemic features that are stable in the prior 6 months of time ofenrollment
Participant with intolerance or a history of inadequate response to at least one ofthe following medications for the treatment of JIA, administered for at least 12weeks, based on current treatment guidelines: conventional syntheticdisease-modifying antirheumatic drugs and biological disease-modifying antirheumaticdrugs (including methotrexate) and non-steroidal anti-inflammatory drugs for ERA andpsoriatic arthritis.
Female participants of childbearing potential (i.e. who have passed menarche) musthave a negative highly sensitive urine pregnancy test.
Exclusion
Key Exclusion Criteria:
Participant with persistent oligoarthritis.
Participant with undifferentiated arthritis.
Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupuserythematosus, or uncontrolled uveitis).
Active infection that is clinically significant, as per judgment of theinvestigator.
Participant with a history of complicated herpes zoster infection (withmulti-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
Currently on any therapy for chronic infection (such as pneumocystis,cytomegalovirus, herpes simplex, or atypical mycobacteria).
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study Design
Connect with a study center
CHU Amiens - Hopital Nord
Amiens Cedex 1, 80054
FranceActive - Recruiting
Bicêtre University Hospital
Le Kremlin Bicêtre, 94270
FranceActive - Recruiting
Bicêtre University Hospital, Pediatric Rheumatology
Le Kremlin Bicêtre, 94270
FranceActive - Recruiting
Children's university hospital Charité, Campus Virchow, SPZ
Berlin, 13353
GermanyActive - Recruiting
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, 22081
GermanyActive - Recruiting
Malopolskie Badania Kliniczne
Krakow, 30-002
PolandActive - Recruiting
Hospital Sant Joan de Deu
Barcelona, 08950
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
United KingdomSite Not Available
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