drugset / Trial / NCT01421069
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
NaOpen-labelTreatment
Summary
This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) \[extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)\] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
Timeline
- Start
- 2011-10-10
- Primary completion
- 2021-02-04
- Completion
- 2021-02-04
Publications
- Chasnyk V, Constantin T, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Rumba-Rozenfelde I, Wulffraat N, Akikusa J, Avcin T, Burgos-Vargas R, Chaitow J, Carlini L, Tsekouras V, Graham D, Borlenghi C, Vlahos B, Zang C, Ruperto N. Predictors of inactive disease and remission in children and young adults with juvenile idiopathic arthritis treated with etanercept. Rheumatology (Oxford). 2026 May 5;65(5):keag198. doi: 10.1093/rheumatology/keag198.
- Vojinovic J, Foeldvari I, Dehoorne J, Panaviene V, Susic G, Horneff G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Akikusa J, Avcin T, Borlenghi C, Arthur E, Tatulych SY, Zang C, Tsekouras V, Vlahos B, Martini A, Ruperto N. Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Jan 4;63(1):140-148. doi: 10.1093/rheumatology/kead183.
- Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etanercept | Protein / enzyme biologic | 0.8 mg/kg | Subcutaneous |
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |