None listed
Conditions
Interventions
This is a phase 3b, single-treatment, open-label, 2-part multicenter study of etanercept in children and adolescents with extended oligoarticular JIA, ERA, or PsA. Part 1 is primarily designed to asse
to a maximum dose of 50 mg QW) throughout the course of their participation in this study (0881ª1-3338-WW) unless withdrawal of treatment is warranted.
Approximately 100 subjects will be enrolled a
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects must have met ILAR criteria for diagnostic of 1 of the following JIA subtypes (see Attachment 1 for ILAR criteria) before the screning visit: • Extended oligoarticular oligoarticular JIA between the ages of 2 and 17 years. • ERA between the ages of 12 and 17 years. • PsA between the ages of 12 and 17 years. 2. At both the screening and baseline visits, the following criteria must be met for the relevant JIA subtype: • Extend oligoarticular JIA: o ≥ 2 active jpints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) (see attachment 2). o A history of intolerance or an unsatisfactory response to at least a 3 month course of at least 1 DMARD at an adequate dose. • PsA: o ≥ 2 active jpints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) (see attachment 2). o A history of intolerance or an unsatisfactory response to at least a 3 month course of at least 1 DMARD at an adequate dose. • ERA: o ≥ 2 active jpints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) (see attachment 2). o A history of intolerance or an unsatisfactory response to at least 1 of the following:  At least a 1 month course of a least 1 non- steroidal anti-inflammatory drug (NSAID) at an adequate dose.  At least a 3 month course of at least 1 DMARD at an adequate dose.
Exclusion criteria
Exclusion criteria: •1. Subjects with systemic JIA, persistent Oligoarticular JIA, poly articular JIA, or undifferentiated arthritis per ILAR cruteria. 2. Subjects positive for HLA-B27 (PsA and extended oligoarticular JIA subtypes only) or immunoglobolin M (IgM) rheumatoid factor (RF) at the screening visit. 3. Subjects with active uveitis within 6 months of the baseline visit. 4. Subjects with other rheumatic diseases including but not limited to Lyme disease, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or reactive arthritis, overlap sindrome (eg, Sharp’s sindrome), or Reiter’s sindrome. 5. Subjects with guttate, pustular, or erythrodermic psoriasis. 6. Prior treatment with any biologic drugs, including TNF inhibitors, abatacepr, rituximab and tocilizumab. 7. Receipt within 6 months before the baseline visit: • Immunosuppressive drugs (excluding Corticosteroids) (eg, cyclophosphamide). • Leflunomide. 8. Receipt within 3 months before the baseline visit: • Nonbiologic DMARDs other than hydroxychloroquine, sulphasalazine, MTX, or those not listed under other exclusion criteria. • Any investigational nonbiologic drugs or devices. • Any live (attenuated) vaccines. 9. Receipt within 4 weeks before the baseline visit: • Ultraviolet A (UVA), ultraviolet B (UVB), or psoralen + UVA (PUVA) therapy for psoriatic lesions.
Contacts
Public ContactJudith Marlene Verastegui
LABORATORIOS WYETH S.A.
Outcome results
None listed