A 2-PART OPEN-LABEL STUDY TO ASSESS THE CLINICAL BENEFIT AND LONG-TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS

Not Applicable

Suspended

• Registration Number: PER-012-10
• Lead Sponsor: ABORATORIOS WYETH S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 0

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).
oA 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).
oA 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).
oA 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

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified