EUCTR2009-012520-84-SI进行中（未招募）不适用
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 - CLIPPER
Wyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USA0 个研究点目标入组 100 人开始时间: 2009年8月19日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects must have met ILAR criteria for diagnosis of 1 of the
- •following JIA subtypes (see Attachment 1 for ILAR criteria) before the screening
- •visit and must be within the specified age range at the time of the screening visit:
- •- extended 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:
- •- Extended oligoarticular JIA:
- •- >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
- •range of motion accompanied by either pain or tenderness)
- •- A history of intolerance or an unsatisfactory response to at least a 3 month
- •course of at least 1 DMARD at an adequate dose.
- •- >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
- •range of motion accompanied by either pain or tenderness)
- •- A history of intolerance or an unsatisfactory response to at least a 3 month
- •course of at least 1 DMARD at an adequate dose.
- •- >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
- •range of motion accompanied by either pain or tenderness)
- •- A history of intolerance or an unsatisfactory response to at least 1 of the following:
- •- at least a 1 month course of at least 1 NSAID at an adequate dose
- •- at least a 3 month course of at least 1 DMARD at an adequate dose.
- •3. Subjects taking hydroxychloroquine, chloroquine, sulphasalazine, or MTX must
- •have been receiving these for at least 3 months before the baseline visit. Only 1
- •of these DMARDs is to be taken throughout the study and the dose must be held
- •stable for at least 8 weeks before the baseline visit.
- •4. All male and female subjects who, in the opinion of the investigator, are
- •bologically capable of having children and are sexually active, must agree and
- •commit to the use of a reliable method of birth control for the duration of the
- •study and for 30 days after the last dose of investigational product.
- •- Female subjects who, in the opinion of the investigator, are biologically capable
- •of having children must have a negative urine pregnancy test at screening and
- •baseline (day 1) before administration of investigational product.
- •5. Either the subject or an available adult must be capable (according to the
- •investigator’s judgment) of reconstituting and administering injections of SC
- •etanercept.
- •6. The parent or legally authorized representative/guardian of the subject must be
- •able to read and complete the protocol-specified efficacy assessments.
- •7. The subject and the parent or legally authorized representative/guardian of the
- •subject must be willing and able to participate in all applicable aspects of the
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or
- •undifferentiated arthritis per ILAR criteria.
- •2. Arthritis in an HLA-B27 positive male beginning after the 6th birthday (for PsA
- •and extended oligoarticular JIA subtypes only as defined per ILAR criteria).
- •3. The presence of immunoglobulin M (IgM) rheumatoid factor (RF) on at least 2
- •occasions at least 3 months apart.
- •4. Subjects with active uveitis within 6 months of the baseline visit.
- •5. Subjects with other rheumatic diseases including but not limited to Lyme disease,
- •systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or
- •reactive arthritis, overlap syndrome (eg, Sharp’s syndrome), or Reiter’s syndrome.
- •6. Subjects with pustular, or erythrodermic psoriasis.
- •7. Prior treatment with any biologic drugs, including TNF inhibitors, abatacept,
- •rituximab, and tocilizumab.
- •8. Receipt within 6 months before the baseline visit:
- •- Immunosuppressive drugs (excluding corticosteroids) (eg, cyclophosphamide,
- •cyclosporine, azathioprine).
- •- Leflunomide.
- •9. Receipt within 3 months before the baseline visit:
- •- Any investigational nonbiologic drugs or devices.
- •10. Receipt within 2 month before the baseline visit:
- •- Any live (attenuated) vaccines
- •11. Receipt within 4 weeks before the baseline visit:
- •- A combination of nonbiologic DMARDs (eg, hydroxychloroquine, chloroquine,
- •sulphasalazine, MTX).
- •- Nonbiologic DMARDs other than that which will be continued during the study
- •(ie, hydroxychloroquine, chloroquine, sulphasalazine, or MTX), or those not
- •listed under other exclusion criteria.
- •- Ultraviolet A (UVA), ultraviolet B (UVB), or psoralen + UVA (PUVA) therapy for
- •psoriatic lesions.
- •12. Receipt within 2 weeks before the baseline visit:
- •- More than 1 NSAID, or a change in the dose or type of the NSAID, or an NSAID
- •dose greater than the maximum recommended dose.
- •- More than 0.2 mg/kg/day or > 10 mg/day, whichever is less, of oral prednisone
- •or equivalent, or a change in the dose of prednisone or its equivalent. Receipt
- •of intra-articular or soft tissue corticosteroid injection or bolus intramuscular
- •(IM) or corticosteroids.
- •- Topical steroids, oral retinoids, topical vitamin A or D analog preparations or
- •anthralin for psoriatic lesions (exception – topical therapies are permitted on
- •the scalp, axillae, and groin at low to moderate strength; the dose and type
- •must be held stable for at least 2 weeks before the baseline visit).
- •13. Any major illness/condition or evidence of unstable clinical condition (eg,
- •cardiovascular [including congestive heart failure], cerebrovascular, neurologic,
- •metabolic, immunologic, infectious, hepatic, renal condition, uncontrolled
- •diabetes mellitus or hypertension), or any serious disorder (eg, current or history
- •of alcohol or drug abuse, current or history of psychiatric disease) that, in the
- •investigator’s judgment, will substantially increase the risk associated with the
- •subject’s participation in and completion of the study, or could preclude
- •the evaluation of the subject’s response, or interfere with the subject’s ability to
- •give informed consent.
- •14. Pregnant or breastfeeding female subjects.
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