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

• Conditions: Extended oligoarticular juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Psoriatic arthritis (PsA); MedDRA version: 9.1Level: LLTClassification code 10003246Term: Arthritis

• Registration Number: EUCTR2009-012520-84-HU
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-06
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male and female subjects must have met ILAR criteria for diagnosis of 1 of the following JIA subtypes 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 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.
- PsA:
- >= 2 active 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.
- ERA:
- >= 2 active 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
OR
- at least a 3 month course of at least 1 DMARD at an adequate dose.
3. Subjects taking hydroxychloroquine, sulphasalazine, or methotrexate must have been receiving these for at least 3 months before the baseline visit. Only 1 DMARD 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 biologically capable of having children, 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Exclusion Criteria

1. Subjects with systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.
2. Subjects positive for HLA-B27 (PsA and extended oligoarticular JIA subtypes only) or 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 syndrome (eg, Sharp’s syndrome), or Reiter’s syndrome.
5. Subjects with guttate, pustular, or erythrodermic psoriasis.
6. Prior treatment with any biologic drugs, including TNF inhibitors, abatacept, 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
10. 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 intraarticular or soft tissue corticosteroid injection or bolus intramuscular (IM) or intravenous (IV) treatment with 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).
11. 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.
12. Pregnant or breastfeeding female subjects
13. Cancer or history of cancer.
14. History of blood dyscrasias.
15. History of Macrophage Activating Syndrome (MAS).
16. History of demyelinating diseases (eg, multiple sclerosis or optic neuritis).
17. Documented immunodeficiency disease, including subjects with known human immunodeficiency virus (HIV) at the time of the screening visit.
18. Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and/or hepatitis C virus (HCV).
19. History of drug-induced liver injury, liver cirrhosis or fibrosis at any time before the baseline visit.
20. Any of the following laboratory abnormalities at screening:
- Hemoglobin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified