EUCTR2009-013091-40-CZ进行中（未招募）不适用
Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. A parent or guardian has voluntarily signed and dated an informed consent form,
- •approved by an Institutional Review Board (IRB)/Independent Ethics Committee
- •(IEC), after the nature of the study has been explained and the subject's parent or
- •legal guardian has had the opportunity to ask questions. The informed consent
- •must be signed before any study-specific procedures are performed or before any
- •medication is discontinued for the purpose of this study.
- •2. Subject has a disease diagnosis of moderate to severe active polyarticular or
- •polyarticular course JIA (defined as arthritis affecting = 5 joints at the time of
- •treatment initiation). This corresponds to the International League of Associations
- •for Rheumatology (ILAR: Appendix C) categories of polyarticular rheumatoid
- •factor positive (RF+), and polyarticular Rheumatoid factor negative (RF-) disease.
- •3. Subject must be aged 2 to < 4 years old with moderately to severely active
- •polyarticular JIA or polyarticular course JIA or age 4 or greater weighing < 15 kg
- •with moderately to severely active polyarticular JIA or polyarticular course JIA,
- •per ILAR criteria.
- •4. Subject is judged to be in generally good health as determined by the Investigator
- •based upon the results of medical history, laboratory profile, and physical
- •examination performed at Screening and confirmed at Baseline. This includes, but
- •is not limited to, a normal cardiopulmonary and normal neurological exam result.
- •5. Parent or legal guardian must be able and willing to administer subcutaneous (SC)
- •injections or have a qualified person available to administer SC injections.
- •6. Parent or legal guardian must be willing to actively supervise storage and
- •administration of study drug and to ensure that the time of each dose is accurately
- •recorded in the subject's diary.
- •7. Subject must have negative PPD test (or equivalent) at Screening. If subject has a
- •positive PPD test result, a chest X-ray (PA and lateral view) must be performed. Ifsubject has a positive test (or equivalent), has had a post ulcerative reaction to PPD placement, and/or a chest X-ray consistent with TB exposure, subject must have
- •documented completion of course of anti-TB therapy.
- •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
排除标准
- •1. Subject has had prior exposure to Tysabri® (natalizumab) or any other biologic
- •therapy, such as Orencia® (abatacept). Any previous use of anti-TNF agents,
- •including Etanercept (Enbrel®), Infliximab (Remicade®), certolizumab pegol,
- •golimumab, and adalimumab is also prohibited.
- •2. Subject has undergone joint surgery within the preceding two months of the
- •Screening Visit (at joints to be assessed within the study).
- •3. Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
- •4. Subject has a history of an allergic reaction or significant sensitivity to constituents
- •of the study drug, adalimumab.
- •5. Subject has been treated with any investigational biologic agents (e.g., Kineret®
- •(anakinra) and Rituxan (rituximab). Should these biologics become approved,
- •they would continue to be excluded.
- •6. Subject has a poorly controlled medical condition, such as uncontrolled diabetes,
- •unstable heart disease, recent cerebrovascular accidents, seizure disorder, and any
- •other condition which, in the opinion of the Investigator, would put the subject at
- •risk by participation in the study.
- •7. Subject has a history of clinically significant hematologic (e.g., severe anemia,
- •leukopenia, thrombocytopenia, a clotting disorder), renal, liver disease
- •(e.g., fibrosis, cirrhosis, hepatitis), or active gastroenteric ulcer.
- •8. Subject is known to have any acquired immune deficiency (i.e., HIV infection) or
- •untreated congenital immunodeficiency. Abbott Study-Designated Physician
- •approval required for specific congenital immunodeficiency cases.
- •9. Subject is considered by the Investigator, for any reason, to be an
- •unsuitable candidate for the study.
- •10. Subject has evidence of active TB infection.
- •11. Subject has history of moderate to severe congestive heart failure (NYHA class III
- •or IV), recent cerebrovascular accident or thrombotic event and any other
- •condition which, in the opinion of the investigator, would put the subject at risk by
- •participation in the protocol.
- •12. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS
- •demyelinating disease.
- •13. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
- •human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
- •chronic recurring infections or active TB.
研究者
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