EUCTR2009-017938-46-IT进行中（未招募）不适用
A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis. - ND
适应症
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
- 45
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. Ages = 6 to < 18 years at Baseline. 2. Diagnosis of Enthesitis Related Arthritis (ERA) as defined by the International League of Associations for Rheumatology (ILAR) prior to subject`s sixteenth birthday. 3. Subjects must have disease activity as defined by the fulfilment of the following conditions: • At least 2 active joints (swelling not due to deformity or joints with limitation of motion plus pain and/or tenderness) AND • Evidence of enthesitis in at least two locations 4. Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug (NSAID) and at least one DMARD, either sulfasalazine (SSZ) or methotrexate (MTX). Patients who have a contraindication to SSZ and MTX use may be enrolled in the study. 5. Subject must have an updated immunization schedule according to the Canadian Immunization Guide in Canada, the Mexican Immunization Guide in Mexico, or the Local European Guideline. 6. If female, subjects who are sexually active and are of childbearing potential should be practicing an approved method of birth control throughout the study and for 150 days after study completion. Examples of approved methods of birth control include the following: • Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD); • Oral, parenteral or intravaginal contraceptives for 90 days prior to study drug administration; • A vasectomized partner. 7. Parent or legal guardian, as required, has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, after the nature of the study has been explained and the subject`s parent or legal guardian has had the opportunity to ask questions. Subjects will be included in all discussions in order to obtain verbal/and or written assent. 8. 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. 9. Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and 12-lead electrocardiogram (ECG) performed during Screening. 10. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at Screening. If subject has a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement, and/or a CXR consistent with prior TB exposure, subject must initiate and complete a minimum of 2 weeks of anti-TB therapy or have documented completion of a course of anti-TB therapy prior to Baseline. 11. Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.
- •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. Subjects fulfilling a diagnosis of any ILAR JIA subtype other than ERA. 2. Psoriasis or a history of psoriasis in the patient or first-degree relative. 3. Presence of IgM rheumatoid factor on at least two occasions at least 3 months apart. 4. Presence of systemic JIA. 5. History of inflammatory bowel disease. 6. Previous biologic therapy including anti-TNF therapy with a potential impact on pediatric ERA. 7. Diagnosis of acute inflammatory joint disease not associated with ERA. 8. Known hypersensitivity to adalimumab or its excipients. 9. Subject has received intra-articular joint injection(s) with corticosteroids within 28 days prior to Baseline. 10. Joint surgery within 2 months prior to Baseline. 11. If entering the study on concomitant MTX or SSZ at Screening/Baseline, subject not on stable dose of MTX (= 15 mg/m2 with a maximum of 25 mg/ week) or SSZ (= 50 mg/kg/day with a maximum of 2 g/day) for 28 days prior to Baseline. 12. Subject on concomitant DMARDs other than MTX or SSZ 28 days prior to Baseline. 13. If entering the study on concomitant prednisone (and/or prednisone equivalents), subjects not on a stable dose (= 10 mg/day or 0.2 mg/kg body weight whichever is lower) for 14 days prior to Baseline. 14. If entering the study on concomitant NSAIDs and/or analgesics, subject on opioid analgesics within 14 days prior to Baseline or subject not on stable dose for 14 days prior to Baseline. 15. Subject who has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Baseline. 16. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline. 17. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB. 18. History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol. 19. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. 20. History of clinically significant drug or alcohol abuse in the last 12 months. 21. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease. 22. Positive pregnancy test at Screening or Baseline. 23. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study. 24. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 25. Subject has received any live or live/attenuated vaccines within 90 days prior to screening. 26. Subject with diagnosis and current symptoms of fibromyalgia. 27. Screening laboratory and other analyses show any of the following abnormal results: • ECG – with clinically significant abnormalities; • Aspartate transaminases (AST) or alanine transaminase (ALT) > 1.75 ? the upper limit of the reference range; • Total bilirubin = 3 mg/dL; • Serum creatinine > 1.6 mg/dL.
研究者
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