EUCTR2005-005367-28-BE进行中（未招募）1 期
A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-type Psoriasis - RESTORE II
Schering-Plough Research Institute, a division of Schering Corporation0 个研究点目标入组 500 人开始时间: 2006年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
入选标准
- •The subject must meet ALL of the criteria listed below for entry:
- •1. Subjects must have met all inclusion/exclusion criteria in Study P04271.
- •2. Subjects must have been originally randomized to infliximab in Study P04271.
- •3. Subjects must have completed the full 26 weeks of Study P04271.
- •4. Subjects must have remained on infliximab for the full 22 weeks of treatment
- •in Study P04271.
- •5. Subjects must have achieved an improvement in Psoriasis Area and Severity
- •Index (PASI) score =75% from Baseline of Study P04271 to Week 26 of
- •Study P04271.
- •6. Subjects must agree to avoid prolonged sun exposure and avoid use of
- •tanning booths or other ultraviolet light sources during the study.
- •7. Subjects are considered eligible according to the following tuberculosis (TB)
- •a. Have no signs or symptoms suggestive of active TB upon medical
- •history and/or physical examination;
- •b. Have had no recent close contact with a person with active TB or, if
- •there has been such contact, will be referred to a physician
- •specializing in TB to undergo additional evaluation and, if warranted,
- •receive appropriate treatment for latent TB prior to or simultaneously
- •with the first administration of study medication.
- •8. Subjects’ Baseline (Visit 1) clinical laboratory tests (CBC, blood chemistry,
- •and urinalysis) must be within the following parameters:
- •a. Hemoglobin =10 g/dL
- •b. White blood cells =3.5 x 10 9/L
- •c. Neutrophils =1.5 x 10 9/L
- •d. Platelets =100 x 10 9/L
- •e. Serum creatinine <1.5 mg/dL (or <133 µmol/L)
- •f. Aspartate aminotransferase, alanine aminotransferase, alkaline
- •phosphatase, and gamma-glutamyltransferase levels as outlined in
- •g. Total bilirubin < 2 x upper limit of normal
- •9. Subjects must be free of any clinically significant disease (other than plaque-type
- •psoriasis or psoriatic arthritis) that would interfere with the study
- •evaluations.
- •10. Subjects must be willing to give written informed consent and be able to
- •adhere to dose and visit schedules.
- •11. Women of childbearing potential and all men must be using adequate birth
- •control measures (eg, abstinence, oral contraceptives, intrauterine device,
- •barrier method with spermicide, or surgical sterilization) and must continue
- •using such measures until 6 months after receiving the last infusion of study
- •medication.
- •12. Female subjects of childbearing potential must have a negative urine
- •pregnancy test at Baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The subject will be excluded from entry if ANY of the criteria listed below are
- •1. Subjects who have any significant ongoing AEs or AEs from P04271 that
- •would prohibit further treatment with infliximab at the time of entry.
- •2. Subjects originally randomized to methotrexate or subjects who received
- •methotrexate at any time during their participation in Study P04271.
- •3. Subjects who have non-plaque forms of psoriasis (eg, erythrodermic, guttate,
- •or pustular).
- •4. Subjects who have current drug-induced psoriasis (eg, a new onset of
- •psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel
- •blockers, or lithium).
- •5. Female subjects who are pregnant, nursing, and both men and women who
- •are planning pregnancy during the study period or during the 6 months after
- •receiving of the last infusion of study medication.
- •6. Subjects who are in a situation or have any condition that, in the opinion of
- •the investigator, may interfere with optimal participation in the study.
- •7. Subjects who are staff personnel directly involved with this study.
- •8. Subjects who are family members of the investigational study staff.
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