EUCTR2007-004241-15-DE进行中（未招募）不适用
A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-ControlledStudy to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. Revised Protocol 01 incorporating Protocol Amendment 03 (v2.0, dated 16-Oct-2008). And Pharmacogenetics Blood sample Amendment - Site Specific
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
- 220
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) Signed Written Informed Consent
- •2) Target Population
- •a) meet Classification Criteria for Psoriatic Arthritis (CASPAR) (Appendix 3)
- •for a duration of disease at least 3 months
- •b) prior failure of DMARD therapy (inefficacy or intolerance); if patient had
- •prior failure of methotrexate, s/he must have been on at least 15 mg/week dose
- •for at least 2 months
- •c) if recent failure of a TNFa blockade compound (inefficacy or intolerance),
- •must be washed out prior to first dose: 56 days for infliximab and 28 days for
- •etanercept and adalimumab
- •d) disease activity as defined by a tender joint count of = 3, swollen joint count
- •of = 3 and clinically detectable synovitis at screening and Day 01 (prior to
- •e) have active psoriasis with a qualifying target lesion = 2 cm in diameter
- •f) Must be able to have MRI performed.
- •3) Age and Sex
- •a) Men and women (not nursing and not pregnant) = 18 years of age at the time
- •of informed consent.
- •b) Women of childbearing potential (WOCBP) must be using an adequate
- •method of contraception to avoid pregnancy throughout the study and for up
- •to 10 weeks after the last dose of investigational product in such a manner that
- •the risk of pregnancy is minimized.
- •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
- •1. Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 10 weeks after the last
- •dose of investigational product
- •b) Women who are pregnant or breastfeeding, or plan to become pregnant, or to
- •start breastfeeding during the duration of the study
- •c) Women with a positive pregnancy test on enrollment or prior to
- •investigational product administration.
- •2) Medical History and Concurrent Diseases
- •a) Subjects who are scheduled for or anticipate joint replacement surgery.
- •b) Subjects who have a recent history of clinically significant drug or alcohol
- •c) Concomitant illness that in the opinion of the Investigator, is likely to require
- •systemic glucocorticosteroid therapy during the study (e.g.; moderate to
- •severe asthma)
- •d) Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
- •hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral
- •disease. Concomitant medical conditions that in the opinion of the
- •Investigator might place the subject at unacceptable risk for participation in
- •e) Subjects who are unwilling or unable to have screening performed based on
- •current local or country guidelines/standards to evaluate the presence of
- •cancer (e.g. breast, cervical, colon, prostate, hepatocellular, gastric).
- •f) Subjects with a history or current evidence of malignancies; specifically,
- •subjects with:
- •a history of cancer within the last five years (other than non-melanoma
- •skin cell cancers cured by local resection), or
- •evidence of current malignancy or signs of possible malignancy
- •detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded.
- •Female subjects who have had a manual examination or breast cancer
- •imaging (mammogram, ultrasound, other method) screening study that
- •is suspicious for malignancy, and in whom the possibility of
- •malignancy cannot be reasonably excluded following additional
- •clinical, laboratory, or other diagnostic evaluations (see Section 6.3.4).
- •g) Subjects at risk for tuberculosis (TB).
- •h) Subjects with any serious bacterial infection within the last 3 months, not
- •treated and resolved with antibiotics, or any chronic bacterial infection (such
- •as, but not limited to, chronic pyelonephritis, osteomyelitis and
- •bronchiectasis)
- •i) Subjects with evidence (as assessed by the Investigator) of active or latent
- •bacterial or viral infections at the time of potential enrollment, including
- •subjects with evidence of Human Immunodeficiency Virus (HIV).
- •j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than
- •2 months prior to signing informed consent
- •k) Subject who have received any live vaccines within 3 months of the
- •anticipated first dose of study medication or who will have need of a live
- •vaccine at any time, during and for 3 months after the duration of the study.
- •3) Physical and Laboratory Test Findings
- •a) Subjects with Hepatitis B surface antigen.
- •b) Subjects with Hepatitis C antibody-positive subjects who are also RIBApositive
- •or PCR positive.
- •c) Subjects with any of the following laboratory values:
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研究者
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