EUCTR2005-004530-40-AT进行中（未招募）不适用
Induction of remission in RA patients at low disease activity by additional Infliximab-therapy
AESCA Pharma Ges.m.b.H0 个研究点目标入组 160 人开始时间: 2005年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •Age: > 35 years and < 65 years.
- •Diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year
- •(max. 10 years) prior to start of therapy.
- •Patients have active disease: DAS 28 between 2,8 and 3,5
- •Changes in DAS 28 score <0.6 during the last 6 weeks before inclusion.
- •RA basic therapy must be stable and according to standard criteria for at least 3 months.
- •The screening laboratory test results must meet the following criteria:
- •Hemoglobin > 10.0 g/dL, WBC> 3.5 x 109/L;Neutrophils > 1.5 x 109/L
- •Platelets> 100 x 109/L ,SGOT (AST), SGPT (ALT) and alkaline phosphatase, total bilirubin and serum creatinine levels must be within < 2 times the UNL
- •Prothrombin time INR < 1.5
- •Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should be willing to continue such precautions for 6 months after receiving the last infusion.
- •Patient must have at least 1 swollen joint.
- •Patient must have evidence of erosive disease by x-ray 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion).
- •Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- •History of any other therapeutic agent targeted at reducing TNF
- •History of previous administration of Infliximab.
- •History of receiving human/murine recombinant products or known allergy to murine products.
- •Serious infections (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
- •Have active TB or have evidence of latent TB
- •HBs antigen positive, HCV antibody positive, documented HIV infection
- •Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobac-terium infection, etc, within the previous 6 months.
- •Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, psychiatric, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- •Concomitant congestive heart failure = NYHA II
- •Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
- •Fibromyalgia
- •Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
- •Known recent substance abuse (drug or alcohol).
研究者
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