EUCTR2005-002460-29-BE进行中（未招募）1 期
An Open Extension, Investigator Initiated Trial, to Examine Radiographic progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC
Rheumazentrum Ruhrgebiet.0 个研究点目标入组 130 人开始时间: 2006年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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
- •Patients to be included must meet the following criteria:
- •1)All patients in Europe who have completed visit week 96” of EASIC
- •2)Have the capacity to understand and sign an informed consent form, are capable of reading and understanding subject assesment forms, and are willing and able to adhere to the study visit schedule and other protocol requirements.
- •3)Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
- •4)The screening laboratory test results must meet the following criteria:
- •a)Hemoglobin for males ³ 9.0 g/dL (5.6 mmol/L) and females ³ 8.5 g/dL (5.3 mmol/L)
- •b)Serum transaminase levels must be within 3 times the upper limit of normal range for the laboratory.
- •c)Serum creatinine = 1.4 mg/dL (123.8 µmol/L).
- •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
- •Patients will be excluded from this study for any of the following reasons:
- •1) General medical exclusion criteria
- •a)Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).
- •b)Documentation of seropositive for human immunodeficiency virus (HIV).
- •c)Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
- •d)Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.
- •e)Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
- •f)Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, coccidioidomycosis or mycobacteria other than TB) within 6 months prior to screening.
- •g)Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
- •h)Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
- •i)Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- •j)Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
- •k)Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- •l)Presence of a transplanted solid organ (excluding a corneal transplant)
- •m)Have a concomitant diagnosis or history of congestive heart failure.
- •n)Have a history of latent or active TB prior to screening.
- •o)Have signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- •p)Have had a recent close contact with a person with active TB. If there has been such contact, a patient 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 agent.
- •q)Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening.
研究者
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