EUCTR2005-000181-39-AT进行中（未招募）1 期
A Prospective Trial of Anti-TNF-a Chimeric Monoclonal Antibody (infliximab, Remicade®) on Insulin Sensitivity, Beta Cell Function and Cardiovascular Risk Profile in Insulin Resistant Human Obesity
Med. Universitaetsklinik Graz, ao Univ. Professor Dr. med. Thomas C. Wascher0 个研究点目标入组 18 人开始时间: 2005年7月27日最近更新:
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
- 18
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
- Male
入选标准
- •Subjects to be included must meet the following criteria:
- •1. Men between 20 and 50 years of age.
- •2. BMI between and including 30 and 35 kg/m2
- •3. HOMA index > 2.5
- •4. History of stable weight (+/- 2 kg) > 3 months
- •5. Blood pressure > 135 / 85 mmHg (or treated hypertension)
- •6. Triglycerides > 1.7 mmol/l or HDL-cholesterol < 1.3 mmol/l
- •7. Men or their partner must use adequate birth control measures (eg, abstinence,
- •oral contraceptives, intrauterine device, barrier method with spermicide, or
- •surgical sterilization) for the duration of the study and should continue such
- •precautions for 6 months after receiving the last infusion.
- •8. The screening laboratory test results must meet the following criteria:
- •a. Hemoglobin>= 8.5 g/dL
- •b. WBC>= 3.5 x 10 hoch 9/L
- •c. Neutrophils>= 1.5 x 10 hoch 9/L
- •d. Platelets>= 100 x 10 hoch 9/L
- •e. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper
- •limit of normal range for the laboratory conducting the test.
- •9. Subject must be able to adhere to the study visit schedule and other protocol
- •requirements.
- •10. The subject must be capable of giving informed consent and the consent must
- •be obtained prior to any screening procedures.
- •11. Must have a chest radiograph within 3 months prior to first infusion with no
- •evidence of malignancy, infection or fibrosis.
- •12. Are considered eligible according to the following tuberculosis (TB) screening
- •a. Have no history of latent or active TB prior to screening.
- •b. Have no signs or symptoms suggestive of active TB upon medical history
- •and/or physical examination.
- •c. 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 agent.
- •d. Within 1 month prior to the first administration of study agent, either have a
- •negative tuberculin skin test, as outlined in Appendix B, or have a newly
- •identified positive tuberculin skin test during screening in which active TB has
- •been ruled out and for which appropriate treatment for latent TB has been
- •initiated either prior to or simultaneously with the first administration of study
- •e. Have a chest radiograph (both posterior-anterior and lateral views), taken
- •within 3 months prior to the first administration of study agent and read by a
- •qualified radiologist, with no evidence of current active TB or old inactive TB.
- •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
- •Subjects will be excluded from this study for any of the following reasons:
- •1. Patients with overt diabetes (fasting glucose > 7.0 mmol/l).
- •2. Current treatment with angiotensin II antagonists or ACE inhibitors.
- •3. Treatment indication with statins according to the current NCEP III criteria.
- •4. Treatment indication with low dose acetylsalicylic acid according to the current
- •AHA quidelines or any other NSAID.
- •5. Current smokers.
- •6. Patients with (a history of) an autoimmune disease.
- •7. Use of any investigational drug within 1 month prior to screening or within 5 half-
- •lives of the investigational agent, whichever is longer.
- •8. Treatment with any other therapeutic agent targeted at reducing TNFa (eg,
- •pentoxifylline, thalidomide, etanercept, adalimumab) within 3 months of screening.
- •9. Previous administration of infliximab.
- •10. History of receiving human/murine recombinant products or known allergy to
- •murine products.
- •11. Serious infections (such as 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.
- •12. Documented HIV infection.
- •13. Active hepatitis- B or antibodies against hepatitis-C
- •14. Have a history of latent or active granulomatous infection, including TB,
- •histoplasmosis, or coccidioidomycosis, prior to screening.
- •15. Have or have had a opportunistic infection (eg, herpes zoster [shingles],
- •cytomegalovirus, Pneumocystis carinii, aspergillosis,) within 6 months prior to
- •16. Have current signs or symptoms of severe, progressive or uncontrolled renal,
- •hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
- •or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- •17. Concomitant congestive heart failure, including medically controlled
- •asymptomatic patients.
- •18. Presence of a transplanted organ (with the exception of a corneal transplant > 3
- •months prior to screening).
- •19. 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).
- •20. History of lymphoproliferative disease including lymphoma, or sign 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.
- •21. Known recent substance abuse (drug or alcohol).
- •22. Poor tolerability of venipuncture or lack of adequate venous access for required
- •blood sampling during the study period.
- •23. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of
- •24. Have a chest radiograph within 3 months prior to randomization that shows an
- •abnormality suggestive of a malignancy or current active infection, including TB.
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