EUCTR2012-005370-62-IT进行中（未招募）1 期
o-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study.
OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA0 个研究点目标入组 200 人开始时间: 2013年1月11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
- 200
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=18 years (for males and females; •Previous diagnosis of rheumatoid arthritis fulfilled American College of Rheumatology/EULAR criteria for RA;•diabetes mellitus type II diagnosed according to American Diabetes Association criteria with a duration of more than 6 months;•patients with an inadequate response to previous treatment with methotrexate (determined on the basis of the evaluation of the physician);•BMI<35;•glycated hemoglobin >7%<10%;•Minimum Disease Activity Score-28 (DAS 28)>3.2;•Patients previously treated with other bio, after a wash-out period of 1 months;•Patients don’t have changes in either types or doses of hypoglycaemic medications during the 3-month period preceding the study;•Patients don’t have changes in either types or doses of medications during the 1-month period preceding the study;•absence of signs and symptoms of ischemic heart disease;•Written patients consent after detailed information.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Duration of diabetes more than 10 years;•Serious chronic infection or during an acute infection which is currently active;•chronic granulomatous infections (e.g., a previous diagnosis of tuberculosis or a current diagnosis based on chest radiography or laboratory exam);•a history of recurrent infections or a predisposition to infection;•C-peptide <0.5 ng/mL (0.1665 nmol/L);•neutropenia (leukocyte count<2000/mm3) or anemia (hemoglobin level <11g/dl for men and less than 10 g/di for women;•presence of one or more contraindication of anakinra RCP;•presence of one or more contraindication of TNF ihibitor RCP; •presence of one or more contraindication to metrotrexate treatment;•previous heart attack or ischemia;•patients suffering from cardiac insufficiency: grade of NYHA severity III or IV;•Liver insufficiency/liver disease raised liver parameters (ALAT/ASAT);•Pregnancy or female patients with the ability to get pregnant, who do not use any efficacious method of contraception;•Lactation;•Participation in another clinical study util 6 month before enrollment;•Serious depression or other relevant psychiatric disease;•Serious renal injury, known malignancy;•Clinically significant history of alcohol or drug addiction may preclude the subject's participation in the study; in the judgment of the physician;•any condition that, in the opinion of the physician, precludes the possibility of using the study drug (anakinra, Kineret) or control drug (anti-TNF-alpha L04AB ATC) in accordance with the conditions of RCP;•any other condition or laboratory parameter that, in the opinion of the physician, precludes the subject's participation in the study.
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