ISRCTN61158084已完成不适用

Individualised therapy of rheumatoid arthritis with anti-tumour necrosis factor (TNF) antibodies (adalimuab) based on neuroendocrine biomarkers, a prospective clinical study

niversity Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)0 个研究点目标入组 60 人开始时间: 2008年9月30日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Rheumatoid arthritis (RA) is diagnosed according to the American College of Rheumatology criteria
•2. Both males and females, age must be 18 years or older
•3. Patients must have given written informed consent
•4. The disease duration should be less than 24 months
•5. The DAS28 score must be above 5.0
•6. The number of swollen joints must be >=8
•7. The number of tender joints must be >=10
•8. The erythrocyte sedimentation rate must be >=28 mm/hour

•1. Other inflammatory arthropathies such as psoriasis arthritis and similar conditions
•2. Treatment with disease modifying anti-rheumatic drugs (DMARDs), glucocorticoids, or biologics
•3. Severe or uncontrolled co?morbidities (e.g. infectious, metabolic, hepatic, cardiac, malignant, psychiatric co?morbidities)
•4. A positive screening test result for tuberculosis (purified protein of tuberculin 5 [PPD5] test, chest radiography). Patients at high risk for tuberculosis are excluded or are treated with isoniazid up to 300 mg/day concomitantly.
•5. Patients of child-bearing potential without adequate contraceptive protection
•6. Patients with contraindications for trial drugs

发起方

niversity Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)