EUCTR2007-003508-36-GB进行中（未招募）1 期
A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2
itec Pharma AG0 个研究点目标入组 0 人开始时间: 2008年2月29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
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
入选标准
- •Provide written informed consent
- •Have a documented history of RA (sero-negative or sero-positive) in agreement with the ACR criteria including the symptoms morning stiffness, joint pain, tender and swollen joints, inflammatory state with elevated erythrocyte sedimentation rate (ESR) or C reactive protein (CRP)
- •Be on disease modifying anti-rheumatic drugs (DMARD) treatment for RA for at least 6 months, with a stable dose for at least 6 weeks prior to screening visit (Visit 0)
- •Have duration of morning stiffness of at least 45 minutes
- •Have swollen joint count of 4 or more out of 28
- •Have tender joint count of 4 or more out of 28
- •Aged 18 to 80 years
- •Female patients of childbearing potential must be using a medically accepted contraceptive regimen
- •Able to perform the required study procedures including handling of medication containers and diaries
- •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
- •The presence of any of the following will exclude a patient from study enrolment:
- •Suffering from another disease, which requires glucocorticoid treatment during the study period, e.g. asthma, neurodermatitis
- •Synovectomy within 4 months prior to study start
- •Use of glucocorticoids:
- •- Continued use of systemic glucocorticoids within 4 weeks prior to screening visit (Visit 0)
- •- Intermittent use of glucocorticoids within 2 weeks prior to screening visit (Visit 0). (Intermittent is defined as a maximum of 7 days treatment with a cumulative dose of < or equal to 100mg prednisone or equivalent within 6 weeks prior to Visit 0)
- •- Joint injections within 6 weeks prior to screening visit (Visit 0)
- •- Topical glucocorticoids, e.g. intra-nasal or inhaled glucocorticoids must be stopped at screening visit (Visit 0)
- •Use of biologicals such as: tumour necrosis factor a (TNFa) inhibitors and other compounds within 5 serum half lives prior to screening visit (Visit 0)
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- •Pregnancy or nursing
- •Participation in another clinical study (use of an investigational product) within 30 days preceding visit (Visit 0)
- •Re-entry of patients previously enrolled in this trial
- •Suspected inability or unwillingness to comply with study procedures
- •Alcohol or drug abuse
- •Requirement of nonpermitted concomitant medication
- •Known hypersensitivity to prednisone or predniso(lo)ne
- •Any contraindication for low dose prednisone treatment
- •Significant renal impairment (serum creatinine > 150 µmol/L)
- •Significant hepatic impairment (investigator’s opinion)
- •Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
研究者
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