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 350 人开始时间: 2008年2月18日最近更新: 2012年8月21日

适应症

试验速览

暂无简介。

•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

•The presence of any of the following will exclude a patient from study enrolment:
•Suffering from another disease, which requires glucocorticoid treatment, e.g. asthma, neurodermatitis
•Synovectomy within 4 months prior to study start
•Use of glucocorticoids (by any route) within 6 weeks prior to screening visit (Visit 0)
•Prior use of biologicals: TNFa inhibitors within 3 months prior to screening visit (Visit 0) or other compounds within 1 year prior to screening 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.)

发起方

itec Pharma AG