EUCTR2006-003142-42-DE进行中（未招募）不适用
A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 4SC AG
- 入组人数
- 120
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
- •6.2Subject Inclusion Criteria
- •Subjects meeting all of the following inclusion criteria will be considered for admission to the trial:
- •1.Regarding demographic data:
- •Age:From 18 years
- •Gender:Males and females
- •Race:Caucasian
- •BMI:19 - 30 kg/m2
- •2.Regarding RA:
- •Patients with early active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA
- •DAS28(CRP) = 4.1
- •(DAS28 formula with 4 variables using CRP)
- •3.Regarding previous medication for RA:
- •DMARD-naive patients or DMARD-treated patients if the required wash-out periods are respected (refer to Subject Exclusion Criteria)
- •Patients with stable oral corticosteroid therapy (dose ? 10 mg/day prednisolon equivalent)
- •4.Regarding general requirements
- •Patients having sufficient intelligence to understand the nature of the study and are willing and able to communicate with the investigator and comply with all study requirements
- •Patients willing to give informed consent in writing at enrolment into the study
- •Males willing to use condoms or to be sexually abstinent in order to protect their female partners against potential contamination with the study medication via sperm fluid
- •Females of childbearing potential willing to utilize two safe and independent methods of contraception one month before, throughout the course of the study and one month after termination of the study.
- •This must be a combination of the following:
- •1)a highly effective method of first choice = a method with a low failure rate (i.e. less than 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some IUDs (Intra Uterine Device), vasectomised partner
- •together with
- •2)a method of second choice like condom, diapharagm or cup pessary.
- •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
- •6.3Subject Exclusion Criteria
- •Subjects presenting any of the following exclusion criteria cannot be admitted to the trial:
- •1.Regarding RA:
- •Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA
- •2.Regarding pre-treatment of RA and concomitant medication:
- •History of treatment with one of the following drugs:
- •Leflunomide
- •Oral or injectable gold
- •Cyclophosphamide
- •Biologicals
- •(Abatacept, Etanercept, Adalimumab, Infliximab, Rituximab, Anakinra,)
- •Receipt of the following drugs within 4 weeks prior to dosing:
- •Methotrexate
- •Sulfasalazine
- •Hydroxychloroquine
- •Azathioprine
- •Cyclosporine
- •Receipt of parenteral or intraarticular corticosteroids
- •Use of corticosteroids > 10 mg/day
- •3.Regarding treatment of RA:
- •Non-pharmacological treatment (physical therapy)
- •4. Regarding concomitant diseases:
- •Significant cardiac arrhythmia, bradycardia or tachycardia
- •Any other significant finding in the ECG
- •Congestive heart failure
- •Uncontrolled arterial hypertension
- •Haemoglobin < 8.5 mg/l
- •White blood cell count < 3500/mm3
- •Platelet count < 125 000/mm3
- •Uncontrolled asthma
- •History of HIV, Hepatitis B or C
- •Liver enzyme levels outside the laboratory’s upper normal limit
- •Serum creatinine level > 1.4 mg/dl
- •Glomerular filtration rate < 50 ml / min / 1,73 m²
- •(Estimated GRF according to Cockroft-Gault, calculation see page 74)
- •Renal disease
- •History of or existence of urolithiasis
- •Haematuria (? 10 Ery/field on dipsticks)
- •Exception: Females during menstruation
- •In this case a second examination after the end of menstruation will be performed.
- •Psychiatric illness
- •Active tuberculosis
- •Known or suspected immunodeficiency
- •History of malignancy within the past 5 years (excl. basal cell carcinoma of the skin)
- •Inadequate contraception, pregnancy, lactation
- •History of serious drug sensitivity
- •History of alcohol dependence
- •History of drug dependence
- •5.Regarding not permitted circumstances:
- •Subject is a heavy smoker (more than 20 cigarettes per day)
- 另有 4 项未显示
研究者
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