EUCTR2013-000337-13-DE进行中（未招募）1 期
Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA)
niversitätsklinikum Erlangen0 个研究点目标入组 156 人开始时间: 2013年2月12日最近更新:
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
- 156
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
- •Understands and voluntarily signs an informed consent
- •Male or female, aged = 18 years at time of consent
- •Must be able to adhere to the study visit schedule and
- •other protocol requirements
- •Must satisfy the 2010 ACR/EULAR classification criteria
- •for rheumatoid arthritis plus a disease duration of at
- •least 6 months
- •Must have active RA with a DAS28 =3.2
- •= 3 swollen and/or tender joints of the hands
- •At screening- visit patients should have been treated
- •without alterations of therapy for at least three months
- •with DMARDS (i.e. Methotrexate) with or without
- •concomitant use of steroids).
- •Glucocorticoids treatment up to 10mg prednisolone per
- •day will be allowed at study entry.
- •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 156
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Individuals not able to understand and follow study
- •protocol and not able to voluntarily sign informed consent
- •Individuals with claustrophobia, tattoos containing metal,
- •magnetic endoprostheses, surgery on bone in between a
- •time interval < 3 months.
- •Patients treated before with any biological or small
- •molecule or medication under investigation for the
- •treatment of RA.
- •Patients with serious or chronic infections within the
- •previous 3 months
- •Opportunistic infections within the 6 months before
- •Cancer within the 5 years before screening (with the
- •exception of treated and cured squamous or basal cell
- •carcinoma of the skin)
- •History of severe congestive heart failure
- •Current signs or symptoms of severe, progressive, or
- •uncontrolled renal, hepatic, hematologic, gastrointestinal
- •(a.e.diverticulitis), endocrine, pulmonary, cardiac,
- •neurologic or cerebral disease
- •Transplanted organ (with the exception of corneal
- •transplantation done more than 3 months before
- •Evidence of active tuberculosis
研究者
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