EUCTR2013-000337-13-PT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) - PreCePRA
niversitätsklinikum Erlangen0 个研究点目标入组 156 人开始时间: 2015年11月11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
- •Subjects must have a diagnosis of Rheumatoid Arthritis (RA), fulfilling the new ACR/EULAR classification criteria 2010 with disease duration for at least 24 weeks.
- •Active RA with a DAS28 of >3.2
- •=3 swollen and/or tender joints of the hands
- •Subjects must be DMARD-IR (inadequate responder)
- •Must understand and voluntarily sign an informed consent form including written consent for data protection
- •Must be able to adhere to the study visit schedule and other protocol requirements
- •Must be aged = 18 years at time of consent
- •Glucocorticoids treatment up to 10 mg prednisolon per day will be allowed at study entry
- •At screening-visit patients should have been treated without alterations of DMARD therapy (for at least three months) (i.e. Methotrexate) (with or without concomitant use of steroids).
- •Must be RF and/or ACPA positive
- •= 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 not willing to follow study protocol and sign informed consent
- •Individuals treated with biological or investigational products before.
- •Individuals with claustrophobia, tattoos containing metal, magnetic endoprotheses, surgery on bone in between a time interval < 3 months, patients in any condition not allowing for MRI scan.
- •Current treatment with MMF or preparations still in development.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Any other autoimmune or inflammatory disease such as Psoriasis, SLE, PSS, MCTD, SpA, Behcet disease, vasculitis, autoimmune hepatitis or fibromyalgia
- •Participation in another phase 1-4 treatment study for RA
- •Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent
- •Pregnant or lactating female (Women with child bearing potential have to use a highly effective contraceptive measure (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs) and continue its use for the time of exposure to the drug as required). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable
- •Patients who possibly are dependent on the Principal Investigator or investigator
- •Patients with serious or chronic infections within the previous 3 months
- •Opportunistic infections within the 6 months before screening
- •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 screening)
- •Evidence of active tuberculosis
- •Evidence of chronic or active hepatitis B or C
研究者
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