Biomarkers identification of anti-TNF a agent’s efficacy in Ankylosing Spondylitis patients using a transcriptome analysis and mass spectrometry

Faculdade de Ciências Médicas da Universidade Nova de Lisboa0 个研究点目标入组 70 人开始时间: 2014年2月21日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•AS according to SPR guidelines (1984 modified New York Criteria, but allowing the use of MRI as imagiological criteria)
•Patient enrolment followed national guidelines for TNF antagonist use for the treatment of AS
•Adults between 18 to 75 years
•Ability to provide informed consent
•Corticosteroid therapy allowed (equivalent to = 10 mg prednisone) and / or NSAID, dose stable in 4 weeks before study iniciation
•Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners
•Adequate renal and hepatic function (2 times ULN)
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Current pregnancy or breastfeeding
•Any persistent or severe infection within 30 days of baseline
•Previous treatment with biologic DMARD's
•Intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints = 28 days before screening
•History of rheumatic disorder other than AS
•Other forms of spondylarthritis than AS
•Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease)
•History or signs of demyelinating disease
•Active or latent tuberculosis (TB) or histoplasmosis
•Malignancy (except for completely treated squamous or basal cell carcinoma)
•Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus
•Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment
•Ankylosis of the spine (sindesmophytes presence at all levels from D12 to S1 in XR lateral view)

发起方

Faculdade de Ciências Médicas da Universidade Nova de Lisboa