Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment

Roche Slovensko s.r.o.0 个研究点开始时间: 2009年3月17日最近更新: 2016年4月18日

适应症

试验速览

暂无简介。

•1.Patients able and willing to sign Inform Consent Form
•2.Patients with moderate to severe active rheumatoid arthritis (according to ACR diagnostic criteria)
•3.Inadequate response , or intolerance to previous therapy with one or more traditional DMARDs
•4.DAS > 3,6
•5.Age =18
•6.Pneumology examination including chest x-ray, Quantiferon test and approval of pneumologist to initiation of biologic treatment
•7.Approval of Committee for treatment of resistant form RA in National Institute of Rheumatic Diseases
•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

•8.Known hypersensitivity to the drug substance or to any of the drug excipients.
•9.< 18 years of age
•10.Pregnancy or lactation
•11.Active infection
•12.Active tuberculosis
•13.HBsAg, HCV or HIV positivity
•14.History of serious allergic or anaphylactic reactions to human or humanized murine monoclonal antibodies
•15.History of intestinal ulceration or diverticulitis
•16.Active hepatic impairment with ALT or AST > UNL
•17.Thrombocytes < 100 000/ mm3, Leucocytes < 3000 mm/3, absolute neutrophil count< 2000 mm/3,
•18.Uncontrolled hyperlipoproteinemia
•19.Demyelinating disorders
•20.Serious cardiovascular disorders
•21.Female in fertile age with partners who do not accept usage of contraceptives
•22.Concomitant antiTNF drugs

发起方

Roche Slovensko s.r.o.