Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA

niversity Medical Center Utrecht0 个研究点目标入组 120 人开始时间: 2019年7月22日最近更新: 2023年12月12日

适应症

试验速览

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••Able and willing to give written informed consent.
•Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol.
•At least 18 years of age.
•Diagnosed as having RA and meeting the 2010 ACR/EULAR criteria for RA (Appendix A).
•Active RA defined by CDAI>10 and at least 1 swollen joint of the 28 joint count.
•For patients < 65 years of age: On stable treatment with csDMARDs for = 8 weeks prior to the screening visit.
•Eligible to start with a biological according to the 2019 EULAR guidelines for management of RA (see appendix L): previous treatment with =2 csDMARDs OR previous treatment with =1 csDMARD with presence of a prognostically unfavorable factor.
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 20

•Having a contraindication for treatment with systemic GCs (as determined by the treating rheumatologist, in line with regular care).
•Having a contraindication for treatment with TCZ, as determined by the treating rheumatologist or as described in the Summary of Product Characteristics (SPC) Paragraph 4.3, page 33. ‘Special warnings and precautions for use’ as described in the SPC Paragraph 4.4, page 33, should be strictly followed.
•Use of systemic GCs (including i.a. GCs) within 4 weeks before the screening visit.
•Current use of a bDMARD or tsDMARD; i.e. these need to be discontinued before start of study medication. Wash out periods for bDMARDs and tsDMARDs should follow routine care.
•Treatment with any investigational agent within 4 weeks prior to the screening visit.
•Having any other inflammatory rheumatic disease than RA., except for secondary Sjögren’s syndrome will be allowed, as well as RA-overlap syndromes that are primarily treated as RA at the time of screening.
•Female who is pregnant (by anamnesis) or breast feeding, or considering becoming pregnant during the study period.

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