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

MC Utrecht0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年6月11日

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. • On stable treatment with csDMARDs for = 8 weeks prior to the screening visit. • Previous treatment with =2 csDMARDs OR previous treatment with =1 csDMARD in combination with a maximum of 1 TNF inhibitor (Wash out period: =2 weeks before first administration of study medication).

•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. • Previous use of = 2 TNF-inhibitors. • Previous use of any other bDMARD (beside 1 TNFi) or tsDMARD. • 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. • Female who is pregnant (by anamnesis) or breast feeding, or considering becoming pregnant during the study period.

发起方

MC Utrecht