Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST

Roche a/s0 个研究点目标入组 56 人开始时间: 2011年7月27日最近更新: 2014年6月2日

试验速览

暂无简介。

•1. Male or non-pregnant, non-nursing female
•2. = 18 years of age
•3. Receiving treatment on an outpatient basis
•4. RA of = 6 months duration
•5. Moderate to severe active RA: (DAS28 = 3.2)
•6. Patients on = 1 non-biologic DMARDs and/or TNF?-inhibitor at a stable dose for a period = 8 weeks prior to treatment
•7. Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy
•8. If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment
•9. Able and willing to give written informed consent and comply with the requirements of the study protocol
•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

•1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
•2. Rheumatic autoimmune disease other than rheumatoid arthritis
•3. Functional class IV as defined by the ACR Classification of Functional Status in
•4. Prior history of or current inflammatory joint disease other than RA
•Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
•5. Previous treatment with rituximab and abatacept
•6. Pregnant women or nursing (breastfeeding) mothers
•7. Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD
•8. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
•9. Preivious treatment with any cell-depleting therapy
•10. Preivious treatment with any tocilizumab
•11. History of or currently active primary or secondary immunodeficiency
•12. Known active current og history of recurrent infection (incliding TB)
•13. Body weight of > 150 kg

发起方

Roche a/s