Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND

ROCHE0 个研究点目标入组 1,500 人开始时间: 2009年3月20日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Male or non-pregnant, non-nursing female 2. >18 years of age 3. Diagnosis of moderate to severe RA (DAS28 >3.2) of >6 months duration 4. Receiving treatment on an outpatient basis 5. Patients on >1 non-biologic DMARDs at a stable dose for a period >8 weeks prior to treatment (day 1) 6. Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy 7. If patients are receiving an oral coricosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment (day 1) 8. 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 RA, including systemic lupus
•erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma,
•polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty?s syndrome)
•Patient with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted
•Sjögren?s Syndrome with RA is permitted
•3. Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confined to wheel chair,
•permitting little or no self-care)
•4. Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
•et al. (i.e. Drug-specific exclusion criteria)

发起方