A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis

Roche Oy0 个研究点目标入组 160 人开始时间: 2010年7月2日最近更新: 2013年5月13日

适应症

试验速览

暂无简介。

•To be eligible for this trial, patients must meet all of the following inclusion criteria:
•1. Able and willing to give written informed consent and comply with the requirements of the study protocol.
•2. Patients with early RA of = 2 year disease duration (defined from the onset of symptoms) at the time of the baseline visit.
•3. Patients who have received DMARDs (including MTX) = 3 months £ 7 months.
•4. Receiving treatment on an outpatient basis
•5. No previous biologic agent
•6. DAS28 > 3.2 at screening and baseline visits
•7. Swollen joint count (SJC) ³ 6 (66 joint count), and tender joint count (TJC) ³ 6 (68 joint count) both at screening and baseline visits.
•8. Age ³ 18 years
•9. Oral corticosteroids (£ 10 mg/day prednisone or equivalent) allowed.
•10. Females of child-bearing potential and non sterilized males with female partners of childbearing potential may participate in this trial only if using a reliable means of
•contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch,
•spermicide and barrier, or IUD).
•11. If female and of childbearing potential, the patient must have a negative serum pregnancy stick test at baseline.
•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 eight weeks prior to screening or planned major surgery within six months after baseline.
•2. Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma, and polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis,
•pulmonary fibrosis or Felty’s syndrome). Secondary Sjögrens syndrome or nodulosis with RA is permitted.
•3. Functional class III and IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
•4. Prior history of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease).

发起方