EUCTR2007-001114-17-GB进行中（未招募）不适用
A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).
F. Hoffmann-La Roche Limited0 个研究点目标入组 120 人开始时间: 2008年2月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able and willing to give written informed consent and comply with the
- •requirements of the study protocol
- •2. Patients with rheumatoid arthritis >6 months duration diagnosed according to the
- •revised 1987 American College of Rheumatology criteria.
- •3. Able to receive treatment on an outpatient basis
- •4. Have received MTX for at least 12 weeks immediately prior to baseline, of which
- •the last 8 weeks prior to baseline must have been at a stable dose of between 7.5
- •and 25 mg/week (oral or parenteral). Patients who have partially responded MTX,
- •but discontinued treatment for surgery or pregnancy may reinitiate treatment at least
- •8 weeks prior to baseline with a stable dose for at least 4 weeks.
- •5. All DMARDs, other than MTX will be withdrawn prior to baseline (see Inclusion
- •#7 and Exclusion #12)
- •6. Oral corticosteroids (= 10 mg/day prednisone or equivalent) and NSAIDs (up to the maximum recommended dose) are permitted if the dose has been stable for at least
- •4 weeks prior to baseline
- •7. Prior to randomization, will have discontinued etanercept for = 2 weeks, infliximab
- •or adalimumab for = 8 weeks, anakinra for = 1 week, or abatacept for = 8 weeks
- •(see exclusion #9); discontinuation of leflunomide for =12 weeks (or =4 weeks after
- •11 days of standard cholestyramine washout).
- •8. Swollen joint count (SJC) = 6 (66 joint count) and tender joint count (TJC) = 6 (68
- •joint count) at screening (Week -3) and baseline
- •9. At screening HS-CRP = 1.0 mg/dL (10 mg/L) or ESR = 28 mm/hr
- •10. Palpable carotid and femoral pulse at screening
- •11. 18 years = Age = 75 years
- •12. Must be willing to receive oral folate at a minimum dose of 5 mg/week
- •13. Females of child-bearing potential and males with female partners of child-bearing 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)
- •14. If female and of childbearing potential, the patient must have a negative urine
- •pregnancy test within three weeks prior to 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
排除标准
- •1. Major surgery (including joint surgery) within eight weeks prior to screening or
- •surgery planned to occur during the first 24 weeks of the study
- •2. Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma,
- •polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis,
- •pulmonary fibrosis or Felty’s syndrome). Sjögren’s Syndrome with RA is allowable
- •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 (e.g., gout,
- •reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme
- •5. Patients weighing >150 kg
- •6. Patients with uncontrolled co-morbidities, such as diabetes (insulin-dependent),
- •hypertension (systolic blood pressure > 150 mm Hg or diastolic blood pressure >
- •100 mm Hg), CAD or CHF, or current atrial fibrillation and cardiac conditions
- •precluding accurate evaluation of PWV and/or safety
- •7. Secondary causes of hyperlipidemia, such as uncontrolled primary hypothyroidism
- •or nephrotic syndrome
- •8. Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
- •9. Inadequate response to an anti-TNF agent during the 6 months prior to baseline
- •10. Inadequate response to more than 2 anti-TNF agents
- •11. Initiation of treatment with lipid-lowering agents within 12 weeks prior to baseline; treatment with lipid lowering agents must be at a stable dose within this period
- •12. Initiation of oral anti-diabetes or anti-hypertensive medication dose within 12
- •weeks prior to baseline; treatment with anti-hypertensive agents must be at a stable dose within this period
- •13. Treatment with any investigational agent within 6 weeks of baseline
- •14. Previous treatment with any cell depleting therapies within 6 months of baseline,
- •including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3,
- •anti-CD19, anti-CD20, and anti-BLys)
- •15. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba ™ column within 6 months of baseline
- •16. Immunization with a live/attenuated vaccine within four weeks prior to baseline
- •17. Previous treatment with TCZ
- •18. Any previous treatment with alkylating agents within 1 year of baseline such as
- •cyclophosphamide or chlorambucil, or with total lymphoid irradiation
- •19. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- •20. History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic
- •ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis or other
- •symptomatic lower GI conditions that might predispose to perforations
- •21. Evidence of serious uncontrolled concomitant cardiovascular, nervous system,
- •pulmonary (incl. obstructive pulmonary disease), renal, hepatic, endocrine (incl.
- •uncontrolled diabetes mellitus) or gastrointestinal disease
- •22. Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel
- •disease where flares are commonly treated with oral or parenteral corticosteroids
- •23. Current liver disease as determined by principal investigator.
- •24. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
- •or other infections or any major episode of infection requiring hospitalization or completion of treatment with IV antibiotics within four weeks of screening or completion of treatment with oral antibiotics within two weeks prior to screening
- •25. Primary or secondary immunodeficiency (hi
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