CTRI/2009/091/000402已完成3 期
Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 11
- 主要终点
- To assess the safety and tolerability of tocilizumab (TCZ)monotherapy or in combination with non-biologic diseasemodifyingantirheumatic drugs (DMARDs) in patients withmoderate to severe active RA
研究概览
简要总结
India is participating with the recruitment target of 50 patients. India Recruitment started on 8-May-2009 , currently ongoing.All the 11 sites have been initiated and India Completed the recruitment of 50 patients in the study in AUG 2009 and all sites were closed in India in Aug 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-nursing female
- •Greater or equal to 18 years of age
- •Diagnosis of RA of Greater or equal to 6 months duration and moderate to severe disease activity defined as a DAS28 greater 3.2 at screening
- •Receiving treatment on an outpatient basis
- •Patients on greater or equal to 1 non-biologic DMARDs and/or anti-TNF therapy (see section 6.1) at a stable dose for a period greater or equal to 8 weeks at any time prior to treatment (baseline)
- •Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy
- •If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment (baseline)
- •Able and willing to give written informed consent and comply with the requirements of the study protocol.
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following enrollment
- •Rheumatic autoimmune disease other than RA, including systemic lupuserythematosus (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 arepermittedSjögren?s Syndrome with RA is permitted
- •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)
- •Prior history of or current inflammatory joint disease other than RA (e.g. gout,reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)Drug-specific
- •Treatment with any investigational agent or with anakinra, calcineurin inhibitors (e.g.tacrolimus or cyclosporine) , mycophenolate mofetil or mycophenolic acid sodiumwithin 4 weeks (or 5 half-lives of investigational agent, whichever is longer) beforescreening
- •Previous treatment with any cell-depleting therapies, including investigational agents(e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20)
- •Previous treatment with abatacept
- •Treatment with leflunomide in combination with MTX
- •Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 6months before baseline
- •Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- •Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •Previous treatment with TCZ (an exception to this criterion may be granted forsingle-dose exposure upon application to the sponsor on a case by case basis)
- •Serum creatinine > 142 μmol/L (1.6 mg/dL) in female patients and > 168 μmol/L (1.9mg/dL) in male patients and no active renal disease.
- •ALT (SGPT) or AST (SGOT) > 1.5 ULN (If initial sample yields ALT [SGPT] orAST [SGOT] > 1.5 ULN, a second sample may be taken and tested during thescreening period)
- •Platelet count < 100 x 109/L (100,000/mm3)
- •WBC count < 1.0 x 109/L (1000/mm3), ANC < 1 x 109/L (1000/mm3)
- •ALC < 0.5 x 109/L (500/mm3)
- •Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody
- •Total bilirubin > ULN (If initial sample yields bilirubin > ULN, a second sample maybe taken and tested during the screening period)
- •Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted)General medical
- •Pregnant women or nursing (breastfeeding) mothers
- •Females of child-bearing potential who are not using a reliable means ofcontraception, e.g. physical barrier (patient and partner), contraceptive pill or patch,spermicide and barrier, or IUD
- •History of severe allergic or anaphylactic reactions to human, humanized, or murinemonoclonal antibodies
- •CXR evidence of any clinically significant abnormality
- •Evidence of serious uncontrolled concomitant cardiovascular, nervous system,pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine(including uncontrolled diabetes mellitus) or GI disease
- •In patients with a history of diverticulitis or diverticulosis requiring antibiotictreatment, the treating physician needs to consider the benefit-risk ratio
- •A history of chronic ulcerative lower GI disease such as Crohn?s disease, ulcerativecolitis or other symptomatic lower GI conditions that might predispose to perforations
- •Current liver disease as determined by principal investigator.
- •Patients with priorhistory of ALT (SGPT) elevation are not excluded
- •Known active current or history of recurrent bacterial, viral, fungal, mycobacterial orother infections (including but not limited to tuberculosis and atypical mycobacterialdisease, clinically significant abnormalities on CXR as determined by the investigator,hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds), orany major episode of infection requiring hospitalization or treatment with IVantibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior toscreening (does not apply to treatment of latent TB)
- •History of or currently active primary or secondary immunodeficiency
- •Evidence of active malignant disease, malignancies diagnosed within the previous 5years (including hematological malignancies and solid tumors, except non-melanomaskin cancer that has been excised and cured), or breast cancer diagnosed within theprevious 5 years
- •Active tuberculosis (TB) requiring treatment within the previous 3 years
- •Patients should be screened for latent TB, prior to biologics use, as per localguidelines or good clinical practice in your country.
- •Patients with latent tuberculosisshould be treated with standard antimycobacterial therapy (at least 4 weeks) beforeinitiating TCZ and have a negative CXR for active TB at screening.
- •HIV positive patient
- •History of alcohol, drug or chemical abuse within the 6 months prior to screening
- •Neuropathies or other painful conditions that might interfere with pain evaluation
- •Patients with lack of peripheral venous access
- •Body weight of > 150 kg.
结局指标
主要结局
To assess the safety and tolerability of tocilizumab (TCZ)monotherapy or in combination with non-biologic diseasemodifyingantirheumatic drugs (DMARDs) in patients withmoderate to severe active RA
时间窗: Incidence of adverse events and serious adverse eventsduring 24 weeks of TCZ monotherapy or combinedtreatment with TCZ and one or more of the background nonbiologicdisease modifying anti-rheumatic drugs (DMARDs)approved for rheumatoid arthritis (RA) in patients withmoderate to severe active RA
次要结局
未报告次要终点
研究者
研究点 (11)
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