EUCTR2009-013316-12-NL进行中（未招募）不适用
A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Male or non-pregnant, non-nursing female
- •2. = 18 years of age
- •3. Early RA (disease symptoms <1 year) according to the revised 1987 ACR and/or ACR/EULAR classification criteria of 2010 for RA
- •4. Disease activity measured by DAS28 = 2,6
- •5. Patients able and willing to give written informed consent and comply with the requirements of the study protocol
- •6. Immunization status current for pneumovax, influenza as assessed according to standard of care for RA patients receiving a biological agent
- •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.Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis. Patients with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted. Sjögren’s Syndrome with RA is permitted
- •2.Current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •3. Glucocorticoids used for RA < 6 weeks prior to baseline (NB: inhaled glucocorticoids are allowed)
- •4.Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •5.Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- •6.Previous treatment with any biologic drug that is used in the treatment of RA
- •7.Previous treatment with any DMARD that is used in the treatment of RA
- •8.Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
- •9.Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 6 months before baseline
- •10.Serum creatinine > 142 µmol/L in female patients and > 168 µmol/L in male patients or an active renal disease
- •11.ALT or AST > 1.5 x ULN (if initial sample yields ALT or AST > 1.5 x ULN, a second sample may be taken and tested during the screening period)
- •12.Platelet count < 100 x 109/L (100,000/mm3)
- •13.Hemoglobin < 1.5 mmol/l below LLN for gender
- •14.WBC < 4.0 x 109/L (4000/mm3),
- •15. Absolute neutrophil count < 1.0 x 109/L (1000? 500/mm3)
- •16.Absolute lymphocyte count < 0.5 x 109/L (500/mm3)
- •17.Positive HBsAg or HCV antibody
- •18.Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (fasted)
- •19.Pregnant women or nursing (breastfeeding) mothers
- •20.Females of child-bearing potential who are not using reliable means of contraception (such as physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device)
- •21.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- •22.Chest X-ray (CXR) at screening showing evidence of any clinically significant abnormality
- •23.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
- •24.In patients with a history of complicated diverticulitis, the treating physician needs to consider the benefit-risk ratio
- •25.A known history of chronic ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforations
- •26. Active TB requiring treatment within the previous 3 years. Patients with a positive purified protein derivative tuberculin skin test (PPD) at screening as per local guidelines are not eligible for the study unless they complete treatment for latent TB and have a negative CXR at enrollment. Patients treated for tuberculosis with no recurrence in 3 years are permitted
- •27.Known uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral glucocorticoids
- •28.Current liver disease as determined by investigator. Patients with prior history of ALT elevation are not excluded
- •29. Known active current or history of recurrent bacterial, viral,
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