EUCTR2011-005260-20-GB进行中（未招募）1 期
Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 427
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
入选标准
- •1.Male or non-pregnant, non-nursing female.
- •2.= 18 years of age.
- •3.Patients currently experiencing active severe RA (DAS28 >5.1) according to the EULAR/ACR criteria for the diagnosis of RA at start of treatment (week 0).
- •4.Patients should have inadequately responded to a trial of 2 DMARDs, including MTX (as defined by NICE) and have not been previously treated with a biologic agent, such as a TNF inhibitor. NICE define a trial of DMARDs (including MTX) as being normally of 6 months, with 2 months at standard dose.
- •5.Patients with a history of parenteral (subcutaneous or intramuscular) MTX prior to start of treatment (week 0) are eligible. However, prior to treatment (day 1) these patients must have been on a stable dose of oral MTX of at least 10 mg/week.
- •6.If patients are receiving an oral corticosteroid, the dose must have been = 10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to start of treatment (day 1).
- •7.Patients receiving treatment on an outpatient basis.
- •8.Patients 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) no
- •F.1.2.1 Number of subjects for this age range 513
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1.Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomisation
- •2.Rheumatic autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and Sjögren’s Syndrome with RA are permitted.
- •3.Functional class IV as defined by ACR Classification of Functional Status in RA
- •4.Prior history of/current inflammatory joint disease other than RA
- •Drug-specific
- •5.Treatment with leflunomide, or cholestyramine washout within 3 months prior to enrolment.
- •6.Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- •7.Previous treatment with RoActemra
- •8.Previous treatment with any biologic drug that is used in the treatment of RA
- •9.Any previous treatment with alkylating agents eg as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
- •10.Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6 months before enrolment
- •11.Intra-articular/parenteral corticosteroids within 6 weeks prior to enrolment
- •12.Immunisation with a live/attenuated vaccine within 4 weeks prior to enrolment
- •Laboratory analyses (at screening)
- •13.Serum creatinine > 142 µmol/L (1.6 mg/dL) in female patients and > 168 µmol/L (1.9 mg/dL) in male patients
- •14.ALT (SGPT) or AST (SGOT)> 2 x ULN
- •15.Platelets< 100 x 109/L (100,000/mm3)
- •16. Haemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
- •17.White blood cells< 1.0 x 109/L (1000/mm3), ANC< 1.0 x 109/L (1000/mm3)
- •18. Absolute lymphocyte count< 0.5 x 109/L (500/mm3)
- •19.Positive hepatitis B virus surface antibody (HBsAg) or Hepatitis C virus (HCV) antibody
- •20.Total bilirubin> ULN
- •21.Triglycerides> 10 mmol/L (>900 mg/dL) at screening (non-fasting or fasting)
- •General medical
- •22.Pregnant women or breastfeeding mothers
- •23.Females of child-bearing potential not using reliable means of contraception
- •24.History of severe allergic/anaphylactic reactions to human, humanised, or murine monoclonal antibodies
- •25.Chest X-Ray (CXR) evidence of any clinically significant abnormality
- •26.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (incl obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
- •27.In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician needs to consider the benefit-risk ratio
- •28. 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
- •29.Uncontrolled disease states, eg asthma, psoriasis, or inflammatory bowel disease, where flares are commonly treated with oral/parenteral corticosteroids
- •30.Current liver disease as determined by investigator. Patients with prior history of ALT (SGPT) elevation are not exc
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