EUCTR2018-004539-54-DE进行中（未招募）1 期
Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte
Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP0 个研究点目标入组 192 人开始时间: 2019年4月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
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
- •Patients with active RA and an inadequate response to up to two previous csDMARD treatments (MTX, LEF, SSZ) with or without ongoing csDMARD therapy
- •RA according to ACR classification criteria
- •Age 18 – 65 years
- •Active RA is defined as
- •oDAS28 > 3.2 and
- •oTJC = 3 and SJC ? 3
- •VAS-pain = 60mm (0-100 mm)
- •Accompanying CS treatment for RA with a stable dosage of = 2mg/d and ? 10 mg/d 2 weeks prior to BL (not more than 30% of patients without CS)
- •Accompanying need of NSAID or analgesic treatment due to arthritis and in dosages not exceeding the maximum dose according to SmPC
- •If ongoing csDMARD treatment, stable treatment will be defined as either
- •oMTX treatment with a dosage of ? 10 mg/week and < 25 mg/week, continuously for at least 12 weeks prior to Screening (SCR) with a stable dose of MTX for at least 2 weeks prior to BL or
- •oLEF treatment with a dosage between 10 to 20 mg/day, continuously for at least 12 weeks prior to SCR with a stable dose of LEF for at least 2 weeks prior to BL or
- •oSSZ treatment with dosage between 1 to 3 g/day, continuously for at least 12 weeks prior to SCR with a stable dose of SSZ for at least 2 weeks prior to BL
- •Presence of documented negative results for testing of Hepatitis B and C
- •Completed SARS-CoV-2-immunisation as currently recommended by the Standing Committee of Vaccination
- •Written informed consent obtained prior to the initiation of any protocol-required procedures
- •Willingness to comply to study procedures and study protocol
- •Inclusion criteria related to csDMARD treatment:
- •For those patients without csDMARD treatment (MTX, LEF, SSZ) at study inclusion the following must be fulfilled:
- •MTX-treatment must be terminated for at least 12 weeks prior to BL
- •LEF must be terminated for at least 24 weeks prior to BL or its elimination will be forced as usual in daily clinical practice using Cholestyramin or activated carbon (according to SmPC of LEF)
- •SSZ must be terminated for at least 12 weeks prior to BL
- •For those patients with ongoing csDMARD treatment (MTX, LEF, SSZ) at study inclusion the following must be fulfilled:
- •oMTX, LEF or SSZ treatment continuously for at least 12 weeks prior to the Screening visit (with stable dose of MTX for at least 2 weeks prior to BL visit)
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Previous use of Tofacitinib or other JAK-inhibitors
- •Previous use of Etanercept
- •Previous use of any biological agent for RA
- •owhich was stopped due to lack of efficacy
- •oone previous use of biological stopped due to intolerance will be allowed
- •CS treatment with dosages >10 mg at BL
- •Known hypersensitivity to any component of the study medication (TOFA, ETA, Celecoxib)
- •Previous use of Celecoxib as analgesic therapy which was stopped due to lack of efficacy or intolerance
- •Concomitant diseases with chronic pain syndrome or need of extended dosages or long-term treatment with the maximum dosages of NSAID/analgesics (according to SmPc) due to other concomitant diseases/pain symptoms in the discretion of the treating physician
- •Exclusion criteria related to general health
- •Patients with other chronic inflammatory articular disease or systemic autoimmune disease
- •Patients with active Tb (Evaluation according to local standards in clinical routine care)
- •Patients with latent Tb, that are not pre-treated for at least 1 month and planned to be treated 9 months in total with Isozid once a day
- •Any active infection, a history of recurrent clinically significant infections (e.g. HIV) or a history of recurrent bacterial infections with encapsulated organisms
- •Primary or secondary immunodeficiency
- •Current malignancy or history of malignancies except adequately treated or excised basal cell or squamous cell carcinoma or cervical carcinoma in situ.
- •Patients of 50 years and older, if they have one or more cardiovascular risk factors (CVRF) defined as:
- •oCurrent cigarette smoking or patients who used to smoke for a long time (long time” will be defined by the treating physician),
- •oKnown diagnosis of hypertension,
- •oHDL <40 mg/dl,
- •oDiabetes mellitus,
- •oHistory of coronary artery disease: history of revascularization procedure, coronary artery bypass grafting, myocardial infarction, cardiac arrest, unstable angina, acute coronary syndrome or
- •oHistory of premature coronary heart disease or sudden death documented in first degree relatives (male relative before 55 years, female relative before 65 years)
- •Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient’s safety and with the study outcome
- •History of a severe psychological illness or condition
- •Known hypersensitivity to sulfonamides
- •Active peptic ulceration or gastrointestinal (GI) bleeding
- •Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs including COX-2 Inhibitors
- •Risk for or history of thrombotic events (e.g. pulmonary embolism or thrombosis)
- •Severe hepatic dysfunction (serum albumin < 25 g/L or Child-Pugh score = 10)
- •Patients with estimated creatinine clearance < 30 mL/min
- •Inflammatory bowel disease
- •Congestive heart failure (NYHA II-IV)
- •Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- •Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
- •Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier)
- •Alcohol, drug or chemical abuse
- •Exclusion criteria related to prior treatments
- •Current participation in another interventional clinical trial or
研究者
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