Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA (CATARA)
研究概览
详细说明
The primary objective of this study is to evaluate the efficacy of apremilast when used in combination with a background DMARD and TNF inhibition in patients with active RA using the ACR responder index looking for a 20% improvement.
To evaluate the safety and tolerability of apremilast when used in combination with TNF inhibition in patients with active RA.
To evaluate the clinical outcomes in RA using the individual domains of the ACR responder index1 .
To evaluate the clinical outcomes of RA using the Disease Activity Score (DAS28)2 To investigate the effects of apremilast on change in cytokine plasma concentration levels (from baseline to Week 12) and the achievement of an ACR response
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form
- 18 years of age at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements
- Must have a diagnosis of RA of at least 6 months duration based on the ACR criteria
- Must have evidence of active disease with DAS-28 > 3.8
May be on one of the following DMARDs for at least 12 weeks and at a stable dose for at least 6 weeks:
- Methotrexate 7.5-25mg/week
- Hydroxychloroquine (200-400mg/day)
Must be on one of the following SQ TNF inhibitors at a stable, label approved dose for at least 12 weeks:
- adalimumab (Humira®, Abbott Laboratories, North Chicago, IL)
- certolizumab pegol (Cimzia®, UCB, Inc, Smyrna, GA)
- golimumab (Simponi®, Johnson & Johnson, New Brunswick, NJ)
- etanercept (Enbrel®, Amgen, Thousand Oaks, CA and Wyeth Pharmaceuticals, Philadelphia, PA)
- Concommitant use of non-steroidal anti-inflammatory drugs and/or oral corticosteroids (prednisone<10mg/day or equivalent) are permitted if doses have been stable for at least 14 days.
- If taking methotrexate, patient must also be taking folic or folinic acid at at dose of no less then 5mg/week.
Must meet the following laboratory criteria:
- Hemoglobin > 9 g/dL
- White blood cell (WBC) count; 3000 /;L (3.0 X 109/L) and 14,000/L (< 14 X 109/L)
- Platelets; 100,000 /L (100 X 109/L)
- Serum creatinine; 1.5 mg/dL (or 133mol/L)
- Total bilirubin; 2.0 mg/dL
- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]); 1.5x upper limit of normal (ULN)
- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner while on study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication and for one month after taking the last dose of study medication.
- Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 28 days after taking the last dose of study medication
Exclusion Criteria:
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant or breastfeeding
- Systemic fungal infection
- Active tuberculosis or a history of incompletely treated tuberculosis
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
- Clinically significant abnormality on the chest x-ray (CXR) with anteriorposterior and lateral views at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
- Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- Any clinically significant abnormality on 12-lead ECG at screening
- History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
- Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
- History of Human Immunodeficiency Virus (HIV) infection
- Antibodies to Hepatitis C at screening
- History of malignancy within 5 years prior to the screening visit (except for treated [i.e. cured] basal cell skin carcinomas and treated [i.e. cured] carcinoma in situ of the cervix)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:placebo
Patient randomized to one of two arms, either placebo, or Apremilast
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安慰剂出价
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有源比较器:Apremilast
Patients randomized to either placebo or apremilast
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Apremilast 30mg BID
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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20% improvement based on ACR responder criteria
大体时间:12 weeks
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12 weeks
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次要结果测量
结果测量 |
大体时间 |
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ACR 50/70 and DAS
大体时间:12 weeks
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12 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的