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临床试验/EUCTR2007-005905-23-DE
EUCTR2007-005905-23-DE进行中（未招募）不适用

A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Abbott GmbH & Co. KG0 个研究点目标入组 424 人开始时间: 2008年1月29日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
424
研究概览入排标准研究者记录与标识符相似试验

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

  • •A subject will be eligible for study participation if he/she meets the following criteria:
  • •1. Subject is > 18 years of age.
  • •2. Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has disease duration for a minimum of three months.
  • •3. Subject must meet the following two criteria:
  • •a. At least 6 swollen joints out of 66 assessed.
  • •b. At least 6 tender joints out of 68 assessed
  • •4. If a subject is on a DMARD other than Leflunomide and MTX, the subject must
  • •discontinue the DMARD for at least 28 days before the Baseline Visit/first dose of
  • •investigational product (IP) (wash-out period). If a subject is on Leflunomide, the patient must have a wash out period of 3 months prior to Baseline, however the subject may be treated with cholestyramine to shorten this period. If a subject is on MTX, further criterion is explained below.
  • •5. MTX treatment:
  • •a. With MTX: The subject should be on a stable dose of MTX between 15 mg
  • •and 25 mg and route of administration must be maintained (PO,
  • •subcutaneous [SC] or intramuscular [IM]), for at least 6 weeks prior to
  • •Baseline blood draw. Subjects should be treated with MTX per standard recommendations (i.e. according to the packaging insert). Subjects residing
  • •in Germany must be on MTX in order to participate in this trial.
  • •b. Without MTX or Previously on MTX: The subjects may be MTX naïve
  • •from Baseline blood draw or may have been previously been treated with
  • •MTX. If the subject was previously treated with MTX, the MTX dose must
  • •have been withdrawn at least 28 days prior to Baseline blood draw.
  • •6. Female subjects either not of childbearing potential, defined as postmenopausal (at least 1 year since last menses) or surgically sterile (bilateral tubal ligation, bilateral
  • •oophorectomy or hysterectomy), or are of childbearing potential and practicing
  • •one of the following methods of birth control throughout the study and for
  • •150 days after study completion:
  • •? Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
  • •? Contraceptives (oral, parenteral, patch) for three months prior to study drug
  • •administration)
  • •? A vasectomized partner
  • •7. Female subjects of childbearing potential must have a negative serum pregnancy
  • •test at the Screening visit and a negative urine pregnancy test at Baseline/first IP
  • •8. Subject is judged to be in good general health as determined by the Principal
  • •Investigator or designee based upon the results of medical history, laboratory
  • •profile, physical examination, CXR, and 12-lead electrocardiogram (ECG)
  • •performed at Screening.
  • •9. Subjects will be evaluated for latent TB infection with a purified protein derivative
  • •(PPD) test and CXR. For this protocol, evidence of latent TB infection is defined
  • •as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement.
  • •Subjects who demonstrate evidence of latent TB infection, irrespective of Bacille
  • •Calmette - Guérin (BCG) vaccination status, and negative CXR findings for active
  • •TB and/or suspicious CXR findings will be allowed to participate in the study
  • •provided that one of the following conditions are satisfied;
  • •? Prophylactic treatment is initiated before administration of study drug. In general it is recommended, but not mandated, to start 2 weeks before study drug administration, however the course of prophylaxis need not be completed prior to the onset of study drug.
  • •Prophylactic treatment will be according to the United States CDC recommended
  • •preventive therapy for TB or othe

排除标准

  • •Subjects presenting with any of the following will not be included in the study.
  • •1. Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab,
  • •etanercept, certolizumab pegol or golimumab) including adalimumab.
  • •2. Subject has been treated with intra-articular or parenteral administration of
  • •corticosteroids in the preceding 4 weeks from Baseline visit/first IP dose. Inhaled
  • •corticosteroids for stable medical conditions are allowed. Oral of = 10 mg/day
  • •prednisone equivalent are allowed, however should be stable 3 weeks prior to Baseline and there should be no plan to dose adjust the steroids throughout the study
  • •3. Subject has undergone joint surgery within the preceding two months of Screening
  • •Visit (at joints to be assessed within the study).
  • •4. Subject has a history of acute inflammatory joint disease of different origin other
  • •than RA (eg, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age
  • •5. Subject has a history of an allergic reaction or significant sensitivity to constituents
  • •of study drugs (adalimumab, MTX, or matching placebo).
  • •6. Subject has been treated with any investigational drug of a chemical nature
  • •within one month prior to Baseline/1st IP dose.
  • •7. Subject has been treated with any investigational biologic agents (e.g., Rituximab,
  • •Tocilizumab, Abatacept, etc). Should these biologics become approved, they would be
  • •8. Subject has a poorly controlled medical condition, such as uncontrolled diabetes,
  • •unstable heart disease, congestive heart failure, recent cerebrovascular accidents
  • •and any other condition which, in the opinion of the Investigator, would put the
  • •subject at risk by participation in the study.
  • •9. Subject has a history of clinically significant hematologic (e.g., severe anemia,
  • •leukopenia, thrombocytopenia), renal, liver disease (e.g., fibrosis, cirrhosis, hepatitis), or active gastroenteric ulcer.
  • •10. Subject has history of neurologic symptoms suggestive of central nervous system
  • •(CNS) demyelinating disease and/or diagnosis of central demyelinating disease.
  • •11. Subject has history of cancer or lymphoproliferative disease other than a
  • •successfully treated non-metastatic cutaneous squamous cell or basal cell
  • •carcinoma and/or localized carcinoma in situ of the cervix.
  • •12. Subject has a history of listeriosis, histoplasmosis, active TB, persistent chronic
  • •infections, or recent active infections requiring hospitalization or treatment with
  • •intravenous (IV) anti-infectives within 30 days or oral anti-infectives within
  • •14 days prior to the Baseline visit/first IP dose.
  • •13. Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
  • •14. Subject is known to have any acquired immune deficiency (ie, HIV infection) or
  • •untreated congenital immunodeficiency. Abbott Study Designated Physician
  • •approval required for specific congenital immunodeficiency cases.
  • •15. Female subject who is pregnant or breast-feeding or considering becoming
  • •pregnant during the study or for 150 days after the last dose of study medication.
  • •16. Subject has a history of clinically significant drug or alcohol usage in the last year
  • •or cannot maintain an alcohol intake of 30 g a day or less throughout the study.
  • •One standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine,
  • •360 mL/12 oz (approx. 15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of
  • •17. Screening clinical l

研究者

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