EUCTR2007-005905-23-GB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 - M10-261, FINAL 30Nov07
适应症
相关药物
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
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 a 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 MTX (PO, SC or intramuscular [IM]), the doses must be stable
- •for at least 4 weeks prior to Screening blood draw and follow standard
- •recommendations for MTX treatment (ie according to the packaging insert)
- •5. If a subject is on a DMARD other than MTX, the subject must discontinue it for at
- •least 28 days before the Baseline Visit/first dose of investigational product (IP)
- •(wash-out period).
- •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 Centers for Disease Control (CDC) recommended
- •preventive therapy for TB or other local guidelines. Prophylactic treatment
- •should be captured on the concomitant medications page in the case report
- •form (CRF) and in the source documents.
- •? Subject has documented prophylactic treatment for TB and so need not repeat
- •this treatment.
- •? Active TB has been ruled out.
- •10. Subjects must be able and willing to provide written informed consent and comply
- •with the requirements of this study protocol.
- •11. Subjects must be able and willing to self-administer SC injections or have a
- •qualified person available to administer SC injections.
- 另有 5 项未显示
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/d
- •prednisone equivalent are allowed
- •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 (eg, Rituximab,
- •Tocilizumab, Abatacept, etc)
- •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 (eg, severe anemia,
- •leukopenia, thrombocytopenia), renal, liver disease (eg, fibrosis, cirrhosis,
- •hepatitis), or 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 laboratory analyses show any of the following abnormal
- •laboratory results:
- •? Aspartate transaminase (AST) or alanine transaminase (ALT) >2.0x the upper
- •limit of normal (ULN).
- •? Serum total bilirubin > 1.5 mg/d
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