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临床试验/EUCTR2005-000784-26-GB
EUCTR2005-000784-26-GB进行中（未招募）1 期

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.

Bristol Myers Squibb International Corporation0 个研究点目标入组 750 人开始时间: 2005年7月15日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
750
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

入选标准

  • •1) Subject is willing to participate in the study and has signed the informed consent.
  • •2) Males or females (not nursing and not pregnant) = 18 years of age. Males and
  • •women of child-bearing potential are eligible if they are practicing effective
  • •contraceptive measures.
  • •3) Subjects must meet the criteria of the American Rheumatism Association (1987) for
  • •the diagnosis of rheumatoid arthritis.
  • •4) Subjects must have a diagnosis of RA less than or equal to 2 years.
  • •5) Subjects must have high disease activity as defined by a tender joint count of at least 12, swollen joint count of at least 10, and a CRP of = .45 mg/dL or = 4.5 mg/L.
  • •6) Subjects that are RF or anti-CCP positive.
  • •7) Subjects must have evidence of erosion of the hands, wrists or feet on the screening radiograph. (To be read centrally)
  • •8) Subjects must be methotrexate naive or their prior exposure must have been =10mg a week for not more than 3 weeks and no dose for 3 months prior to signing the informed consent.
  • •9) Men and women (not nursing and not pregnant) = 18 years of age. Men and Women of childbearing potential are eligible if they are practicing effective contraceptive measures.
  • •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
  • •25 IU/L or equivalent units of HCG) within 48 hours prior to the start of study
  • •medication.
  • •Male subjects must be using an adequate method of contraception throughout the study including up to 10 weeks after the last infusion of abatacept so that the risk of pregnancy to their partner is minimized.
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 10 weeks after the last infusion of abatacept.
  • •2) Subjects who are impaired, incapacitated, or incapable of completing study related
  • •assessments.
  • •3) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
  • •erythematous).
  • •4) Subjects who have previously received treatment with an approved or investigational biologic RA therapy (infliximab, etanercept, anakinra, adalimumab).
  • •5) Subjects with active vasculitis of a major organ system with the exception of
  • •rheumatoid nodules.
  • •6) Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
  • •7) Female subjects, who have not had age and/or risk factor appropriate breast cancer screening or who have had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations (Please refer to Section 7.3.2).
  • •8) Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing.
  • •9) Subjects who have clinically significant drug or alcohol abuse.
  • •10) Subjects with any serious acute bacterial infection (such as pneumonia or
  • •pyelonephritis) unless treated and completely resolved with antibiotics.
  • •11) Subjects with severe chronic or recurrent bacterial infections (such as recurrent
  • •pneumonia, chronic bronchiectasis).
  • •12) The following subjects are excluded from this study:
  • •- Subjects with current clinical or laboratory evidence of active or latent
  • •tuberculosis (TB).
  • •- Subjects with a history of active TB that was treated within the last 3 years.
  • •- Subjects with a history of active TB greater than 3 years ago unless there is
  • •documentation that the prior anti-TB treatment was appropriate in duration and
  • •13) Subjects with herpes zoster that resolved less than 2 months prior to enrollment.
  • •14) Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection.
  • •15) Subjects with Hepatitis B surface antigen.
  • •16) Subjects with Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR-positive.
  • •17) Subjects with any of the following laboratory values:
  • •- Hgb < 8.5 g/dL.
  • •- WBC < 3,000/mm3 (3 x 109/L)
  • •- Platelets < 100,000/mm3 (100 x 109/L).
  • •- Serum creatinine > 2 times upper limit of normal.
  • •- Serum ALT or AST > 2 times upper

研究者

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