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临床试验/EUCTR2004-000922-59-SE
EUCTR2004-000922-59-SE进行中（未招募）不适用

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).

Bristol Myers Squibb International Corporation0 个研究点目标入组 660 人开始时间: 2004年10月13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
660
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

  • •* Subject is willing to participate in the study and signed the informed consent.
  • •* Subjects must meet the criteria of the American Rheumatism Association (1987) for
  • •the diagnosis of rheumatoid arthritis and the American College of Rheumatology
  • •(1991) functional Classes I, II, or III. (Refer to protocol appendices 1 and 2.)
  • •* Subjects must have been taking methotrexate for at least 3 months at a weekly dose of at least 15 mg, and at a stable dose for 28 days prior to treatment (Day 1)
  • •* Men and women, ages 18 = 75 years old. Men and Women of childbearing potential are eligible if they are practicing effective contraceptive measures.
  • •* Methotrexate alone: Subjects who are treated only with methotrexate will not require washout.
  • •* Methotrexate plus other DMARDs: Subjects who are treated with methotrexate in
  • •combination with another anti-rheumatic treatment (DMARD) will require washout
  • •of the other DMARD.
  • •* Drug stabilization requirements (except methotrexate)
  • •a) All DMARDs (except methotrexate) should be discontinued at least 28 days prior
  • •to treatment (Day 1).
  • •i) In the case of leflunomide, the subject can be washed out with cholestyramine
  • •according to manufacturer recommendations.
  • •b) Oral corticosteroid treatment must have been reduced to the equivalent of 10 mg
  • •prednisone daily for 28 days and stabilized for at least 25 out of 28 days prior to
  • •treatment (Day 1).
  • •For Subjects Receiving Methotrexate Alone:
  • •At randomization (Day 1), subjects must have the following disease activity:
  • •a) 10 or more swollen joints (66 joint count) and
  • •b) 12 or more tender joints (68 joint count) and
  • •c) C-reactive protein (CRP) = 1 mg/dL (Result used from screening visit)
  • •For Subjects Receiving Other DMARDs Plus Methotrexate:
  • •At screening visit, subjects must have the following disease activity:
  • •a) 6 or more swollen joints (66 joint count) and
  • •b) 8 or more tender joints (68 joint count) and
  • •c) No restriction on CRP
  • •IN ADDITION
  • •All subjects who are receiving other DMARDs plus methotrexate therapy at the screening visit must undergo a 28 day washout period of their other anti-rheumatic treatment (DMARD) (other than methotrexate).
  • •After washout at randomization (Day 1), subjects must have the following disease
  • •a) 10 or more swollen joints (66 joint count) and
  • •b) 12 or more tender joints (68 joint count) and
  • •c) C reactive protein (CRP) = 1 mg/dL. (Result used from Day -3 visit).
  • •Long-Term Extension (Protocol Amendment 03)
  • •Subjects must be willing to participate in the long term extension and sign consent. Subjects who enter the long term extension must continue to meet Inclusion/ Exclusion criteria as outlined in Protocol IM101043 and/or all subsequent amendments, with the exception of tender and swollen joint counts, CRP, dose of methotrexate, PPD skin testing, and male contraception use requirement.
  • •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

  • •* 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
  • •* Any previous or current medical conditions that are contraindications to the use of
  • •TNF blocking agents. (Please refer to Appendix 11 and 12 Remicade Labels)
  • •* Subjects who have previously received treatment with an approved biologic RA
  • •therapy (Infliximab, Etanercept, Anakinra, Adalimumab).
  • •* Subjects who have failed more than 4 DMARDs (including methotrexate) due to lack
  • •of efficacy (DMARDs approved for the treatment of RA include methotrexate,hydroxycholoroquine, sulfasalzine, leflunomide, azathioprine, and gold).
  • •* Subjects with active vasculitis of a major organ system (except for subcutaneous
  • •rheumatoid nodules).
  • •* Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
  • •hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
  • •* 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
  • •* 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.
  • •* Subjects with active tuberculosis (TB) requiring treatment within the previous
  • •3 years. Subjects with a positive PPD at screening will not be eligible for the study
  • •unless active TB infection has been ruled out, they have initiated treatment for latent
  • •TB for at least 4 weeks prior to dosing of study drug, and they have a negative chest
  • •x-ray at enrollment.
  • •* Hepatitis B surface antigen-positive subjects.
  • •* Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR-positive.
  • •* 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 limit of normal.

研究者

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