EUCTR2004-000922-59-CZ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
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
- 675
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).
- •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, hydroxychloroquine, sulfasalzine, azathiopine 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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