EUCTR2006-003768-67-SE进行中（未招募）不适用
A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.
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
- 58
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
- •1) Signed written informed consent
- •2) Subjects must meet the criteria of the American Rheumatism Association (1987)
- •for the diagnosis of rheumatoid arthritis (Protocol Appendix 1).
- •3) Subjects must have a diagnosis of RA greater than 6 months and no longer than 5
- •years from the time of initial diagnosis of RA.
- •4) Subjects must have a disease activity as defined by a DAS28-CRP > 3.2 or a
- •tender joint count of = 6, a swollen joint count of = 6, and a CRP measurement
- •greater than the upper limit of normal
- •5) Subjects must have clinically detectable synovitis (i.e. synovial swelling”) of at
- •least one wrist at screening and baseline visit (D1, prior to infusion).
- •6) Subjects must have at least one erosion present in the hands/wrists and /or feet
- •(documented by previous plain radiography) or be anti-CCP positive or be
- •rheumatoid factor (RF) positive.
- •7) Subjects must have been treated with MTX, on a weekly dose of at least 15 mg or
- •a maximum tolerated dose (i.e. 10 mg weekly) for at least 3 months before
- •screening. In addition, the dose of MTX must be stable for at least 28 days prior
- •to the first study dose (baseline i.e. Day 1).
- •8) Subjects must be biologic DMARDs naive (i.e. anti-TNFa, anakinra, rituximab or
- •other investigational biologics).
- •9) Subjects who consented to have a knee/ankle arthroscopy with tissue and synovial biopsy must have clinically detectable synovitis (i.e. synovial swelling”) of at
- •least one knee/ankle at screening and baseline visit (D1).
- •10) At randomization (Day 1), subjects must have the following disease activity :
- •a) 6 or more swollen joints (66 joint count) and
- •b) 6 or more tender joints (68 joint count) and
- •c) CRP greater than the upper limit of normal (result from screening visit sample
- •collection).
- •11) Drug stabilization requirements (except MTX): Informed consent must be
- •signed before making any changes in RA therapy if those changes are solely for
- •the purpose of this study.
- •a) All DMARDs (except MTX) should be discontinued at least 28 days prior to
- •treatment (Day 1).
- •-MTX monotherapy: Subjects who are treated only with MTX will not
- •require washout.
- •-Combination DMARD therapy: Subjects who are treated with MTX in
- •combination with another anti-rheumatic treatment (DMARD) will
- •require washout.
- •b) In the case of leflunomide, the subject can be washed-out with cholestyramine
- •according to manufacturer recommendations.
- •c) Oral corticosteroid treatment must have been reduced to a maximum equivalent dose of 10 mg prednisone daily for 28 days and stabilized for at least 25 out of 28 days, prior to treatment (Baseline i.e. Day 1).
- •12) Osteoporosis treatment:
- •Subjects taking treatments for the prevention of glucocorticoid-induced osteoporosis
- •(Calcium, vitamin D, Bisphosphonates) will be enrolled as long as their dose has been
- •stable for at least 3 months prior to randomization and remains stable during the entire double-blind period. Other concomitant osteoporosis treatments will not be permitted at randomization.
- •13) Men and women (not nursing and not pregnant) >= 18 years of age. Women of
- •childbearing potential are eligible if they are practicing effective contraceptive
- •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
- 另有 1 项未显示
排除标准
- •1)WOCBP unwilling or unable to use acceptable method to avoid pregnancy for entire study period & up to 10 weeks after study
- •2)WOCBP using prohibited contraceptive method
- •3)Pregnant or breastfeeding women
- •4)Women with +pregnancy test on enrollment or prior to study drug administration
- •5)Contraception for male subjects treated with protocol-permitted concomitant
- •medications during study should follow manufacturer’s recommendation for need to use contraception & permissible/recommended method(s)
- •6)Subjects who are impaired,incapacitated,or incapable of completing study related assessments
- •7)Subjects meeting diagnostic criteria for any other rheumatic disease
- •8)previous treatment with approved/investigational biologic RA therapy (infliximab, etanercept,anakinra,adalimumab,rituximab,Abatacept)
- •9)Active vasculitis of a major organ system with exception of rheumatoid nodules
- •10)current symptoms of severe,progressive, or uncontrolled renal, hepatic,hematological,gastrointestinal,pulmonary,cardiac,neurological,or cerebral disease,or other medical conditions that,in opinion of the investigator,might place subject at unacceptable risk for participation
- •11)Female subjects who have had breast cancer screening suspicious for malignancy & in whom possibility of malignancy cannot be reasonably excluded following additional clinical,laboratory or other diagnostic evaluations (Protocol Section 7.3.2.3)
- •12)history of cancer within last 5 years (other than nonmelanoma skin cell (NMSC) cancers cured by local resection). Existing NMSC cancers must be removed prior to dosing
- •13)Known current metabolic bone disorders other than osteoporosis or low bone mass
- •14)Vitamin D deficiency
- •15)Clinically significant drug or alcohol abuse
- •16)Subjects with any serious bacterial infection within last 3 months, unless treated & resolved with antibiotics, or any chronic bacterial infection
- •17)Subjects at risk for TB. Specifically subjects with:
- •-History of active TB within last 3 years even if treated
- •-History of active TB >3 years ago unless there is documentation
- •that prior anti-TB treatment was appropriate in duration & type
- •-Current clinical, radiographic or laboratory evidence of active TB
- •-Latent TB which was not successfully treated
- •18)Subjects with herpes zoster or CMV that resolved less than 2 months prior to signing ICF
- •19)Subjects with evidence of active or latent bacterial/viral infections at time of potential enrollment, including subjects with evidence of HIV, HPB or HPC infection detected during screening
- •20)Subjects with conditions that preclude accurate DXA measurements
- •-BMI >35 kg/m²
- •- Advanced scoliosis or spinal degenerative changes (osteoarthritis, sclerosis)
- •-Less than 3 lumbar vertebrae in range L1-L4 which are evaluable by DXA
- •interfering conditions include prevalent vertebral fracture, metal implants or spinal
- •-History of bilateral distal radius fracture
- •21)Subject who received live vaccines within 3 months of anticipated
- •1st dose of study medication or who will have need of live vaccine at any time
- •following Day 1 of study
- •22)History of severe or anaphylactic infusion reaction after receiving a biologic
- •agent, suspected to be associated with an immune response
- •23)Subjects who have at any time received treatment with Abatacept
- •24)Subjects who have at any time received treatment with biologic DMARD
- •(infliximab, etanercept, adalimumab, rituximab, or any investigational biologic)
- •25)Subjects that received treatment with a
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