EUCTR2007-000593-24-GB进行中（未招募）1 期
An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •Inclusion Criteria: Group A Only
- •1a. Naïve to either etanercept or adalimumab, or who may have received prior anti-TNF therapy and displayed an intolerance but is now considered to be appropriate
- •candidate for treatment with either etanercept or adalimumab.
- •Inclusion Criteria: Group B Only
- •1b. History (as documented in the patient’s medical records) of initial clinical response to either etanercept or adalimumab and a subsequent loss of clinical response. Initial clinical response is defined as attainment of Good or Moderate response by EULAR criteria during the first 3 months of anti-TNF therapy; the consistency of the response must be documented on at least two consecutive occasions separated by at least 4 weeks. Loss of response to therapy is defined as DAS 28 score = 4.5 and increase or worsening in DAS 28 by = 1.2 from lowest DAS achieved on anti-TNF therapy, in at least two consecutive evaluations separated by at least 4 weeks. A documented loss of response is required prior to study screening. Confirmation of loss of response will occur at the Screening Visit.
- •Inclusion Criteria: Groups A and B
- •Able and willing to give written informed consent and comply with the requirements
- •of the study protocol.
- •Diagnosis of RA at least 3 months prior to start of anti-TNF therapy, according to the
- •revised 1987 ACR criteria.
- •Age 18–80 years, inclusive.
- •If on corticosteroids, dose must be = 10 mg prednisone (or equivalent) for at least 2
- •weeks prior to baseline assessment.
- •Must have inadequate response to MTX at a dose of 10-25 mg/week (po or
- •parenteral) for = 12 weeks, of which the 4 weeks immediately prior to the baseline
- •visit have been at a stable dose.
- •Swollen joint count (SJC) = 4 (28 joint count), and tender joint count (TJC) = 4 (28
- •joint count) at baseline.
- •At screening, either: CRP = 0.6 mg/dL (6 mg/L) with high sensitivity assay OR ESR
- •At least one active joint that is appropriate for biopsy.
- •Positive for rheumatoid factor (RF) or anti-CCP.
- •If female, and of child-bearing potential, must agree to use a reliable form of
- •contraception (e.g., hormonal contraceptive, patch, intra-uterine device, physical
- •barrier) during the study and for 5 months following the last dose of prescribed
- •anti-TNF therapy.
- •If male, must agree to use (with his partner), a reliable form of contraception
- •(hormonal contraceptive, patch, intra-uterine device, physical barrier method),
- •during the study and for 5 months following the last dose of prescribed anti-TNF therapy.
- •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
- •Exclusion Criteria: Groups A and B
- •Patients with any of the following will be excluded from the study:
- •Any contraindication for entanercept or adalimumab treatment according to the
- •approved product label.
- •Pregnant or breast-feeding.
- •History of or current inflammatory joint disease or autoimmune disease other than RA.
- •Treatment with sulfasalazine, hydroxychloroquine, chloroquine, D-penicillamine,
- •auranofin, azathioprine, cyclosporine, or tacrolimus = 4 weeks prior to baseline, or
- •abatacept or leflunomide = 8 weeks before baseline.
- •Treatment with any investigational agent = 4 weeks prior to baseline or < 5 half-lives of the investigational drug or where persisting PD effect (eg, cell depletion) of
- •investigational therapy on target cells or pathways to RA (whichever is longer).
- •Previous treatment with alkylating agents or cell-depleting therapies, including
- •investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19,
- •anti-CD11a, Blys, BAFF, anti-CD22, and anti-CD20).
- •Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column
- •within 6 months of baseline.
- •Intra-articular or parenteral corticosteroids = 2 weeks prior to baseline.
- •Intra-articular treatment of the joint selected for biopsy within 3 months of baseline
- •History of heart failure.
- •Evidence of significant uncontrolled concomitant diseases such as neurological,
- •cardiovascular, renal, hepatic, endocrine, or gastrointestinal disorders which, in the
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