EUCTR2007-000760-24-CZ进行中（未招募）1 期
Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •Diagnosis of RA for at least 6 months (ARA 1987) who are either treatment-naïve or who had previously discontinued their RA-directed medication due to either intolerability or insufficient efficacy.
- •Active disease at screening and baseline as defined by:
- •At least 9 out of the 68 joints assessed as painful or tender on motion
- •At least 6 out of the 66 joints assessed as swollen
- •Morning stiffness of at least 45 min
- •C-reactive protein (CRP) =1.8 mg/dL Non-PMs
- •CYP2D6 Metabolizer status, confirmed by genotyping, prior to randomization
- •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
- •Functional RA class IV (ACR 1991)
- •RA treatment failure with 3 or more established DMARDs, immunosuppressant and newer biologic agents
- •Previous treatment within the following time periods before first intake of investigational product (IP):
- •Methotrexate - 6 weeks
- •Hydroxychloroquine, sulfasalazine, gold salts, penicillamine, azathiaprine, cyclosporine mycophenylate mofetil - 4 weeks
- •Leflunomide – 6 weeks
- •Receptor antagonists: etanercept, anakinra, abatacept – 4 weeks
- •Monoclonal antibodies – 12 weeks
- •Prior treatment with rituximab
- •Intra-articular corticosteroid injections less than 4 weeks before first intake of IP
- •Oral glucocorticoids greater than 10 mg prednisone (or equivalent) daily
- •Analgesics and NSAID/COX-2 inhibitor with daily dose(s) greater than
- •approved for treatment of RA
- •Patients with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint:
- •Pain condition with etiology other than from RA
- •History of an acute inflammatory joint disease other than RA
- •Refusal or inability to give informed consent
- •Patients likely to be non-compliant or unlikely to complete the study
- •Fever (oral temperature > 38oC), chronic infections or inter-current infections requiring antimicrobial therapy:
- •previous or active infection with hepatitis B or C or other liver disease
- •Known or suspected HIV/AIDs
- •Past or current treatment for tuberculosis
- •History of multiple allergic reactions to drugs
- •Presence or history of cancer
- •Congenital or acquired immunodeficiency
- •Drug or alcohol abuse within 2 years of study entry
- •Have a history of significant other concomitant illness that could interfere with the patient’s participation in the study
- •Abnormal laboratory tests:
- •Creatinine clearance < 30 cc/min
- •AST > 2 X ULN
- •ALT > 2 X ULN
- •Alkaline phosphatase > 2 X ULN
- •Conjugated bilirubin > 2 X ULN
- •Complete blood count: Hemoglobin < 8.5 g/dl
- •WBC < 3.5 x 109
- •Neutrophils < 1.5 x 109
- •Platelets < 100 x 109
- •Any investigational drug within a 60-day period or 5 half-lives
- •Organic neurologic disorder or somatic symptomatology
- •Organic gastrointestinal disorder or somatic symptomatology
- •Pregnant or breast-feeding women,
- •Women of childbearing potential not protected by effective contraceptive measures
- •Concomitant treatment with moderate or potent CYP2D6 inhibitors
- •Concomitant treatment with potent CYP3A4 inhibitors
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