EUCTR2006-004140-23-BG进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA
Serono International S.A.0 个研究点目标入组 288 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 288
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
- •To be eligible for inclusion into this trial, subjects must fulfil all of the following criteria at the time of screening, unless stated otherwise:
- •1. Rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria, with a disease history of at least one year.
- •2. Male or female >or=18 years of age at time of Informed Consent.
- •3. Active RA as defined by:
- •- >or= 8 swollen joints (66-joint count),
- •- >or= 8 tender joints (68-joint count), and
- •- CRP >or=10 mg/L (central laboratory).
- •4. Failure of at least one TNFa antagonist therapy (previously or at the time of screening), defined as having persistent disease activity with a minimum of 8 swollen and 8 tender joints despite treatment with etanercept, infliximab or adalimumab at an approved labelled dose for >or= 3 months. Subjects who have discontinued TNFa antagonist therapy due to intolerance without associated lack of efficacy are not considered to satisfy this criterion.
- •Subjects with previous treatment failure must have documentation of the treatment failure provided by the treating physician, with a similar benchmark of minimally acceptable disease severity.
- •5. Current use of at least one DMARD at a stable dose, defined by use for at least 3 months before SD 1 with no changes in dosing regimen in the 28 days before Study Day 1 (SD 1, defined as the day of randomisation and first Investigational Product administration).
- •6. Rheumatoid factor (RF) positivity according to central laboratory criteria.
- •7. Written informed consent (obtained before any trial-related procedure). Subjects must review and understand the Informed Consent Form, and must fully understand requirements of the trial and be willing to comply with all trial visits and assessments.
- •8. For women, willingness to use adequate double contraception (i.e., two independently effective methods) for 4 weeks before randomisation and during the trial and for 3 months after the trial. These requirements do not apply to women who are surgically sterile or sexually inactive or who are post-menopausal for at least one year.
- •9. For women of childbearing potential or for those who are post-menopausal for less than one year, a negative urine pregnancy test.
- •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
- •To be eligible for inclusion in this trial, the subjects must not meet any of the following criteria at the time of screening:
- •1. Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject’s participation to the trial or that could interfere with the trial objectives, conduct or evaluation.
- •2. Treatment with rituximab within 2 years before SD 1.
- •3. Any previous treatment with abatacept or belimumab.
- •4. Use of etanercept within 28 days before SD 1, or of infliximab or adalimumab within 60 days before SD 1.
- •5. Participation in any interventional clinical trial within the 6 months before SD 1 (or within 5 half-lives of the investigated compound before SD 1, whichever is longer).
- •6. Methotrexate dose regimen > 25 mg/week.
- •7. Prednisone dose regimen > 10 mg/day (or equivalent) or change in steroid dosing regimen within 28 days before SD 1.
- •8. Change in NSAID dosing regimen within 28 days before SD 1.
- •9. Any current active infection, including herpes zoster or Epstein-Barr virus.
- •10. Positive HIV, hepatitis B or hepatitis C serology.
- •11. History or presence of active or latent tuberculosis as defined by national recommendations.
- •12. Opportunistic infection in the last 3 months.
- •13. History of chronic infections requiring repeated antibiotic treatment.
- •14. Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).
- •15. History or presence of uncontrolled or New York Heart Association class 3 or 4 congestive heart failure.
- •16. History of cancer, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia or carcinoma in situ of the skin or cervix.
- •17. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AP) level > 2.5 x ULN or total bilirubin > 1.5 x ULN.
- •18. Inadequate renal function, defined by serum creatinine > 1.5 x ULN.
- •19. Clinically significant abnormality in any haematological test (for example, haemoglobin < 5.5 mmol/L, WBC < 2.5 x 109/L, platelets < 75 x 109/L).
- •20. Serum IgG, IgA or IgM below the lower limits of normal as defined by the central laboratory.
- •21. Clinically significant abnormality on a chest X ray performed within 3 months before SD 1 or on ECG performed at screening.
- •22. Hypersensitivity to any of the components of the formulated atacicept or to structurally similar compounds.
- •23. Immunisation with live vaccines or Ig treatment within one month before SD 1 or need for such treatment during the trial period (including follow-up).
- •24. Planned major surgery (e.g., joint replacement) during the trial period (including follow-up).
- •25. Breastfeeding (for female subjects).
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