EUCTR2014-005390-36-GB进行中（未招募）1 期
Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a stratified medicines approach to treatment. - BIO BEHÇET’S
The University of Liverpool0 个研究点目标入组 100 人开始时间: 2015年12月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •The inclusion criteria are adult individuals who are:
- •1. Diagnosed to have BD by International Study Group (ISG) criteria or International Criteria for BD (ICBD);
- •2. Have refractory disease as defined by the UK Centres of Excellence criteria (failure to respond to steroid and/or immunosuppressive therapy with significant or major organ-threatening disease) and therefore qualify for biologic therapy with either IFX or aIFN. A summary drugs pathway is attached as an appendix to the Protocol. Patients will have failed to respond to or have been intolerant of azathioprine at a dose of >2mg/kg (or comparable drug) and/or prednisolone at a dose of >40mg/day typically for more than three months, or with evidence of either organ threatening disease or unacceptable adverse events from immunosuppressive medication;
- •3. Able to give informed consent;
- •4. Have not previously received a biologic agent; and
- •5. Aged over 18 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The principal exclusion criteria are adult individuals who;
- •1. Have a contraindication to either IFX or aIFN (e.g., active infection, severe liver disease, neutropenia, previous malignancy);
- •2. Are not likely to comply e.g., cannot attend for assessments because of excessive travel requirements;
- •3. Express a strong preference for one of the two potential therapies.
- •4. Have heart disease or severe heart failure.
- •5. Have been diagnosed with Multiple Sclerosis.
- •6. Have evidence of infection with HIV.
- •7. . a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the study duration plus 6 months.
- •b) Women who are pregnant or breastfeeding.
- •c) Sexually active fertile men not using effective birth control if their partners are WOCBP.
- •Reproductive Status of Trial Participants
- •Definition of Women of Child-Bearing Potential (WOCBP)
- •WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below).
- •Post-menopause is defined as:
- •Women who have had amenorrhea for ? 12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL.
- •Women who have irregular menstrual periods and a documented serum FSH level > 35 mIU/mL.
- •Women who are taking hormone replacement therapy (HRT).
- •The following women are WOCBP:
- •Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
- •Women who are practicing abstinence.
- •Women who have a partner who is sterile (e.g. due to vasectomy).
- •WOCBP entering the trial must:
- •Be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 6 months after the last dose of study drug in such a manner that the risk of pregnancy is minimised. The decision about the appropriate methods to be used to prevent pregnancy should be determined by discussions with the study subject.
- •Have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
- •Must not be breast-feeding.
- •Sexually active fertile men entering the trial must:
- •Use effective birth control if their partners are WOCBP for the duration of the trial plus 6 months.
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