EUCTR2006-001859-35-GB进行中（未招募）1 期
Abatacept in ANCA associated vasculitis: ABAVAS - ABAVAS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Patients with Acute AAV, presenting at first diagnosis or relapse (not grumblers, to maximize effect seen), defined by clinical presentation, ANCA positivity (anti-MPO or anti-PR3 positive) and a BVAS score of > 8.
- •2. Males and females (not nursing and not pregnant) at least 18 years of age. Women of child bearing potential are eligible if they are practicing effective contraceptive measures
- •3. Written informed consent given
- •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
- •1. Subjects with severe life-threatening disease, i.e. lung haemorrhage at the time of presentation, renal impairment with SCr>150 mcmol/l, or severe CNS dysfunction thought to be due to vasculitis
- •2. Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic,
- •hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease,
- •or other medical conditions that, in the opinion of the investigator, might place the
- •subject at unacceptable risk for participation in this study.
- •3. Subjects with any other non-vasculitic multisystem autoimmune disease.
- •4. Subjects with any serious acute bacterial infection unless treated and completely resolved with antibiotics prior to enrollment
- •5. Subjects with any severe chronic or recurrent bacterial infection, e g. bronchiectasis, osteomyelitis, chronic pyelonephritis
- •6. Subjects with Hepatitis B or C or HIV.
- •7. Subjects with Herpes zoster infection that resolved less than 2 months prior to enrollment.
- •8. Subjects who have received any live vaccines within 3 months of the first dose of study medication or who will have need of a live vaccine at any time in the year following enrollment
- •9. Subjects with current clinical or laboratory evidence of active or latent tuberculosis (TB) and subjects with a history of active TB treated within the last 3 years should be excluded.
- •Subjects who received treatment for active TB greater than 3 years ago may be eligible for inclusion in this study if there is documentation of the prior anti-TB treatment confirming that it was appropriate in duration and type.
- •10. Subjects with any previous malignancy, with the exception of non-melanoma skin malignancies, adequately treated previously
- •11. Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional
- •clinical, laboratory or other diagnostic evaluations. Mammograms (females only)
- •must be performed within 6 months of study entry or if documentation is not on file
- •12. Pregnancy or breast feeding. Adequate contraception is necessary;
- •13. Subjects with MTX treatment in prior 3 months
- •14. Subjects with allergies to study medications.
- •15. Prior therapy with rituximab within the last 6 months (CD19 count must be normal before enrollment regardless of time of last dose). ; anti-TNF therapy, or IL-1 receptor antagonists within the last 3 months.
- •16. Subjects participating concurrently in another clinical trial.
- •17. Subjects with a history of intolerance to methotrexate.
- •18. Subjects who have at any time received treatment with abatacept.
- •19. Subjects who have received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.
- •20. Subjects with any of the following laboratory values:
- •- Hgb < 8.5 g/dL.
- •-WBC < 3,000/mm3 (3 x 109/L)
- •-Platelets < 100,000/mm3 (100 x 109/L).
- •-Serum ALT or AST > 2 times upper limit of normal.
研究者
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