DRKS00011660已完成2 期
Safety and efficacy of Abatacept in patients with treatment-resistant sarcoidosis - ABASARC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Signed written informed consent
- •2. Diagnosis of sarcoidosis according to current applicable ATS/WASOG guidelines
- •3. Immunosuppressive therapy (>5mg prednisolone equivalent per day or additional immunsuppressive therapy) within the last 3 months prior screening
- •4. Kings Sarcoidosis Questionnaire (KSQ): Score < 80
- •5. Need for therapy escalation beyond 5 mg prednisolone equivalent according to the physician’s appraisal
- •6. Elevated sIL2 receptor levels and /or elevated Neopterin as sign of T-cell activation within 6 months prior to date of informed consent
排除标准
- •1. Severe lung functional impairment according to the treating physician interfering substantially with participation in the trial
- •2. End stage fibrotic lung disease without expected improvement to immunosuppressive therapy as judged by the treating physician
- •3. Concomitant lung disease (e.g. COPD, asthma) that interferes with clinical assessment as judged by the treating physician
- •4. Concurrent immunosuppressive therapy other than corticosteroids and impossibility to allow a sufficient wash-out phase
- •5. For biologicals a wash-out phase of two months is mandatory
- •6. Previous treatment with Abatacept
- •7. Treatment with another investigational drug within 4 weeks or 5 half-lives prior to first application of trial medication
- •8. Recurrent or active current bacterial, viral or fungal infection (excluding fungal infections of the nails)
- •9. History of or active psychiatric disease interfering with the safe participation in the study
- •10. History of or current primary or secondary immunodeficiency that could not be attributable to treatment-related immunodeficiency
- •11. Serious uncontrolled concomitant diseases not caused by sarcoidosis
- •12. Known malignancy or high clinical suspicion on malignant disease
- •13. Lymphoma within the last five years
- •14. Contraindications against treatment with Abatacept
- •15. Simultaneous application of live vaccines
- •16. Simultaneous participation in other interventional clinical trials
- •17. Pregnancy indicated by positive urine pregnancy test
- •18. Breast-feeding patients
- •19. Fertile patients refusing to use safe contraceptive methods during the study
研究者
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