EUCTR2016-003360-39-DE进行中（未招募）1 期
Safety and efficacy of Abatacept in patients with treatment-resistant sarcoidosis - ABASARC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent
- •2. Ability to understand the nature, significance and consequences of the study and to comply with them
- •3. Age 18 years or above; male or female patients
- •4. Diagnosis of sarcoidosis according to the current applicable ATS/WASOG guidelines
- •5. Immunosuppressive therapy (= 5 mg prednisolone equivalent per day or any additional immunosuppressive therapy independently of the steroid dose) within the last 3 months prior screening for pulmonary involvement as defined by one of the following
- •a. Radiographic alterations in HRCT compatible with sarcoidosis
- •b. Lung function impairment caused by sarcoidosis (e.g. reduced TLC, FVC, reduced DLCO, reduced pO2 at rest or exercise-induced)
- •6. King’s Sarcoidosis Questionnaire (KSQ), GHS L module: Score < 80
- •7. Need for therapy escalation beyond 5 mg prednisolone equivalent according to the physician’s appraisal, e.g.:
- •a. Disease activity only controlled by > 5 mg prednisolone equivalent
- •b. Disease progression under established immunosuppressive therapy according to clinician’s appraisal (e.g. lung function deterioration, CT-graphic progression, increase of activity parameters)
- •c. Need for change of immunosuppressive therapy because of therapy-associated side effects
- •8. Elevated sIL2 receptor levels and/or elevated Neopterin as sign of T-cell activation within 6 months prior to date of informed consent
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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), for example but not limited to active hepatitis B and C, typical or atypical mycobacteriosis or herpes zoster infections.
- •9. History of or active psychiatric disease (including known history of or current active abuse of drugs, chemicals or alcohol) 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. Examples are cardiovascular (e.g. severe uncontrolled hypertension, instable angina pectoris, severe ischemic heart disease), central nervous system (e.g. stroke, dementia), hepatic, renal, endocrine (e.g. uncontrolled diabetes), gastrointestinal (e.g. complicated diverticulitis, Crohn’s disease, colitis ulcerosa)
- •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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