ISRCTN20220821已完成未知
Combined immunotherapy and trophic adrenocortical stimulation in new onset autoimmune Addison?s disease
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 13 人开始时间: 2012年10月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
2019 results in https://doi.org/10.1210/clinem/dgz287 (added 30/10/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clear evidence of adrenocortical failure with subnormal cortisol response to 250 µg IV synacthen (peak cortisol <300nmol/l) plus either clinical or biochemical evidence to confirm elevated ACTH, or evidence of mineralcorticoid insufficiency
- •2. Basal or ACTH stimulated serum cortisol >50nmol/l
- •3. Patients are less than 4 weeks from first diagnosis of AAD
- •4. Positive serum 21-hydroxylase autoantibodies (>1.0 IU/l on RSR assay)
- •5. Normal or atrophic adrenal glands on CT scan
- •6. Willingness to travel to the Wilson Horne Immunotherapy Centre, Newcastle for study
- •7. Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration
- •8. Willingness to use secure contraception during and for 12 months post-treatment with rituximab ((women of childbearing potential)
- •For Part B, only the first 4 criteria are relevant
排除标准
- •1. Active viral illness, including HIV, Hepatitis B or C, shingles/Zoster
- •2. Recent or partially treated TB or unexplained radiographic abnormality on chest X-ray
- •3 .Previous use of immunosuppressive or cytotoxic drugs (excluding glucocorticoid)
- •4. Significant cardio-respiratory (inc. asthma), chronic renal or non-autoimmune liver disease
- •5. Pregnant or breastfeeding and with plan for pregnancy/ breastfeeding within 24 months
- •6. Known allergy or contraindication to synacthen, synacthen depot, rituximab or methylprednisolone
研究者
相似试验
进行中（未招募）
1 期
Rescue of Addison’s disease 2Autoimmune Addison's disease: autoimmune primary adrenal insufficiencyMedDRA version: 16.1 Level: PT Classification code 10052381 Term: Primary adrenal insufficiency System Organ Class: 10014698 - Endocrine disordersMedDRA version: 16.1 Level: LLT Classification code 10001335 Term: Adrenal cortex insufficiency System Organ Class: 10014698 - Endocrine disordersMedDRA version: 16.1 Level: LLT Classification code 10001342 Term: Adrenal cortical hypofunction System Organ Class: 10014698 - Endocrine disordersEUCTR2012-001682-33-GBewcastle upon Tyne Hospitals NHS Foundation Trust17
已完成
4 期
Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.Rheumatoid ArthritisNCT01966718Arthritis Treatment Center, Maryland8
已完成
1 期
Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)Metastatic CancerSolid TumorsNCT04574583National Cancer Institute (NCI)12
尚未招募
不适用
An integrated immunological-pharmacological approach to improve long-term allograft functiograft failurekidney transplantation10029149NL-OMON45414Inwendige Geneeskunde - Nefrologie en Transplantatie420
已完成
不适用
Combined therapy with immune-suppressive drug in children with immunoglobulin resistant Kawasaki diseaseKawasaki diseaseJPRN-UMIN000032096Dokkyo medical university52