EUCTR2015-002127-26-IT进行中（未招募）1 期
Randomized, single-blind, controlled study of the anti-BAFF antibody belimumab or methylprednisolone treatment in hyperthyroid Graves' disease (GD) and active orbitopathy (GO) - BAFFI_14
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Male or female,18-75 years old; Smokers and non smokers. Women of childbearing potential should use adequate contraception (See Important Safety Information-Women of Child Bearing Potential” section for specific methods of contraception) during BENLYSTA treatment and for at least 4 months after the last dose. GO at first diagnosis or at the time of relapse, with detectable TSH receptor antibodies. Patients with moderate-severe active GO (clinical activity score 4/10 o 3/7) untreated or previously treated with i.v steroids withdrawn for at least 3 months. Not submitted to previous B cell depleting therapy. Euthyroid for at least 6-8 weeks, on either anti-thyroid medications (tyonamides) to control hyperthyroidism or L-thyroxine for replacement therapy for hypothyroidism. Patients will also be allowed to stay on propranolol treatment for the control of tachycardia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients with severe Graves’ orbitopathy (severe keratopathy, compression optic neuropathy and inflammatory optic neuropathy).Treatment with any B cell targeted therapy at any time. Previous oral or intravenous corticosteroid treatment in the last three months not exceeding a cumulative dose of 1 gr. Any immunosuppressant whether biologic or not. Plasmapheresis within 90 days prior to Day 0. Treatment with intravenous immunoglobulin. Azathioprine more than 100 mg/day within 30 days before screening. Administration of live vaccines given within 30 days prior to administration of (Day 0) or concurrently with Belimumab (During study). Splenectomy. Subjects at risk of haemorrhage that threatens a vital organ. History of a major organ transplant or hematopoietic stem cell/marrow transplant. History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. Required management of infections, as follows: currently on any suppressive therapy for a chronic infection, hospitalisation for treatment of infection within 60 days before Day 0, use of parenteral antibiotics within 60 days before Day 0. Pregnancy. Breast feeding. Known coronary artery disease. Significant cardiac arrhythmias. Severe congestive heart failure. Other serious chronic illness. Active infection. History of recurrent clinically significant infection or recurrent bacterial infections. History of sarcoidosis. Primary or secondary immunodeficiency. History of IgE-mediated or non-IgE-mediated hypersensitivity. Known anaphylaxis to mouse-derived proteins. Positive PPD without documentation of treatment for TB infection. Denied consent to HIV testing. Previous orbital radiotherapy, refusal of treatment. Patients with known allergy to paracetamol, difenidramine, hydrocortisone. Patients positive for HBsAg. Patients positive for HBcAb regardless of HBsAb status will undergo HBV DNA which if positive will be excluded. Patients positive at screening Hepatitis C antibody. Positive test for Human Immunodeficiency Virus (HIV) antibody at screening or historically. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater or equal to 3x upper limit of normal (ULN). Alkaline phosphatase and bilirubin >2xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is<35%). Grade 3 / 4 IgG deficiency and IgA deficiency (IgA < 10mg/dL). Lymphocyte count<500/mm3. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies. Major depression. Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk. Current drug or alcohol abuse or dependence.
研究者
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