EUCTR2015-005564-41-DE进行中（未招募）1 期
An open label study to evaluate the safety and efficacy of 12 week treatment with CFZ533 in patients with Graves'disease - CCFZ533X2205
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •Main Inclusion Criteria:
- •1. Male and female patients 18 to 65 years of age included.
- •Women of child-bearing potential must be willing to use
- •highly effective methods of contraception during the study
- •treatment epoch and for 12 weeks after the last study
- •2. Grave's hyperthyroidism.
- •3. Patients must weigh at least 40 kg to participate in the study.
- •other protocol-defined inclusion criteria may apply
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main Exclusion Criteria:
- •1. History of treatment of Graves' disease with radio-iodine ablation or thyroidectomy and/or current treatment with anti-thyroid drugs (methimazole or propylthiouracil) within one week of starting the study treatment
- •2. History of hyperthyroidism not caused by Graves’ disease (e.g. toxic multinodular goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis) and/or history or presence of thyroid storm (fever, profuse sweating, vomiting, diarrhea, delirium, severe weakness, seizures, markedly irregular heartbeat, yellow skin and eyes (jaundice), severe low blood pressure, and coma).
- •3. Previous treatment with a B cell-depleting biologic agent or any other immune-modulatory biologic agent within 5 half-lives (experimental or approved).
- •4. History of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms.
- •5. History of primary or secondary immunodeficiency, including a positive HIV (ELISA and Western blot) test result.
- •6. History or evidence of tuberculosis by either of the following tests:
- •Positive PPD skin test (size of induration measured after 48-72 hours, and a positive result is defined as an induration of = 5mm or according to local practice/guidelines) OR
- •Positive QuantiFERON TB-Gold test
- •7. Plans for immunization with a live vaccine within a 2-month period before enrollment or during the study period.
- •8. Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, and/or cyclophosphamide within 3 months from baseline. Glucocorticosteroid therapy with prednisolone up to 10 mg daily is permitted if patients are on stable dose for more than 3 months before enrollment in the study.
- •9. Pregnant, breastfeeding females, and women of child bearing potential unless they are using highly effective contraception
- •other protocol-defined exclusion criteria may apply
研究者
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