Safety and pharmacokinetics of CIGB-814 in patients with rheumatoid arthritis

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 18 人开始时间: 2017年2月16日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment

•1. Patients diagnosed of rheumatoid arthritis active = 2 years
•2. Patients with moderate disease activity (DAS28)
•3. Patients that did not respond to conventional treatment
•4. Patients evaluated in ex vivo assays with CIGB-814
•5. 19 = Age < 65
•6. Laboratory parameters within normal limits
•7. Female patient of gestation age with negative pregnancy test and use effective contraceptive methods or male patient employing effective methods to prevent procreation.
•8. Patient complimenting a previous period of washing, which ranged from 2 to 4 weeks, according to previous treatment with or without FARME
•9. Personal interest express written by the patient enrolled in the study with his/her signature consent to participate.

•1. Pregnancy, postpartum or breastfeeding.
•2. Allergy to paracetamol.
•3. Treatment with another investigational product at the time of inclusion.
•4. Rheumatoid arthritis burned.
•5. Complicated Rheumatoid arthritis
•6. Other rheumatic autoimmune diseases affecting the osteomioarticular system.
•7. Alcoholism.
•8. Patient drug-dependent.
•9. Concomitant Chronic Diseases
•10. States due to severe febrile infectious or septic processes not associated with disease progression.
•11. Hematologic disease.
•12. Malignancy.
•13. Congenital or acquired immune deficiency at the time of inclusion.
•14. Psychological intellectual or sensory dysfunction that may impede understanding and compliance with the requirements of the study.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana