Evaluation of the efficacy and safety of subcutaneous administration of CIGB-814 in combination with methotrexate in patients with rheumatoid arthritis.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 196 人开始时间: 2017年1月26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: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Diagnosis of Rheumatoid Arthritis with evolution time equal to or greater than 2 years.
•2. Moderate clinical activity, assessed by DAS28.
•3. Have received MTX at a stable dose of 12.5 to 25 mg over a period = 6 months prior to inclusion in the study (patient with inadequate response to treatment with Methotrexate).
•4. Age between 18 and 60 years, both inclusive.
•5. Laboratory parameters within normal limits or outside the limit of normality, which at the discretion of the investigator are not clinically significant.
•6. Female patient of childbearing age with negative pregnancy test and using effective contraceptive methods or male patient using effective methods to prevent procreation.
•7. Have received Prednisone (10-20 mg) and Folic Acid (5 mg) for a period = 6 months prior to inclusion in the study.
•8. Have received FAME prior to inclusion in the study.
•9. Expressed and written willingness by the patient to enter the study with his / her consent to participate.

•1. Pregnancy, puerperium or lactation period.
•2. Treatment with another product under investigation at the time of inclusion.
•3. Prior treatment with other biological therapy.
•4. Complicated rheumatoid arthritis.
•5. Other rheumatic diseases of autoimmune origin that affect the osteomioarticular system.
•6. Alcoholism.
•7. Drug-dependent patient.
•8. Concomitant chronic disease.
•9. Febrile states due to infectious processes. Or severe septic, not associated with the evolution of the disease.
•10. Hematologic disease.
•11. Malignant neoplasm.
•12. Congenital or acquired immunodeficiency at the time of inclusion.
•13. Intellectual or sensory psychological dysfunction that may impede the understanding and fulfillment of study requirements according to the criteria of the clinical investigator.

发起方

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