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 sites196 target enrollmentJanuary 26, 2017

Overview

No summary available.

Registry

who.int

Start Date

January 26, 2017

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

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

•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.