ESAR-814 Study

Phase 2

Conditions: Rheumatoid arthritis with moderate activity
Arthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Skin and Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Registration Number: RPCEC00000230

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 196

Inclusion Criteria

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.

Exclusion Criteria

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.