Rheumatoid arthritis with moderate activity
Conditions
Interventions
Group I (control): Placebo + Methotrexate + Prednisone + Folic Acid
Group II (experimental): CIGB 814 (0,5 mg) + Methotrexate + Prednisone + Folic Acid
Group III (experimental): CIGB 814 (1,0 mg) + Me
Peptides
Methotrexate
Prednisone
Folic Acid
Injections, Subcutaneous
Administration, Oral
Tablets
Placebos
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR clinical response (ACR20, ACR50 or ACR70. ACR20 decrease at least 20% in the number of painful joints and in the number of inflamed joints, and a 20% improvement in 3 of 5 following parameters: 1-Assessment of pain by the patient; 2-Overall evaluation of the patient's disease activity; 3-Overall assessment of disease activity by the physician; 4-Evaluation of the patient's physical function, through a self-assessment instrument; 5-Determination of acute phase reactants (C-reactive protein, erythrocyte sedimentation). ACR50 decrease at least 50% in the number of painful joints and in the number of inflamed joints, and a 50% improvement in 3 of 5 parameters. ACR70 decrease at least 70% in the number of painful joints and in the number of inflamed joints, and a 70% improvement in 3 of 5 parameters). Measurement time: at baseline, Weeks 1, 2, 3, 4 and, Months 2, 3, 4, 5, 6 and 9. EULAR response (Assessment of clinical activity by DAS28. DAS28 2.6 and = 3.2; Light disease activity; DAS28> 3.2 e = 5.2 Moderate disease activity; DAS28> 5.2 Severe disease activity). Measurement time: at baseline, Weeks 1, 2, 3, 4 and, Months 2, 3, 4, 5, 6 and 9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Adverse Events-AE (Ocurrence of AE (Yes, No), Description of AE (event name), -AE intensity (mild, moderate, severe)). Measurement time: at baseline, in the first four weeks, and in the months 2, 3, 4, 5, 6 and 9 Laboratory test (Numerical values of hemochemical tests: hemoglobin, hematocrit, leukogram with differential, velocity of globular sedimentation and platelet count). Measurement time: at the beginning, in the first four weeks, and in the months 2, 3, 4, 5, 6 and 9. Immunological response: Quantification of inflammatory cytokine levels (IL-17, IFN? and TNFa). Measurement time: at baseline, months 6 and 9. Determination of C-reactive protein (values of test). Measurement time: at baseline, months 6 and 9. Citrullinated antibodies (values obtained by ELISA in patient sera). Measurement time: at baseline, months 6 and 9. Imaging response: Evaluation of the imaging changes (edema, erosion, synovitis) in the most affected hand of the patients through magnetic resonance imaging. Measurement time: at the beginning and in the months 6 and 9. Quality of life (Questionnaire SF36). Measurement time: at baseline, Weeks 1, 2, 3 and 4, Months 2, 3, 4, 5, 6 and 9. Clinical response according to SDAI (Simplified Disease Activity Index. High activity> 26, Moderate activity> 11.1 and 3.3 and 22, Moderate Activity> 10.0-22, Low Activity> 2.8 -10, Referral 2.8). Measurement time: Weeks 24 and 36. | — |
Countries
Cuba
Contacts
Public ContactLidia Gonzalez Mendez
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed