Rheumatoid Arthritis
Conditions
Interventions
Group I (Experimental): CIGB-814, dose of 1 mg by subcutaneous route, once a week for the first four weeks and monthly the remaining five months of treatment.
Group II (Experimental): CIGB-814, dose o
Peptides
Injections, Subcutaneous
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe Adverse Events (EA) with very probable / certain or probable causal relationship with product administration (serious / serious "seriousness" with "probable", "very likely / safe" causation). Measurement time: weekly (1st month) and months 2, 3, 4, 5, 6, 9 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relating to safety: Adverse Events-AE (Type of AE, description of AE), Time between time of administration and the occurrence of AE (hours and minutes or days), Duration of AE (date of onset and duration of AE in days or hours and (Severe / Serious or Non-Severe / Non-Severe), Intensity of AE (Mild, Moderate or Severe), Causal Relationship (Not Evaluable / Unclassifiable, Unrelated, unlikely, probable, likely, very likely / safe), Attitude followed by onset of AE (continuing or stopping treatment), EA treatment (according to AE intensity), AE outcome). Measurement time: weekly (1st month) and months 2, 3, 4, 5, 6, 9 and 12. Relating to Pharmacokinetics: Maximum concentration (Cmax), Time at which Cmax (Tmax) is reached, Average life time (T ½), Area under the curve (AUC). Measurement time: before starting the treatment, after the 1st dose at 30 min, at 1 hr, at 1 ½ hr, at 2 hrs, at 4 hrs, at 6 hrs, at 8 hrs, at 12 hrs, at 18 hrs and 24 hours. Relating to the effect: Clinical response according to ACR (ACR20, ACR50, ACR70) Measurement time: Week 28, Month 9, Month 12. Clinical response according to DAS28 (DAS28 2.6 and DAS28 3.2 and DAS28 5.2)). Measuring time: Week 28, Month 9, Month 12. Sub lymphocyte populations (CD4 + CD25 + Foxp3 + by flow cytometry). Measuring time: 24 h Determination of cytokines (TNFa, IFN?, TGFß, IL-1, IL-2, IL-10 and IL-17). Measuring time: Week 28, Month 9, Month 12. Quality of life (Questionnaire SF-36). Measuring time: week 28, Month 9, Month 1 | — |
Countries
Cuba
Contacts
Public ContactDinorah Prada Hernandez
National Center for Rheumatology. Clinical Hospital “10 de Octubre”
Outcome results
None listed