Atritis in post-acute Chikungunya virus infection
Conditions
Interventions
Group A (Experimental): Jusvinza 0,5 mg c/ 24 hours, during 4 days in the first week, , and Jusvinza 0,5 mg one dose per week, in weeks 2 and 3 (Total: 6 doses), subcutaneous route.
Grupo B (Experime
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), Havana City
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of Chikungunya virus infection. 2. Patients who go through the post-acute phase of the disease defined by the presence of persistent symptoms between the range of 21 and 90 days after the onset of acute symptoms. 3. Persistent arthritis that affects at least one joint and interferes with quality of life or daily function. 4. Age between 19 and 80 years. 5. Laboratory parameters within normal limits (considering the type of processing and equipment used in the clinical laboratory service) or outside the normal limit, which in the opinion of the investigator are not clinically significant. The following lower limits are established as ceilings to allow the inclusion of patients: - Hemoglobin = 8.5 g/L, value justified by RA activity. -Hematocrit 0.28 in women and 0.31 in men. -Leukocyte count = 3000/L = 3 x 109/L. -Absolute neutrophil count = 1500 / uL = 1.5 x 109 /L. -Platelet count = 100000 /uL = 100 x 109 /L. 6. Express and written voluntariness by the patient to participate in the clinical trial, by signing the consent to participate
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of Chikungunya virus infection with an evolution time 90 days (chronic phase) 2. Complementary value of clinical laboratory outside the normal range and clinically relevant. 3. Ongoing treatment with Jusvinza. 4. History of allergy or known contraindication to the intervention product to be evaluated in the clinical trial. 5. Previous treatment with another biological therapy (< of 3 months) or ongoing. 6. Ongoing treatment with another investigational product. 7. Active concomitant infections that may explain joint symptoms (e.g., active tuberculosis). 8. Confirmed diagnosis of malignancy. 9. Confirmed diagnosis of congenital or acquired immunodeficiency. 10. Confirmed diagnosis of hematologic disease. (Acute or chronic leukosis, lymphoma, plasma cell dyscrasias, coagulation disorders) 11. Complicated chronic diseases 12. Confirmed diagnosis of alcoholism or drug addiction. 13. Patient with intellectual or sensory psychological dysfunction who cannot understand and/or comply with the questionnaires posed in the study, according to the clinical investigator's criteria. 14. Female patient of childbearing age, who does not use effective contraceptive methods (intrauterine devices, barrier methods or tubal ligation) or male patient who does not use effective methods to avoid procreation (condom or vasectomy). 15. Pregnancy, puerperium or breastfeeding period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical activity of the disease according to the DAS28 scale (DAS28 scale: Remission (3.20 to = 5.10); and High activity (> 5.10)). Measurement time: At baseline, day 4, week 4, week 12, and week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of the intensity of pain by the patient. For the evaluation scale, a score (0-10) will be considered, going through the categories without pain (0), mild pain (2), moderate (4), severe (6), very severe (8) and maximum pain (10). Measurement time: At baseline, day 8, week 6, week 12, and week 24. 2. Classification of disability in the patient (HAQ-DI. Score No disability 0.000 Mild to moderate 0.000 to 1.000 Moderate to severe 1.001 to 2.000 Severe to very severe > 2.000). Measurement time: At baseline, day 4, week 3, week 12, and week 24. | — |
Countries
Cuba
Contacts
Public ContactLeyanis Hernandez Frometa
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed