Post-CHIKV infection arthritis in chronic stage
Conditions
Interventions
Group A (Experimental): Jusvinza 0.5 mg every 24 hours, subcutaneously for 3 days in the first week, for 2 days in the second week and one dose per week in weeks 3 to 6 (9 doses in total).
Group B (Co
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 in the chronic stage of the disease, defined by persistent symptoms lasting more than 90 days after the onset of acute symptoms. 3. Presence of persistent arthritis affecting at least one joint and interfering with quality of life or daily functioning. 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) or outside the normal range, but not clinically significant in the investigator's judgment. The following lower limits are established as thresholds for patient inclusion: o Hemoglobin = 8.5 g/L, a value justified by RA activity. o Hematocrit 0.28 in women and 0.31 in men. o White blood cell count = 3000/µL = 3 x 10?/L. o Absolute neutrophil count = 1500/µL = 1.5 x 10?/L. o Platelet count = 100,000/µL = 100 x 10?/L. 6. Express and written consent from the patient to participate in the EC, through their signature on the participation consent form.
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of Chikungunya virus infection with a duration of <21 days (acute stage) or between 21 and 3 months (post-acute stage). 2. Clinically relevant, out-of-range clinical laboratory values. 3. Current treatment with Jusvinza. 4. History of allergy or known contraindication to the intervention product being evaluated in the clinical trial. 5. Previous or current treatment with another biological therapy (<3 months). 6. Current treatment with another investigational product. 7. Concomitant active infections that may explain the joint symptoms (e.g., active tuberculosis). 8. Confirmed diagnosis of malignancy. 9. Confirmed diagnosis of congenital or acquired immunodeficiency. 10. Confirmed diagnosis of hematological disease. (Acute or chronic leukemia, 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 complete the questionnaires 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 prevent procreation (condom or vasectomy). 15. Pregnancy, postpartum period, or breastfeeding.
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 8, Week 6, 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, 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 8, week 6, week 12, week 24. 3. Quality of life (SF-36 questionnaire. Assessed on a scale of 0 to 100, where 0 = worst health status and 100 = best health status. A scale that considers eight dimensions: Physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). Measurement time: At baseline, and Week 6. 4. Study of CD4+, CD25+, and CD127 lymphocyte subpopulations by flow cytometry (Commercially available reagents for labeling human Treg cells will be used. Biological sample type: whole blood. The result is the percentage of T cells expressing the CD4+CD25+CD127- phenotype. It will be considered positive when an increase greater than 1.5 is detected relative to time zero). Measurement time: At baseline and week 6 5. Quantification of proinflammatory cytokines (TNF alpha, IFN gamma, IL-6, IL-17 by ELISA assay using commercially available reagents in plasma or serum). Measurement time: At baseline and week 6 | — |
Countries
Cuba
Contacts
Public ContactYudisay Reyes Pelier
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed