Rheumatoid arthritis
Conditions
Interventions
Jusvinza group (Experimental): Jusvinza+ Methotrexate + Prednisone + Folic acid
Jusvinza: 0.5 mg, by subcutaneous route, once a week for 4 weeks, followed by every 4 weeks for 20 weeks
Methotrexate: 12.5 mg, by subcutaneous route, once a week for 28 weeks
Prednisone: 7.5 mg, by oral route, daily for 28 weeks
Folic acid: 5 mg, by oral route, once a week for 28 weeks.
Placebo group (Control): Placebo + Methotrexate + Prednisone + Folic acid
Placebo: A placebo, by subcutaneous route, once a week for 4 weeks
Folic acid: 5 mg, by oral route, once a week for 28 weeks.
Prednisone
Folic Acid
Injections, Subcutaneous
Administration, Oral
Jusvinza,
Metotrexate
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.- Diagnosis of RA with evolution time greater than or equal to two years. 2.- Age between 19 and 80 years, both inclusive. 3.- Moderate clinical activity, evaluated by DAS28 > 5.10. 4.- Have = 2 swollen joints. 5.- CRP value = 5.10 mg/dL 6.- Have received six months of treatment with MTX in doses of 12.5 mg to 25 mg and be considered refractory to the product. 7.- Laboratory parameters within normal limits (considering the type of processing and equipment used in the CIMEQ clinical laboratory service) or outside the normal limit, which in the investigator's opinion are not clinically significant. The following lower limits are established as ceilings to allow the inclusion of patients: a)- Hemoglobin = 8.5 g/L, value justified by RA activity. b)- Hematocrit 0.28-0.40 in women and 0.28-0.44 in men. c)- White blood cell count = 3000/microliter = 3 x 109 /L. d)- Absolute neutrophil count = 1500/microliter = 1.5 x 109 /L. e)- Platelet count = 100,000/microliter = 100 x 109 /L. 8.- Have received treatment with prednisone (= 10 mg as a stable dose) in the last 8 weeks prior to inclusion in the study. 9.- Express and written willingness by the patient to enter the study, by signing the participation consent form.
Exclusion criteria
Exclusion criteria: 1.- Positive for human immunodeficiency virus (HIV). 2.- RA in mild or severe activity, according to the DAS28 index. 3.- Have 80 years. 5.- CRP value 10.0 mg during the previous eight weeks. 8.- No use of prednisone in the last 8 weeks prior to inclusion in the study. 9.- Positive serology for Hepatitis B or Hepatitis C 10.- Value of complementary clinical laboratory outside the normal range and clinically relevant. 11.- Previous treatment with Jusvinza for any reason or illness. 12.- Having participated as a patient included in phase I or phase II studies. 13.- Positive serology for SARS-CoV-2 (as long as it is considered an active pandemic and involves differentiated management of the sick subject). 14.- Pregnancy, puerperium or lactation period. 15.- 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). 16.- Male patient with a pregnant female sexual partner. 17.- Treatment with another investigational product at the time of inclusion. 18.- Previous treatment with another biological therapy. 19.- Complicated RA (systemic vasculitis, myocarditis, pericardial effusion with hemodynamic compromise, pleural effusion with respiratory compromise, antiphospholipid syndrome, renal amyloidosis, autoimmune hepatitis, digestive bleeding). 20.- Other rheumatic diseases of autoimmune origin that affect the osteomyoarticular system. 21.- Consumption greater than ¼ bottle of rum or a bottle of wine or three beers, with a frequency greater than three times a week. 22.- Drug-dependent patient. 23.- Concomitant chronic disease such as chronic renal failure (CRF), nephrotic syndrome, acute or chronic liver disease, chronic obstructive pulmonary disease (COPD), decompensated ischemic heart disease, hypertensive encephalopathy, cerebrovascular disease, diabetes mellitus with metabolic decompensation, acute peripheral arterial insufficiency and complications in other organs such as the kidney (Kinmestiel – Wilson, IRC, necrotizing papillitis). 24.- Feverish states due to severe infectious or septic processes, not associated with the evolution of the disease. 25.- Haematological disease. (Acute or chronic leukosis, lymphoma, plasma cell dyscrasias, coagulation disorders) 26.- Malignant neoplasm. 27.- Congenital or acquired immunodeficiency at the time of inclusion. 28.- Psychological, intellectual or sensory dysfunction that may prevent understanding and compliance with the requirements of the study according to the criteria of the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response type ACR20 (Decrease of at least 20% in the number of painful joints and in the number of swollen joints. Also, at least a 20% improvement in three of the five following parameters: 1) Patient's pain assessment. Evaluated on Visual Analogue Scale from 0 to 10, where 0=no pain and 10=maximum pain); 2) Patient's global assessment of disease activity (PGA). Evaluated on a scale from 0 to 10, where 0=no activity and 10=maximum activity; 3) Physician's global assessment of disease activity (Medical doctor(MD) global). Evaluated on a scale from 0 to 10, where 0=no activity and 10=maximum activity; 4) Patient self-assessed disability. Evaluated using the Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire on a scale of 0 to > 2, where 0= no disability and > 2= severe disability.; 5) Acute phase reactant: CRP or ESR). Measurement time: Weeks 4, 8, 12, 16, 20, 24, 28 and 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DAS28 scale (To calculate the DAS28, the following formula must be used: DAS28 = 0.56 (square root of the number of painful joints) + 0.28 (square root of the number of swollen joints) + 0.70 (acute phase reactant) + 0.014 (EGP)). Measurement time: Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 36. 2. Clinical activity of the disease by DAS28 scale (It is classified using the value of the DAS28 scale: Remission [0.60 and 2.80 – 10.00]; Moderate [> 10.00 – 22.00]; High [> 22.00]). Measurement time: Weeks 1, 2 and 3 5. Functional capacity (HAQ-DI questionnaire. Classification of disability in the patient HAQ-DI score in: 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: Week 0, 1. 2, 3, 4, 8, 12, 16, 20, 24, 28 and 36. | — |
Countries
Cuba
Contacts
Public ContactHugo Nodarse Cuni
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed