Rheumatoid arthritis
Conditions
Interventions
Jusvinza group (experimental): Jusvinza 0.5 mg, by subcutaneous route, during 6 months. The first month a weekly frequency (4 administrations). From the second to the sixth month with a monthly freque
Prednisone
Injections, Subcutaneous
Administration, Oral
Jusvinza, Metotrexate
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), Havana City
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Time of RA evolution equal to or greater than 2 years. 2) Moderate or severe clinical activity, assessed by DAS28. 3) Age greater than 19 years. 4) Laboratory parameters within normal limits or outside the normal limits, which at the investigator's criteria are not clinically significant (Hematological (Hematocrit 0.28-0.40 in women and 0.28-0.44 in men, Leukocyte count = 3000/µL = 3 x 10*9 /L, Platelet count = 100000/µL = 100 x 10*9 /L), Biochemicals (Hepatic: ALAT (TGP), ASAT (TGO), alkaline phosphatase (upper normal reference limit), Glycemia (normal reference value), Bilirubin (normal reference value), serum creatinine (normal reference value). 5) NON-pregnant female patient who uses effective contraceptive methods (intrauterine devices, barrier methods or tubal ligation) or male patient who uses effective methods to avoid procreation (condom or vasectomy). 6) Patient who, before being included, received treatment with DMARDs, including MTX (12.5-25 mg) and Prednisone (5-20 mg) (among the DMARDs indicated/received by the patient prior to inclusion in the study, the following could be mentioned: gold salts, D-penicillamine, sulfasalazine, chlorambucil, cyclophosphamide, cyclosporine A, azathioprine, antimalarials, leflunomide). 7) Patient´s expressed and written willingness to enroll in the study by signing the consent to participate.
Exclusion criteria
Exclusion criteria: 1) Pregnancy, puerperium or lactation period. 2) Treatment with another investigational product at the time of inclusion. 3) Serious rheumatoid arthritis (systemic vasculitis, myocarditis, pericardial effusion with hemodynamic compromise, pleural effusion with respiratory compromise, antiphospholipid syndrome, renal amyloidosis, autoimmune hepatitis, digestive bleeding). 4) Mono-articular Rheumatoid Arthritis. 5) Other rheumatic diseases of autoimmune origin that affect the osteomyoarticular system. 6) Alcoholism. 7) Drug-dependent patient. 8) Concomitant chronic disease such as chronic renal failure (CKD), nephrotic syndrome, acute or chronic liver disease, chronic obstructive pulmonary disease (COPD), decompensated ischemic heart disease, hypertensive encephalopathy, cerebrovascular disease (CVA), diabetes mellitus with metabolic decompensation, arterial insufficiency acute peripheral and complications in other organs such as kidney (Kinmestiel - Wilson, Necrotizing papillitis). 9) Febrile states due to severe infectious or septic processes not associated with the evolution of the disease. 10) Hematological disease (acute or chronic leukosis, lymphoma, plasma cell dyscrasias, coagulation disorders). 11) Malignant neoplasm. 12) Congenital or acquired immunodeficiency at the time of inclusion. 13) Sensory or intellectual psychological dysfunction that may prevent understanding and compliance with the study requirements according to the clinical investigator's criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Clinical response type ACR20 (Response is considered when the patient has 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; 2. Patient's global assessment of disease activity (EGP); 3. Physician's global assessment of disease activity; 4. Evaluation of the patient's physical function, using a self-assessment instrument; 5. Determination of acute phase reactants (C-reactive protein or erythrocyte sedimentation rate)). Measurement time: At week 16. 2) Incidence of Adverse Effects (they will be classified according to Type, Intensity (mild, moderate, severe, serious or death), Gravity (Serious or non-serious), Duration (start and end dates of each AE), Action adopted (it will be recorded if there were no changes or definitive interruption of the treatment), Result (recovered, improved, persists, worsened, leaves sequelae or death of the subject), Causal relationship (very probable, probable, possible, improbable, not related, not evaluable), Treatment indicated for the adverse event (it will be specified the treatment that each patient will receive for the AE occurred) Measurement time: from the start of treatment until the final evaluation at week 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response Variables 1. Evaluation of the clinical activity of RA according to DAS28 (calculation of DAS-28 using the formula: DAS28 = 0.56 (square root of the number of painful joints) + 0.28 (square root of the number of swollen joints) + 0.70 (ESR) + 0.014 (EGP). If the patient has DAS28 5.2: Severe disease activity)). Measurement time: At baseline and, At weeks 16 and 28. 2. Evaluation of the response to treatment according to EULAR Criteria (The response to treatment will be determined according to the following: Equal or greater than 1.2: Good Response; 0.6 to 1.2: Moderate Response; Less than 0.6: Poor therapeutic response) Measurement time: At weeks 16 and 28. 3. Evaluation of the Clinical Activity of RA according to CDAI ((in patients for whom DAS28 value cannot be calculated) Disease activity will be determined according to CDAI = 2.8: Remission; 2.8 22.0: High). Measurement time: At baseline and, At weeks 16 and 28. Laboratory, molecular and cellular variables 1. Hematological: Hemoblogin (g/L), Hematocrit, Biomarkers of inflammation (Leukocyte count (x10*9/L), Neutrophils%, Lymphocytes%, Monocytes%, Eosinophils%, Basophils%, Count of platelets (x10*9/L)), Erythrocyte sedimentation rate (mm/h) and C-reactive protein (mg/L). Measurement time: Before treatment, weeks 16 and 28. 2. Lipid profile (Value of total cholesterol concentration in blood (mmol/L), Triglycerides (mmol/L), HDL-cholesterol (mmol/L), LDL-cholesterol (mmol/L)). Measurement time: At baseline, and at weeks 16 and 28. 3. Blood biochemistry (glycemia ( mmol/L), ALAT (U/L), ASAT (U/L), GGT (U/L), total bilirubin (µmol/L), serum alkaline phosphatase (U/L), total protein (µmol/L) and creatinine (µmol/L)) Measurement time: At baseline, and At weeks 16 and 28. 4. Cituria (altered or normal). Measurement time: At baseline, and at weeks 16 and 28. | — |
Countries
Cuba
Contacts
Public ContactMaria Domínguez Horta
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed