Jusvinza in adult patients with Rheumatoid Arthritis from Camaguey and Eastern Provinces

Not Applicable

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Joint Diseases; Arthritis; Arthritis, Rheumatoid

• Registration Number: RPCEC00000433
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Last Update Posted: 19 August 2024
• Study Completion: 2025-06-18
• Results First Posted: 2026-06-18

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified