Rheumatoid Arthritis
Conditions
Interventions
Stage I: Four level doses of T1h (0.1, 0.2, 0.4 y 0.8 mg/Kg respectively) by Intravenous route [IV] (infusion in 200 mL of sterile 0.9% sodium chloride solution over 2 hours) once weekly for 12 weeks.
Antibodies, Monoclonal, Humanized
Methotrexate
Antibodies, Monoclonal
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who expressed in writing in its informed consent form available from participating in the clinical trial. 2. Age between 18 and 65, inclusive, of any gender or skin color. 3. Patient who has not previously been treated with monoclonal antibodies. 4. Patients with at least 1 year with active RA diagnosed according to ACR criteria (American College of Rheumatology) revised in 1987. 5. Patients without concomitant anti-rheumatic during the four weeks before the administration of MAb. 6. Patients with hemoglobin = 8.5 g / L, WBC> 3x109 cells / mL, platelet count> 100x109/mL and transaminase (TGP) within the normal reference values (UI). 7. Patients with 8 or more joints swollen at the time of starting treatment. 8. Patients with 8 or more joints painful at the time of starting treatment.
Exclusion criteria
Exclusion criteria: 1. Suffering from severe chronic concomitant Central Nervous System, Respiratory, cardiovascular, gastrointestinal tract or genitourinary system. 2. Suffering from any malignancy. 3. Suffering from an acute infection at the time of inclusion. 4. Suffering from a chronic infection. 5. Any Hematopoietic system disorder (congenital or acquired). 6. Suffering from other autoimmune rheumatic diseases that affect osteomioarticular system. 7. Pregnancy, childbirth and / or breastfeeding. 8. Patients who refuse to use contraception during the study. 9. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I: Safety, tolerability and optimal biological dose. Measuring time: 4th week after last T1h dose. Stage II: ACR50. Measuring time: 12nd week after last T1h dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, ACR20, ACR50, ACR 70. Measuring time: during 24 weeks of study | — |
Countries
Cuba
Contacts
Public ContactPatricia Hernández Casaña
Center of Molecular Immunology (CIM)
Outcome results
None listed