Rheumatoid Arthritis
Conditions
Interventions
Four level of dosis of humanized Anti-CD6 MAb T1h Level 1: 0.1 mg/Kg Level 2: 0.2 mg/Kg Level 3: 0.4 mg/Kg, and Level 4: 0.8 mg/Kg It begins in the lower level. Each patient receives a total of 6 admi
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Administration, Intravenous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Patients who expressed in writing in its informed consent form their willingness to participate in the clinical trial. 2. Age over 18 and under 70 annos annos, of either sex or race. 3. Patient who has not previously been treated with monoclonal antibodies. 4. Patients without concomitant anti-rheumatic during the four weeks before the administration of MAb and until 4 weeks after completing the administration of the last dose of mAb (only able to receive the paracetamol as a painkiller). 5. Patients with hemoglobin> 10 g / L, WBC> 3x109 cells / mL, platelet count> 100x109/mL and transaminase (GPT) within the normal reference values (UI).
Exclusion criteria
Exclusion criteria: 1. Functional class IV according to Steinbrocker's criteria 2. Intercurrent infection. 3. Concomitant severe chronic disease (lung, heart, liver or kidney). 4. Pregnancy, childbirth and/or breastfeeding. 5. Female patients of childbearing age who do not have a negative pregnancy diagnosis and / or refuses to use an IUD as contraceptive method for as long as the extension of the study. 6. Patients who not meet the inclusion criteria. 7. Patients with history of severe allergies. 8. Patients with psychological dysfunction, intellectual or sensory impairment, that not allow to understand and compliance with study requirements according to criteria of the Principal Investigator. 9. Patients with any type of malignancy desease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security of T1h in the maximum dose level, expressed as no incidence of severe adverse events, no immunogenicity and no signs of opportunistic infections. Expression of ACR20. Measuring Time: 1st and 4th weeks after the last dose of T1h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expression of ACR50. Measuring Time: 1st and 4th weeks after the last dose of T1h. | — |
Countries
Cuba
Contacts
Public ContactPedro Rodríguez Rodríguez
Center of Molecular Immunology (CIM)
Outcome results
None listed