Evaluation of Safety and Efficacy of T1h (anti-CD6) as Monotherapy and in Combination with Methotrexate in Patientes with Rheumatoid Arthritis

Center of Molecular Immunology (CIM)0 个研究点开始时间: 2010年12月27日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Other. Purpose: Treatment

•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.

•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.

发起方

Center of Molecular Immunology (CIM)