Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes

Exclusion Criteria

• •DM2 diagnosed since more than 10 years;
• •Ongoing Acute infection or chronic infection, which has one or more of following:
• •* Increased levels of C-reactive protein \> 30 mg / L
• •* fever
• •* Ongoing treatment with antibiotics ;
• •Chronic granulomatous infections (ie. tuberculosis diagnosed by radiography or by laboratory tests)
• •History of recurrent infections or presence of diseases that induce to infections;
• •C-peptide values \<0.5 ng / mL ( 0.1665 nmol / L)
• •presence of neutropenia ( WBC \< 2000/mm3 ) or anemia (hemoglobin \< 11g/dL for man and 10g/dl for the woman) ;
• •presence of one or more contraindication indicate in SmPC of study drug (anakinra);
• •presence of one or more contraindication indicate in SmPC of control drug (inhibitors of TNF -alpha ; ATC L04AB);
• •presence of one or more contraindications to treatment with methotrexate ;
• •previous ischemic attack or myocardial infarction;
• •heart failure NYHA class III or IV;
• •hepatic or progressive liver disease ( values of ALAT / ASAT increased by at least two -fold compared to normal limits );
• •pregnant, or women not using contraceptive measures;
• •breast-feeding;
• •participation in another clinical study up to 6 months before randomization;
• •depressive syndrome or other serious psychiatric illness that, in the opinion of the physician, may preclude participation in the study;
• •presence of known malignancy ;
• •Clinically significant history of alcohol abuse or drug addiction , that, in the opinion of the physician, may preclude participation in the study;
• •any condition that, in the opinion of the physician, precludes the possibility of using the study drug (anakinra , Kineret ) or the control drug (inhibitors of TNF alpha; L04AB ATC ) in compliance with SmPC indications ;
• •any other condition or laboratory parameter that , in the opinion of the physician, precludes the subject's participation in the study.