rheumatoid arthritis and type 2 diabetes mellitus as comorbidity. MedDRA version: 14.1 Level: LLT Classification code 10037740 Term: RA System Organ Class: 100000004859 MedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age=18 years (for males and females; •Previous diagnosis of rheumatoid arthritis fulfilled American College of Rheumatology/EULAR criteria for RA;•diabetes mellitus type II diagnosed according to American Diabetes Association criteria with a duration of more than 6 months;•patients with an inadequate response to previous treatment with methotrexate (determined on the basis of the evaluation of the physician);•BMI7%3.2;•Patients previously treated with other bio, after a wash-out period of 1 months;•Patients don’t have changes in either types or doses of hypoglycaemic medications during the 3-month period preceding the study;•Patients don’t have changes in either types or doses of medications during the 1-month period preceding the study;•absence of signs and symptoms of ischemic heart disease;•Written patients consent after detailed information. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: •Duration of diabetes more than 10 years;•Serious chronic infection or during an acute infection which is currently active;•chronic granulomatous infections (e.g., a previous diagnosis of tuberculosis or a current diagnosis based on chest radiography or laboratory exam);•a history of recurrent infections or a predisposition to infection;•C-peptide <0.5 ng/mL (0.1665 nmol/L);•neutropenia (leukocyte count<2000/mm3) or anemia (hemoglobin level <11g/dl for men and less than 10 g/di for women;•presence of one or more contraindication of anakinra RCP;•presence of one or more contraindication of TNF ihibitor RCP; •presence of one or more contraindication to metrotrexate treatment;•previous heart attack or ischemia;•patients suffering from cardiac insufficiency: grade of NYHA severity III or IV;•Liver insufficiency/liver disease raised liver parameters (ALAT/ASAT);•Pregnancy or female patients with the ability to get pregnant, who do not use any efficacious method of contraception;•Lactation;•Participation in another clinical study util 6 month before enrollment;•Serious depression or other relevant psychiatric disease;•Serious renal injury, known malignancy;•Clinically significant history of alcohol or drug addiction may preclude the subject's participation in the study; in the judgment of the physician;•any condition that, in the opinion of the physician, precludes the possibility of using the study drug (anakinra, Kineret) or control drug (anti-TNF-alpha L04AB ATC) in accordance with the conditions of RCP;•any other condition or laboratory parameter that, in the opinion of the physician, precludes the subject's participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to assess if daily treatment with Anakinra in patients suffering from Rheumatoid arthritis and having diabetes mellitus as a comorbidity,together with the well-known effect in inducing RA remission has possible related therapeutic potential in the treatment of type 2 diabetes by controlling hemoglobin glycated;Secondary Objective: Evaluation of efficacy and safety in patients suffering from Rheumatoid arthritis and having diabetes mellitus as a comorbidity.;Primary end point(s): Change from baseline to 3 months, 6 months, 12 months and 24 months of HbA1c.;Timepoint(s) of evaluation of this end point: 3 months, 6 months, 12 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy signs and symptoms of AR to assess the change from baseline at 3 months, 6 months, 12 months and 24 months of treatment of: • Percentage of patients in remission (European League Against Rheumatism criteria - EULAR) based on the evaluation of the Disability Activity Score (DAS28) and the Simplified Disease Activity Index (ICSD); • Percentage of patients improved (EULAR criteria) based on the assessment of the DAS28 and the ICSD; • Count of tender joints (66 joints); • Count of swollen joints (68 joints); • Administration Health Assessment Questionnaire (HAQ). Laboratory parameters: to assess the change from baseline at 3 months, 6 months, 12 months and 24 months of treatment of: •plasma levels of CRP, ESR, •plasma level of glucose, •plasma levels of trygliceridis, total cholesterol, HDL, LDL •microalbuminuria to assess the change from baseline at 6 months, 12 months of treatment of : • anti-dsDNA antibody and antinuclear antibody (ANAs), to assess the change from baseline at 12 months of treatment of: anti citrulline antibody (anti CCP) and rheumatoid factor. Instrumental parameters: Echocardiographic findings: to assess at baseline, 6 months, 12 months and 24 months of treatment of: •left ventricular functional changes with TDI (Tissue Doppler Imaging) • changes (from baseline) of coronary blood flow by measurement of the aortic strain (Pulse Wave velocity technique) •left ventricular morphological changes by measurement of RWT (relative wall thickness) Other parameters: •Retina injury evaluation •BMI Safety • Assessment of the frequency and intensity of adverse events (AE) in accordance with procedures defined by the study protocol. • Evaluation of laboratory and instrumental parameters •Assessment of vital signs and physical examination. •Evaluation of hypoglycemic episodes;Timepoint(s) of evaluation of this end point: 3 mon | — |
Countries
Italy
Contacts
Public ContactSERVIZIO CRO PHARMA D&S
PHARMACEUTICAL DEVELOPMENT AND SERVICES
Outcome results
None listed