Status:
TERMINATED
Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes
Lead Sponsor:
Prof. Roberto Giacomelli
Conditions:
Diabetes Mellitus, Type 2
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The TRACK \[Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)\]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycat...
Eligibility Criteria
Inclusion
- male and female patients aged ≥ 18 years;
- previous diagnosis of RA with criteria of the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR);
- Diagnosis of Diabetes Mellitus type II according to the American Diabetes Association (ADA) criteria since at least 6 months;
- Patients with an inadequate response to previous treatment with methotrexate (determined on the basis of the evaluation of the physician);
- BMI \<35
- Glycated hemoglobin \> 7% \<10%
- Minimum score Disease Activity Score-28 (DAS 28) \> 3.2
- For patients previously treated with a biologic drug, wash out of the treatment for at least 1 month prior to enrollment;
- For patients in treatment with hypoglycemic drugs at enrollment, no change of the hypoglycemic treatment in terms of type of drug and dosage, for a period of at least 3 months before enrolment
- For patients in therapy with other drugs at baseline, no change in terms of drug administered and the dosage regimen for a period of at least 1 month prior to enrollment;
- Absence of signs and symptoms related to ischemic heart disease
- Signature of written Informed Consent Form.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02236481
Start Date
July 1 2013
End Date
December 1 2017
Last Update
December 14 2018
Active Locations (1)
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1
L'Aquila University
L’Aquila, Italy, 67100