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Clinical Trial Details

Trial ID: L3991
Source ID: NCT02236481
Associated Drug: Anakinra
Title: Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes
Acronym: TRACK
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Arthritis, Rheumatoid
Interventions: DRUG: Anakinra|DRUG: TNF alpha inhibitors
Outcome Measures: Primary: Glycated Hemoglobin, up to 24th months of treatment | Secondary: Percentage of patients in remission ( EULAR Criteria ), baseline , after 3 months, 6 months , 12 months and 24 months of treatment|Percentage of patients improved ( EULAR criteria), baseline , after 3 months, 6 months , 12 months and 24 months of treatment|Count of tender joints (66 joints), baseline , after 3 months, 6 months , 12 months and 24 months of treatment|Count of swollen joints (68 joints), baseline , after 3 months, 6 months , 12 months and 24 months of treatment|Administration at Health Assessment Questionnaire ( HAQ), baseline , after 3 months, 6 months , 12 months and 24 months of treatment|C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR ), baseline , after 3 months, 6 months , 12 months and 24 months of treatment:|Plasma levels of glucose, baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Sponsor/Collaborators: Sponsor: Prof. Roberto Giacomelli
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-07
Completion Date: 2017-12
Results First Posted:
Last Update Posted: 2018-12-14
Locations: L'Aquila University, L'Aquila, 67100, Italy
URL: https://clinicaltrials.gov/show/NCT02236481