AB0712 Eligibility of patients with giant cell arteritis for entry into a prospective randomised controlled trial: a single-centre experience
Authors: W.A. Schmidt, K. Hofheinz, S. Burger, V.S. Schäfer, A. Juche
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> The interest in pharmaceutical trials in giant cell arteritis (GCA) is increasing. Trial recruitment may be more challenging in GCA than in other rheumatic diseases because of a higher proportion of elderly patients who are additionally faced with a new diagnosis when being considered for trial participation. <h3>Objectives</h3> To analyse the eligibility of newly diagnosed and flaring GCA patients in one centre for randomization in the SIRRESTA trial (ClinicalTrials.gov Identifier, NCT02531633; sirukumab versus placebo), to list reasons for non-randomization, and to compare eligible with non-eligible patients. <h3>Methods</h3> All patients with newly diagnosed or relapsing GCA considered for trial participation between August 2016 until trial termination in October 2017 were included. The trial was prematurely terminated by the sponsor based on the decision to discontinue development of sirukumab in autoimmune diseases. Analysis of variance, two-sided Fisher's exact and Pearson's chi-squared tests were applied for calculating statistical significance. <h3>Results</h3> Ninety-five patients were pre-screened. Fifteen of these patients were screened and only 12 of the 95 (13%) pre-screened GCA patients were eligible for randomization based on inclusion and exclusion criteria. The other 83 patients were not eligible for one or more of the following reasons: Concomitant diseases (42%) including second autoimmune disease (11%), malignancy (6%), history of diverticulitis (5%), hepatopathy (2%), renal insufficiency (1%) frailty (6%) and dementia (2%), ischaemic disease (2%; 1 myocardial infarction and 1 severe tongue necrosis), abnormal or inconclusive tests for tuberculosis (5%) and hepatitis (1%); failure to meet inclusion criteria (41%), including symptoms (12%), histology/imaging (1%), exceedance of maximum glucocorticoid dose (7%), too low ESR and CRP (10%), too long treatment duration (11%); declined consent (29%), before (11%) and after receiving the consent form (18%); too long distance to study centre (5%). Patients eligible for the trial were younger. They had no ischaemic complications (see table 1). A higher proportion of relapsing GCA patients were included. This subgroup of a larger trial represents only data from one centre. It may not be representative for the findings in other centres or the whole study. <h3>Conclusions</h3> Many newly diagnosed or relapsing GCA patients were not eligible for a trial due to concomitant diseases, failing inclusion criteria or declined consent. Eligible patients were younger; and more had relapsing disease. <h3>Disclosure of Interest</h3> W. Schmidt Grant/research support from: Roche, GSK (principle investigator), Consultant for: Roche, GSK, Sanofi, Speakers bureau: Roche, K. Hofheinz: None declared, S. Burger Grant/research support from: GSK (sub-investigator), V. Schäfer Grant/research support from: GSK (sub-investigator), A. Juche Grant/research support from: GSK (sub-investigator)