Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.

OSSERVATORIO EPIDEMIOLOGICO GISEA0 个研究点开始时间: 2012年7月25日最近更新: 2013年1月7日

适应症

试验速览

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•1) Written Informed Consent; 2) Patients aged 18-75 years; 3) RA classified using the 2010 ACR/EULAR criteria; 4) Patients who have had to interrupt a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and / or patients who have not responded adequately to a combination of a first-line combination of DMARD / biological treatment; 5) Patients in whom it is indicated starting a treatment with an inhibitor of IL-6R, for values ??indicative of high systemic inflammation (ESR = 28 mm/h, PCR> 5 mg/l, Fibrinogen> 400 mg/dl and / or albumin <3.5 g/dl)and high disease activity (DAS> 2.4), or contraindications to the use of DMARDs that should take a biologic drug monotherapy;6) Treatment with corticosteroids at a stable dose (=7.5 mg) for at least 4 weeks; 7) Joint symptoms for at least three but no more than 24 months from the screening visit (early RA); 8) DAS44 >2.4 and/or SDAI >11 (moderate or high activity); 9) Patients able to comply with the procedures and timing of the study.
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1) Ongoing pregnancy or lactation; 2) Severe active infections; 3) Patients with other clinically significant concomitant diseases, whose treatment and outcome are able to interfere with the evaluation required by the study protocol; 4) Blood AST or ALT > 1.5 times the upper normal limit; 5) ANC count < 2 x 103/µl; 6) Platelet count < 100 x 103/µl; 7) Patients with other autoimmune rheumatic diseases in addition to the RA (eg,systemic lupus erythematosus [SLE], scleroderma, polymyositis, etc ...); 8) Clinical history or presence of other concomitant inflammatory diseases in addition to RA ( tophaceous gout, reactive arthritis, psoriatic arthritis, etc. ...).

发起方

OSSERVATORIO EPIDEMIOLOGICO GISEA