rheumatoid arthritis treatment after first anti-tnf investigation

Conditions: Rheumatoid Arthritis

Summary: to compare the efficacy of switching to a different molecular target (from tnf to il6) versus cycling to a second tnf inhibitor in patients with active ra, who have not adequately responded to a previous treatment with a first anti-tnf.

new drugs for the treatment of rheumatoid arthritis (ra) with action on specific molecular target (e.g. anti-tnf) have improved the prognosis of patients with an inadequate response to conventional therapy such as methotrexate (mtx). however, approximately 50% of patients treated with first-line anti-tnf discontinue treatment after two years due to ineffectiveness or adverse events. the second line treatment involves the use of another anti-tnf drug or switching to a different molecular target (anti-il6, -cd20 or ctla-4-ig) in combination with mtx.

Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of signing the informed consent form and either male or female. * diagnosis of ra according to the 1987 acr classification criteria or 2010 acr/eular classification criteria at least 6 months prior to screening. * patients with persistent ra disease activity whilst being treated with an initial tnfi agent on a background mtx up to 20-25 mg/week for at least 12 weeks defined according to sir and eular guidelines as: primary non-response: failing to improve das28 by ≥ 1.2 or failing to achieve das28 ≤ 3.2 within the first three to six months of starting the initial tnfi; secondary non-response: determined by physician decision with evidence of flare and deterioration in das28 of ≥ 1.2. * methotrexate (mtx) dose stable for 28 days prior to screening. * patients on nsaids and / or corticosteroids must remain on an unchanged regimen for at least 28 days prior to study drug administration. * the patient must be able to comply with the study visit schedule and other protocol requirements. * the patient understands the purpose of the study and is able and willing to sign the informed consent form, according to ich/gcp. * signed written informed consent for biological analysis. * female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. women of childbearing potential and male patients must be willing to practice acceptable methods of contraception during treatment and for 6 months (female patients) and 3 months (male patients) after discontinuation of treatment. exclusion criteria: * patients who have previously received more than 1 tnfi drug or any other biological therapy. * patients with inflammatory joint disease of different origin or any arthritis with onset prior to 16 years of age. * patients taking any disease-modifying antirheumatic drug (dmards) (e.g. all except methotrexate). discontinuation must occur at least 28 days prior to study treatment start. * history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug. * known hypersensitivity to any active substance or excipients of study drug. * pregnancy or breast feeding.

Keywords: rheumatoid arthritis tocilizumab anti-tnf treatment