A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis

Merck Serono International0 个研究点目标入组 0 人开始时间: 2008年2月7日最近更新: 2021年10月8日

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•The trial will enrol male and female subjects ³18 years of age at the time of Informed Consent who have rheumatoid arthritis satisfying American College of Rheumatology criteria and a disease history of at least 12 months. Subjects must have active disease; defined by ³8 swollen joints (out of 66), ³8 tender joints (out of 68) and CRP ³6 mg/L or ESR ³28 mm/h. Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab: i.e. they must have a documented response after an observation period of at least 16 weeks from initiation of treatment to a previous course of rituximab treatment given at least 24 weeks before SD1 and they must have significant residual active disease after previous rituximab treatment or clinical deterioration after initial response (defined by satisfying the above criteria for active disease).Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four weeks before SD1, during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and at SD1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Main exclusion criteria are:
•· Neurological disease.
•· Inflammatory joint disease other than RA.
•· Any contraindication to rituximab as per national label.
•· Known presence of human anti-chimeric antibodies (HACA) to rituximab.
•· Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week.
•· Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer).
•· Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1.
•· Active or latent tuberculosis within the year before screening or major infection requiring hospitalisation or intravenous anti-infectives within 28 days before SD1.
•· Serum IgG below 6 g/L.
•· Known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
•· Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins.
•· Breastfeeding or pregnancy.

发起方

Merck Serono International