A Phase I, randomised, double-blind, placebo-controlled, single centre, multiple-dose ranging study to investigate the safety, tolerability, and pharmacodynamics of subcutaneously administered DEN-181 in adult patients with ACPA+ rheumatoid arthritis on stable treatment with methotrexate.

Dendright Pty Ltd0 个研究点目标入组 40 人开始时间: 2017年10月18日最近更新: 2022年9月26日

适应症

试验速览

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•Diagnosis of RA made by a rheumatologist;
•HLA-DRB1*0401+, HLA-DRB1*0101+ or HLA-DRB1*0401+HLADRB1*0101+ heterozygotes, homozygotes or compound heterozygotes and ACPA+;
•Treatment with MTX at the same dose for at least 4 weeks prior to planned start of trial treatment;
•Age 18-75 years, inclusive;
•Male or female. Females of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study;
•Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines;
•Blood glucose, CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT not greater than 1.5 x out of normal laboratory ranges at entry and clinically insignificant in opinion of investigator;
•Patients agree to forego vaccinations during the course of the study.

•Malignancy;
•An active inflammatory disease other than RA;
•Currently receiving or have received treatment with >10mg prednisone daily within the last 2 weeks prior to screening;
•Current or recent treatment (< 2 weeks prior) with any diseasemodifying anti-rheumatic drugs (DMARDS) other than MTX;
•Serious infection requiring hospitalisation within last 28 days;
•Receipt of any live attenuated vaccines within 4 weeks prior to entry;
•Major surgery within last 28 days;
•Significant cardiovascular, renal, liver, neurological or skin disease;
•Positive serology for HIV, or infection with HBV or HCV;
•Current treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, PUVA, acitretin cyclosporine or azathioprine;
•Any known or suspected allergies to the study drug or its constituents including egg products;
•Inadequate venous access to allow collection of blood samples;
•History of drug or alcohol abuse;
•Participation in any other clinical trial;
•If, in the opinion of the PI, the subject appears not to be able to perform the needed responsibilities of participation in the clinical study.

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