A Phase I, randomised, double-blind, placebo-controlled, single centre, single-dose escalation 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 17 人开始时间: 2017年10月19日最近更新: 2022年9月12日

适应症

试验速览

暂无简介。

•The criteria for entry into the study are:
•1. Diagnosis of rheumatoid arthritis made by a rheumatologist;
•2. HLA-DRB1*0401+, HLA-DRB1*0101+ or HLA-DRB1*0401+HLA-DRB1*0101+ heterozygotes, homozygotes or compound heterozygotes; and ACPA+ (anti-CCP2>6);
•3. Treatment with MTX at the same dose for at least 4 weeks prior to planned start of trial treatment;
•4. Age 18-75 years (male or female) inclusive;
•5. Patients must be informed of the investigational nature of this study and give voluntary written informed consent in accordance with the institutional and hospital guidelines;
•6. With or without swollen joints;
•7. Male or Female. Females of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study;
•8. Blood glucose, CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT not greater than 1.5 times out of normal range at entry and clinically insignificant in the opinion of the investigator;
•9. Patients agree to forego vaccinations during the course of the study;

•The criteria for exclusion from the study are:
•1. Malignancy;
•2. An active inflammatory disease other than RA;
•3. Currently receiving or have received treatment with >10mg prednisone daily within the last 2 weeks prior to screening;
•4. Current or recent treatment (< 2 weeks prior) with any disease-modifying anti- rheumatic drugs other than methotrexate;
•5. Serious infection requiring hospitalization within last 28 days;
•6. Receipt of any live attenuated vaccines within 4 weeks prior to entry;
•7. Major surgery within last 28 days;
•8. Significant cardiovascular, renal, liver, neurological or skin disease;
•9. Positive serology for HIV or infection with HBV or HCV;
•10. Treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, PUVA, acitretin, cyclosporine or azathioprine;
•11. Any known or suspected allergies to the study drug or its constituents including egg products;
•12. Inadequate venous access to allow collection of blood samples;
•13. History of drug or alcohol abuse;
•14. Participation in another clinical study;
•15. 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.

发起方