Rheumatoid Arthritis Clinical Trial
Official title:
A Factorial-design, Randomised, Double-blind, Placebo-controlled, Dose Optimisation Study to Investigate the Safety, Efficacy, Immunogenicity and Pharmacokinetics of ART621 Following Multiple Dose Administration in Subjects Diagnosed With Rheumatoid Arthritis Concomitantly Taking Methotrexate
The purpose of this clinical trial is to establish what dose level and dosing frequency is optimal in the treatment of rheumatoid arthritis patients with ART621.
Despite being effective in approximately 60% of subjects, there are limitations to existing
anti-TNF therapies especially in relation to immunogenicity, safety and administration. In
addition, due to their high molecular weight, currently marketed products are largely
confined to the blood stream.
ART621 is an anti-TNF molecule that contains 2 identical domain "antibodies" that have the
binding activity of a full antibody but with a substantially smaller molecular size. The
molecular weight of approximately half that of full size antibodies is predicted to, a) have
improved tissue penetration and, b) to be less immunogenic than full size antibodies.
This clinical trial is designed to establish the optimal dose level and dose frequency of
ART621 in the treatment of patients with rheumatoid arthritis and to obtain data relating to
the safety, immunogenicity and pharmacokinetics of ART621 when administered with an
intravenous loading dose followed by subcutaneous administration every week compared to
every fortnight.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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