Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Safety and tolerability of subcutaneous injections of ART621 (preceded by a single i.v. loading dose) at different dose frequencies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
3.0mg/kg s.c. - weekly
3.0mg/kg s.c. - fortnightly
1.5mg/kg s.c. - weekly
1.5mg/kg s.c. - fortnightly
|Placebo Comparator: 5||
Placebo s.c. - weekly
|Placebo Comparator: 6||
Placebo s.c. - fortnightly
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.