Dose Ranging Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate
The purpose of this clinical trial is to assess the safety, efficacy, tolerability, immunogenicity and pharmacokinetics of 3 dose levels of ART621 in the treatment of rheumatoid arthritis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Multi-Centre Randomised Double-Blind Pbo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability, Efficacy, PK and Immunogenicity of Multiple Doses of ART621 for 3 Months in Patients With Rheumatoid Arthritis Taking Methotrexate|
- Efficacy of ART621 on the signs and symptoms of moderate to severe RA in subjects concomitantly taking methotrexate as assessed by the proportion of subjects achieving an ACR20 response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Dose-response relationship of ART621 against the signs and symptoms of moderate to severe RA as assessed by additional efficacy, safety and QoL parameters. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Immunogenicity profile of ART621 as assessed by development of HAHAs. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Plasma concentration versus time profile and population PK of ART621 in subjects with RA. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Effect of ART621 on immunological parameters and other disease biomarkers. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: ART621 A
ART621 0.75mg/kg per week
Experimental: ART621 B
ART621 1.5 mg/kg per week
Experimental: ART621 C
ART621 3.0mg/kg per week
|Placebo Comparator: Placebo arm||
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 assess the safety, efficacy, tolerability, immunogenicity and pharmacokinetics of ART621 when administered with an intravenous loading dose followed by subcutaneous administration every week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928317
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