Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate
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|ClinicalTrials.gov Identifier: NCT00854685|
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : January 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: ART621 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
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
- Safety and tolerability of subcutaneous injections of ART621 (preceded by a single i.v. loading dose) at different dose frequencies [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854685
|Departement of Rheumatology, National Hospital Sri Lanka|
|Colombo, Sri Lanka|