MAD / POC Study of ATN-103 in Subjects with Active RA
Research type
Research Study
Full title
A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects with Active Rheumatoid Arthritis on a Background of Methotrexate
IRAS ID
28631
Contact name
Karen Douglas
Sponsor organisation
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eudract number
2008-007185-33
Clinicaltrials.gov Identifier
Research summary
This research study will involve subjects with rheumatoid arthritis (RA). This is a potentially disabling condition which results in inflammation within joints and surrounding bone and which affects approximately 1% of the population. Conventional treatment for this condition includes disease modifying antirheumatic drugs (DMARDs) (e.g. methotrexate (MTX), fluomide, and sulfasalazine) however patients showing resistance to these drugs have shown to benefit from alternative biologic therapies such as tumour necrosis factor inhibitor (TNFi) agents. ATN-103 is a novel, highly potent TNFi agent with a half life longer than that of currently marketed TNFi agents. The main purpose of this study is to assess the safety and efficacy of multiple ascending doses of ATN-103 administered subcutaneously (SC) to subjects with active RA compared with placebo. During the multiple ascending dose (MAD) component of the study, each subject will be randomly assigned to only one of six treatment groups and will receive a subcutaneous (SC) injection of a single dose level of ATN-103 or placebo every 4 weeks for a total of 4 SC injections. During the proof of concept (POC) component, allocation will switch from sequential to parallel, and additional subjects will be randomly assigned in equal allocation ratios to all tolerated ATN-103 treatment groups and placebo. Safety, pharmacokinetic (PK) (what the body does to the drug) and quality of life data will be obtained, and markers of efficacy will be assessed. Safety parameters assessed will include adverse events reported, physical examinations, vital signs, immunogenicity assessments (measurement of anti-ATN-103 antibodies) and laboratory evaluations. Subjects will sign an informed consent form before any tests or examinations are done and before any questions are asked. Each subject??s suitability for the study will be assessed during a screening visit. The treatment period is up to 16 weeks. Subjects who permanently discontinue study medication will be followed up.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
09/H1208/63
Date of REC Opinion
26 Nov 2009
REC opinion
Favourable Opinion