Study of Efficacy & Safety of Adalimumab in Axial Spondyloarthritis

• Research type

  Research Study

• Full title

  A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Axial Spondyloarthritis

• IRAS ID

  24495

• Sponsor organisation

  Abbott GmbH & Co. KG

• Eudract number

  2009-010643-14

• ISRCTN Number

  n/a

• Research summary

  Axial spondyloarthritis (SpA) is an inflammatory arthritic condition that predominantly affects the spine. Traditional anti-rheumatic therapies are not effective treatments for axial SpA with the exception of 'Non Steroid Anti Inflammatory Drug' (NSAIDs). This study will be looking at Axial SpA patients with inadequate response or intolerance to NSAIDs. Adalimumab is a recombinant human immunoglobulin (IgG1) monoclonal antibody. Adalimumab binds to TNF-a, TNF is naturally occurring and is involved in normal inflammatory and immune responses (how your body reacts to deal with infections and injuries). Elevated levels of TNF play an important role in pathologic inflammation. Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with TNF receptors. Adalimumab modulates biological responses that are induced or regulated by TNF. After treatment with adalimumab, acute inflammation can rapidly decrease. The objective of this study is to evaluate the effectiveness and safety of adalimumab at a dose of 40 mg, given every other week as an injection, for the treatment of axial SpA. Adalimumab will be given to patients with active axial SpA and will be compared against placebo (in the form of an injection that contains no active drug) for 12 weeks. After 12 weeks all patients will be treated with adalimumab and assessed for safety and effectiveness for an additional 92 weeks. Patients completing the full 104 weeks in the study will be required to attend 19 clinic visits. Eligible patients have active axial SpA and have had an inadequate response to, or intolerance to one or more NSAIDs.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/102

• Date of REC Opinion

  13 Oct 2009

• REC opinion

  Further Information Favourable Opinion