Certolizumab Pegol (CZP) in Active Axial Spondyloarthritis (SpA)

• Research type

  Research Study

• Full title

  Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in subjects with active axial spondyloarthritis (Axial SpA) Protocol Number AS001

• IRAS ID

  37601

• Contact name

  Paul Emery

• Sponsor organisation

  UCB BIOSCIENCES, GmbH/UCB BioSciences Inc.

• Eudract number

  2009-011719-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to determine if the Certolizumab Pegol, a TNFa-antagonist (Cimzia©), is a safe and suitable treatment for patients with active axial spondyloarthritis (SpA). Axial SpA is the name given to a group of chronic or long-lasting diseases that affect the spine and the sacroiliac joints (where the spine meets the pelvis), which may lead to fusion of the spine. The most well acknowledged subset of the axial SpAs is ankylosing spondylitis (AS). About 1 in 1000 people in the UK develop AS at some point in their life. Those in their 20s and 30s are affected most often. Men are two to three times more likely than women to have spondyloarthritis. Conventional treatment of AS has included nonsteroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. NSAIDs reduce inflammation and ease the pain, but sometimes have unacceptable side effects, especially in the gastrointestinal tract. The introduction of TNF-antagonists represents a major advance in the drug treatment of AS, and preliminary data support their efficacy in axial SpA. Currently there is no approved treatment for patients with axial SpA. Early data support that TNF-antagonists may work as well if not better for treatment of all axial SpA rather than just AS only. The therapeutic response to currently available TNF-antagonists is variable in AS. This is also true for tolerability and is in keeping with the well known idiosyncratic response to traditional disease-modifying antirheumatic drug (DMARDs). Therefore, there remains a medical need for additional effective TNF-antagonists for the treatment of AS, and an approved treatment for axial SpA. Thus, the benefit this study is the potential efficacy and future availability of a new TNF-antagonist treatment for axial SpA, which includes those diagnosed with AS. For each subject, the study will last a maximum of 171 weeks, and approximately 315 subjects across 100 sites worldwide will take part in this research.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/13

• Date of REC Opinion

  13 May 2010

• REC opinion

  Further Information Favourable Opinion