Certolizumab Pegol (CZP) in Active Psoriatic Arthritis (PsA)

• Research type

  Research Study

• Full title

  PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ADULT ONSET ACTIVE AND PROGRESSIVE PSORIATIC ARTHRITIS (PSA)

• IRAS ID

  38976

• Contact name

  Paul Emery

• Sponsor organisation

  UCB BIOSCIENCES, GmbH/UCB BioSciences Inc.

• Eudract number

  2009-011720-59

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL (CIMZIA©) IN SUBJECTS WITH ADULT-ONSET PSORIATIC ARTHRITIS This study aims to determine if Certolizumab Pegol, a TNFa-antagonist (Cimzia©), is a safe and suitable treatment for patients with adult-onset Psoriatic Arthritis (PsA). Psoriasis is a long-term (chronic) scaling disease of the skin, which affects 2% ?? 3% of the UK population. It appears as red, raised scaly patches known as plaques. Plaques most commonly appear on the elbows, knees and scalp. It can be itchy, but is not usually painful. 10% to 20% of people will develop psoriatic arthritis. More than 50% of patients with PsA experience progressive, erosive arthritis, accompanied with pain, fatigue and functional impairment. The combination of both joint and skin symptoms of PsA can have a profound impact on a patient's function, well-being and quality of life. Therapeutic approaches for PsA have focused on a similar etiology underlying both Rheumatoid Arthritis (RA) and PsA and treatment for PsA has traditionally included nonsteroidal anti-inflammatory drugs (NSAIDs) and data support their efficacy in the treatment of peripheral arthritis. The TNFa-antagonists (there are 4 registered in Europe for PsA) have improved the signs and symptoms of peripheral arthritis in PsA and accompanying psoriatic skin disease. In addition, all have demonstrated improvement in functional status and patient quality of life as well as showing diminished progression of joint damage on X-ray. However, for reasons of loss or lack of efficacy or intolerance to these currently available TNFa-antagonists, there remains a need for additional TNFa-antagonists as therapeutic options for patients with PsA, as observational data support that failure of an initial TNFa-antagonist does not prevent the response to another one. For each subject, the study will last a maximum of 171 weeks, and approximately 390 subjects across 100 sites worldwide will take part in this research.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/14

• Date of REC Opinion

  13 May 2010

• REC opinion

  Further Information Favourable Opinion