CZP + Methotrexate in Early Active Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A multi-centre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of DMARD-naïve adults with early active Rheumatoid Arthritis

• IRAS ID

  92639

• Contact name

  Hasan Tahir

• Sponsor organisation

  UCB Pharma S.A

• Eudract number

  2011-001729-25

• Clinicaltrials.gov Identifier

  NCT01519791

• Research summary

  Rheumatoid arthritis (RA) is a long-lasting (chronic) inflammatory disease affecting many joints throughout the body, resulting in pain, swelling and joint damage with deformity which gets worse over time, causing loss of function and disability. Conventional therapies consist of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and disease-modifying anti-rheumatic drugs (DMARDs), all of which are associated with varying degrees of effectiveness. Over the past 10 years, the management of RA has seen radical changes, including the introduction of multiple new biological DMARDs, such as anti-tumour necrosis factor-inhibitors (anti-TNFs) which work to restrict the body??s inflammatory response. Anti-TNF treatments have been shown to be effective and dramatically improved the outcomes for patients with RA and the use of biologics has been shown to reduce structural damage of joints. There is vast evidence that the earlier the treatment and the resulting reduction in joint damage, the better the long-term outcomes. It has been reported that joint erosion may occur as early as 6 months from the onset of RA and that damage can occur rapidly during the first 2 years. UCB Pharma S.A. have developed an anti-TNF drug (Cimzia©) that is approved for the treatment of moderate to severe active RA in the EU, US and other countries. This research study is being done to see if the drug is effective and safe for use in patients with early active RA and if it can help patients to go into remission, with no or few disease symptoms. This is a randomised, placebo-controlled study, during which all patients will receive Methotrexate (an approved treatment for RA) in addition to study drug or placebo.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0117

• Date of REC Opinion

  1 Jun 2012

• REC opinion

  Further Information Favourable Opinion