CZP + MTX vs. ADA + MTX in Moderate to Severe RA

• Research type

  Research Study

• Full title

  A Multicentre, Single-Blind, Randomised Parallel-Group Study to Assess the Short and Long-Term Efficacy of Certolizumab Pegol plus Methotrexate Compared with Adalimumab plus Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

• IRAS ID

  100141

• Contact name

  Hasan Tahir

• Sponsor organisation

  UCB Pharma S.A.

• Eudract number

  2011-002067-20

• Clinicaltrials.gov Identifier

  NCT01500278

• Research summary

  Rheumatoid arthritis (RA) is a continual inflammatory disease affecting one or many joints throughout the body, resulting in pain, swelling and joint damage which can result in deformity which gets worse over time. These deformities can cause loss of function and disability. Current research suggests that better long-term outcome in patients with RA can be seen when the treatment results in early remission. Meaning minimal signs and symptoms or low disease activity. A protein produced by cells in the immune system plays a role in helping to cause inflammation in diseases like RA; this substance is called tumour necrosis factor (TNF)-alpha. Treatments that work against TNF called Anti-TNF drugs. These have been shown to be effective in improving the symptoms and disease of patients with RA. UCB Pharma S.A. has developed an anti-TNF drug (Cimzia©) that is approved for the treatment of patients with moderate to severe active RA in the EU, US and other countries. UCB Pharma S.A.is doing this study to compare Cimzia© with another approved anti-TNF drug called Humira to see how patients with moderate to severe RA, do in the first 12 weeks of treatment and then over 2 years. The study patient will be those who are not doing well with methotrexate alone (an approved standard first treatment for patients with RA). This is a study, during which all patients will receive methotrexate in addition to one of the two study drugs. Patients who have not responded to the one study treatment by week 12 will be switched over to the other study treatment. Any patients who are still not doing well even after being switch to the other treatment by week 24, regardless of which group they are assigned, will be withdrawn from the study and offered another approved treatment after further evaluation from their doctor.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  12/NE/0198

• Date of REC Opinion

  23 Jul 2012

• REC opinion

  Further Information Favourable Opinion