CCP - Next Generation

• Research type

  Research Study

• Full title

  CCP - Next Generation: Co-ordinated Programme to Prevent Arthritis - A study to Identify Arthritis at a Pre-Clinical Stage.

• IRAS ID

  213744

• Contact name

  Paul Emery

• Sponsor organisation

  The University of Leeds

• Duration of Study in the UK

  4 years, 9 months, 31 days

• Research summary

  The primary objective for part 1 of this study is to determine the proportion of community patients with new-onset, non-specific musculoskeletal complaints who are anti-CCP Ab positive. It is recognised that patients with inflammatory arthritis (IA) often have non-specific musculoskeletal complaints in the months or years prior to the development of RA (National Audit Office, 2009). Family members of individuals with IA are also at greater risk of developing IA.

  In part 2 of the study, the primary objective is to determine the number of anti-CCP Ab positive patients who develop IA by 48 weeks / after 48 weeks.

  By employing a risk stratification model, we aim to identify a cohort of individuals at high risk of developing IA who may be appropriate for interventional research (including CTIMPs) aimed at preventing progression to IA. Designs of such interventional research include Trials within Cohorts (TwiCs).

  For the part 2 of the main study, there are various types of control subjects that might participate. Eligible healthy subjects, RF positive patients, FDRs and RA patients are invited to attend for a baseline visit. In addition, those RF positive patients are invited to attend additional visits. The data collected for the control subjects will be compared with data collected for the anti-CCP Ab positive patients.

  The biological sub-study used to test various scientific hypotheses which include investigation on disease biomarkers and functional studies. The mucosal site sub-study will study samples collected at various mucosal sites to find out possible interactions between the host and the environment that can lead to initiating IA. The sites being studied include the periodontal, lung and gut regions.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  17/YH/0177

• Date of REC Opinion

  21 Jul 2017

• REC opinion

  Further Information Favourable Opinion