OPTIMISE Study

More information
Status: 
Starting date: 
September, 2020

Is there a better way to optimise disease control for patients with ulcerative colitis? A new study aims to find out

Achieving and maintaining effective control of ulcerative colitis is the goal of treatment, but, as all patients know, it can be a challenge.  Current management of mild-to-moderate ulcerative colitis is typically guided by symptoms, with therapy increased during a flare and decreased when controlled.

 This can be considered quite reactive and may result in patients quickly moving through increasingly strong therapy options, such as steroids and biologics, which can potentially have serious side effects, to combat a disease flare. 

The arrival of new, easier ways for patients to accurately measure their disease activity, such as measuring faecal calprotectin levels, has the potential to better guide treatment optimisation and achieve better outcomes. A new international study called OPTIMISE (clinicaltrials.gov NCT043340895), organized by Ferring, aims to find out if a more proactive approach to management does indeed improve disease control and patients’ lives.

The OPTIMISE study has a practical (pragmatic) design and will compare two management approaches in patients with active mild-to-moderate ulcerative colitis who are currently receiving either no treatment regimen or mesalazine (5-aminosalicylates, 5-ASA):

  1. Current management – treatment decisions based on symptoms.
  2. Proactive management – treatment decisions based on faecal calprotectin levels and symptoms. 

The proactive management approach has a number of potential advantages over current management: 

  • Increased patient involvement in management of their disease
    •  Home monitoring of faecal calprotectin

·       Earlier treatment decisions

·       Improved use of mesalazine treatment and use of locally acting steroids with few side effects

·       Avoid use of (systemic, wide acting) steroids and biologics when not needed

o   Reduced side effects for patients

o   Money savings on biologics for the health care system

·       Avoid endoscopies/colonoscopies by monitoring faecal calprotectin

·       Longer-term disease control (remission) by basing treatment decisions on actual disease activity, rather than just on symptoms

·       Help doctors to manage their patients better by providing simple information on when best to increase and decrease treatment

 

The study duration for each patient will be 1 year and involve around 240 patients from 30-50 hospitals and is recruiting currently in 3 countries (Poland, Czech Republic and Netherlands) and looking to expand to other countries.  If you have active ulcerative colitis and are currently receiving no treatment or mesalazine treatment and live in one of the study countries, please contact your doctor / IBD service about potentially being involved in the OPTIMISE study.

Increased, proactive involvement by patients in monitoring their disease activity

may offer a better way to help optimise treatment for ulcerative colitis