Dear Colleague,

We would like to invite you to participate in a new clinical trial: “STATIC – STopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial”. This is a fully funded study undertaken through a collaboration between the NIHR Nottingham Biomedical Research Centre and Robarts Clinical trials.

Substantial evidence indicates that 5-ASAs are one of the most commonly prescribed class of drug for patients with CD, despite evidence from randomized trials indicating uncertainty in their efficacy. Cumulative use leads to substantial healthcare costs. Furthermore, prescribing potentially ineffective therapies is likely to delay in initiation of effective treatments and result in preventable disease-related complications. A large, randomized, withdrawal trial of 5-ASA in CD would provide sufficient evidence to inform the practice of using 5-ASA as a maintenance therapy for the management of CD. The results of this study have the potential to change physician prescribing practices as well as reduce health care costs.

STATIC is pragmatic, open-label, randomized, non-inferiority trial, in which CD patients in remission will be randomized to either continue 5-ASA therapy or withdraw treatment. The primary objective of the trial is to determine whether withdrawal of 5-ASAs is non-inferior to continuation of these agents in Crohn’s disease (CD). The primary endpoint of the trial is highly clinically meaningful, namely occurrence of any CD-related complication (surgery, hospitalization, or other complication) within 24 months after enrollment.

The study involves a screening and enrolment visit, then follow up visits at 6, 12 and 24 months. Each follow up visit involves collection of a urine and stool sample, local labs and questionnaire completion. There is no requirement for colonoscopy. Study visits mirror NHS standard care as much as possible to make this study easily manageable by both investigators and patients.

The study has to date received peer reviewed, non-industry funding in Canada and the UK. STATIC has received REC and HRA approval and is adopted on the NIHR CRN non-commercial portfolio. We have started recruiting in the UK in April 2019.

We have invited you to participate in the STATIC trial because we believe you and your colleagues at your institution would be invaluable to ensuring the success of this trial to answer an important clinical practice question. Please let us know if you would be interested in being a study site and we would be happy to forward a study synopsis. Please contact us if you have further questions or if you would like to discuss this project further.

 

Sincerely,

Gordon Moran                                                                                                                                                                                            Vipul Jairath

STATIC UK Chief Investigator                                                                                                                                               STATIC Chief Investigator

Gordon.Moran@nottingham.ac.uk


Contacts:

Lee Anne Williamson

Trial Manager

leeanne.williamson@robartsinc.com
 

Natalie Horsepool

UK Trial administrator

Natalie.horsepool@nottingham.ac.uk