Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC)
Research type
Research Study
Full title
STopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
IRAS ID
245233
Contact name
Gordon Moran
Contact email
Sponsor organisation
Robarts Clinical Trials Inc.
Eudract number
2018-001382-17
ISRCTN Number
ISRCTN11111111
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2018-001382-17, EurdaCT
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD.
In this open-label (where both the researchers and participants know which treatment is being administered), randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24-month period.
There will be a 2 year follow up period to see if participants develop any flares or complications of their CD, to monitor their quality of life and assess the impact on the cost associated with their assigned treatment. The results of the study may help to improve evidence based treatment guidelines and the approach to patient care.
Participants will be randomly assigned by a computer to one of two groups:
1. Group 1: Continuation of 5-ASA treatment
2. Group 2: Discontinuation of 5-ASA treatment
At the end of the study, half of the participants will be in Group 1 and half of the participants in Group 2. After participants have been assigned to one of these two study groups, they will continue in that group for the duration of their time in the study.
Approximately 1580 participants will be taking part in this study.
Participants will be asked to attend hospital visits for a total of 5 times over a two-year period, where they will undergo the following procedures at most or all study visits: Blood taking, Physical Exam(only at first visit), vital signs, medication review, side effects review, urine sample, questionnaires and stool samples.REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0119
Date of REC Opinion
10 Oct 2018
REC opinion
Favourable Opinion