None listed
Conditions
Brief summary
Observational multicentre cohort study on the long term outcomes of ulcerative colitis patients on ustekimumab therapy (post UNIFI study, NCT02407236), including time to flare, need for escalation and co-therapy for disease control. Time on treatment will be assessed from the first dose of ustekinumab, and 'survival' analysis performed with time on medication (with resutls censored at any loss to follow up. The primary outcome is proportion of patients who relapsed on ustekinumab, defined as a recurrence of flare/colitis symptoms with commensurate biochemical, endoscopic, histological, and/or radiological evidence of disease activity that led to commencement or dose escalation of medical therapy
Interventions
Non-interventional questionnaire on the long term outcomes of ulcerative colitis patients on ustekimumab therapy. Patients are not contacted. Instead questionnaires to be distributed to the clinical trials site to determine how many patients are on the compassionate access for ustekinumab and their clinical well being.
The questionnaire will be undertaken by a site trial coordinator from the clinical trials unit from the relevant institution (hospital). These will be taken either as face-to-fac
Non-interventional questionnaire on the long term outcomes of ulcerative colitis patients on ustekimumab therapy. Patients are not contacted. Instead questionnaires to be distributed to the clinical trials site to determine how many patients are on the compassionate access for ustekinumab and their clinical well being. The questionnaire will be undertaken by a site trial coordinator from the clinical trials unit from the relevant institution (hospital). These will be taken either as face-to-face or telephone consultations at the election of the site trial coordinator. The interview itself is expected to take up to 20 minutes, and will be corroborated from the clinical notes. This will be at a single time-point, and the date of this interview will be collected to determine the follow up time since enrolment in the UNIFI trial (and thus the duration they have been receiving the medication, ustekinumab). All information will be collected retrospectively, though some of the clinical information from hospital records will have been entered prospectively. The information collected will be: demographics, baseline clinical and endoscopic severity, clinical and endoscopic severity at the end of the induction and the maintenance study, clinical relapse data, biochemical (C-reactive protein and faecal calprotectin)/endoscopic severity (total and partial Mayo score) /radiologic (computerised tomography, magnetic resonance imaging, ultrasound) since enrollment in the UNIFI trial. Furthermore all possible adverse events will be reported via interview with the patient, but also with review of the clinical notes. The above information is necessary to determine: the types of patients described, the baseline severity and initial response to ustekinumab in the cohort, as well as the subsequent efficacy and adverse event rate in the cohort on this medication. This will be assessed at time that the trial coordinators are able to contact the consented patient, between July to December 2022
Sponsors
Concord Repatriation General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who participated in the UNIFI study (NCT02407236 , DOI: 10.1056/NEJMoa1900750) from Australian sites, and who persisted on ustekimumab therapy as maintenance treatment for their ulcerative colitis
Exclusion criteria
Patients with no relevant data
Outcome results
None listed