Q. Which patients should I advise my colleagues to refer to me for consideration for PROFILE?
A. Any patient with likely new diagnosis of Crohn’s disease. The inclusion and exclusion criteria can then be reviewed by local clinical research team to assess if eligible for trial.
Q. Can patients still come into the trial if video recording did not take place but image capture did take place?
A. Yes, we understand this may occur if the endoscopist was not aware of the trial. Whilst video recording is preferred, patients can still be recruited if a video recording was not able to take place.
Q. The PROFILE trial has inclusion criterion of diagnosis within the last 3 months, what is considered the date of diagnosis?
A. The date of diagnosis has been determined as the clinic date that a specialist confirms diagnosis of Crohn’s disease with a patient. If previously thought ulcerative colitis and later confirmed as Crohn’s disease, the date of confirmation of Crohn’s disease would be taken as the diagnosis date.
Q. An SES-CD score was not calculated at time of ileo-colonoscopy, can we retrospectively calculate this?
A. Yes, we understand this may occur if the endoscopist was not aware of the trial. Ideally, the endoscopist performing the procedure should calculate the SES-CD score.
Q. We have a participant who was newly-diagnosed with Crohn’s disease and treated with steroids for 2 months and has flared again off-steroids, can they come into the PROFILE trial?
A. Yes. If newly-diagnosed within the last 6 months and patients meet all other inclusion criteria, as long as they have been off steroid medication for at least one week, they can undergo a screening visit and be recruited into the PROFILE trial.
Q. Can we use budesonide instead of prednisolone for PROFILE participants?
A. Yes, any steroid is allowed to be used as long as the follow the time frame of the wean i.e. 8 weeks from screening and 12 weeks form flare 1 of the step up arm.
Q. We have trialled liquid diet in a newly-diagnosed patient and they still have active disease, can they be recruited to PROFILE?
A. Yes. If ongoing active disease and otherwise the patient meets all inclusion criteria and none of the exclusion criteria, then these patients can be considered for recruitment into PROFILE.
Q. How flexible are the time windows around the scheduled trial visits?
A. Flexibility has been worked into the scheduled trial visits with a window of around 10 days for most trial visits. A detailed overview of the schedule can be found in the trial protocol. (The latest protocol can be found in the Investigator Downloads page)
Q. Can scheduled trial visits take place over the phone or do they have to be face-to-face?
A. Scheduled trial visits have to take place as face-to-face encounters. In particular, assessment of the Harvey-Bradshaw Index requires an abdominal examination. In total trial visits would typically be expected to take 60 minutes for each participant.
Q. When are steroids started for patients due to take part in the PROFILE trial?
A. Given that patients being considered for the PROFILE trial will have active disease, we recognise the importance of starting medication to help settle down inflammation and improve symptoms for patients. Therefore at the screening visit all patients will have biomarker blood test taken after providing consent and steroid medication be collected from the hospital pharmacy that day.
Q. When should stool samples be provided by patients after screening visit?
A. Patients should be encouraged to perform and send stool samples on the same day as their screening visit in order to allow processing of calprotectin result as soon as possible, as well as ensure minimal effect on steroid medication. In practice, providing the stool sample and then starting the steroid medication the following morning, seems to currently work well across sites.
Q. If randomised to the Top-Down arm, when is infliximab given and what is the infusion schedule?
A. Infliximab should be started 2 weeks after randomisation. Pencilling in an infliximab infusion date at the screening visit seems to work well across sites currently. A standard infusion regimen should then be followed i.e. (0,2,6, then 8 weekly thereafter). Sites should aim to have scheduled trial visits on the same day as infliximab infusions, to minimise hospital visits for participants.
Q. What to do if non-response or sub-optimal response to prednisolone and in Step-Up group?
A. If at baseline (randomisation) visit the patient remains significantly symptomatic with fall of HBI <3 AND HBI >7 then an ad hoc visit should be arranged for 2 weeks later with the view to escalating onto next “Step” of treatment if ongoing symptoms of active disease.
Q. What to do if non-response or sub-optimal response to infliximab in participants from either Top-down for Accelerated Step-Up?
A. If the disease flare has not adequately responded by third dose of Infliximab (HBI >7) then an additional one-off dose of Infliximab should be scheduled to take place four weeks after this third dose. This additional visit should then take place if pre-dose Infliximab serum levels from third infusion visit are confirmed to be below 20μg/ml and ongoing symptoms of active disease.
Q. What type of infliximab medication is being used for the PROFILE trial?
A. The infliximab biosimilar Remsima is currently being used for the PROFILE trial.
Q. What to do if participants develop mild intolerance to infliximab?
A. If participants develop a non-severe infusion reaction or mild allergic symptoms, then all subsequent infusions should be at a slower rate and pre-treatment given as per local guidelines.
Q. What to do if participants develop severe intolerance to infliximab?
If participants are either severely intolerant of Infliximab or experience persistent intolerance despite a slower infusion rate and pre-treatment, then they can be switched onto Adalimumab treatment. However, this is only after discussion with the Chief Investigator (Miles Parkes).
Q. Is central reading being used for endoscopies and MRE scans?
A. Yes. Central reading will be used for both endoscopic videos/images and the SES-CD score as well as MRE scans using the MaRIA score.
Q. When do MRE scans occur and what is the process of reporting or central reading?
A. MRE scans will be reported locally as per local guidelines. These anonymised images will be reviewed at the end of the trial by a central reading team using the MaRIA score.
Q. When should I request/organise end of trial ileo-colonoscopy and MRE investigations?
A. When to organise end of trial investigations is at discretion of local investigators, but typically requesting these at week 32 visit to take place after week 48 end of trial visit should allow these both end of trial ileo-colonoscopy and end of trial MRE to take place near to week 48 visit.
Page last updated: 8th August 2018