None listed
Conditions
Brief summary
Infliximab is the mainstay of treatment in perianal fistulising Crohn’s disease. It has previously only been administered via infusions for perianal fistulising Crohn’s disease. Subcutaneously delivered infliximab has recently been approved by the Therapeutic Goods Administration for perianal fistulising Crohn’s disease. Real-world data has demonstrated that switching from intravenous to subcutaneous infliximab in patients with disease of their bowel is safe and effective. However, there is currently a lack of data regarding the efficacy or treatment persistence in patients switched from intravenous to subcutaneous infliximab in perianal fistulising Crohn’s disease. Our study involves switching patients from intravenous to subcutaneous infliximab and evaluating how many patients continue to take this medication at 12 months. Secondarily, we will look at how effective this drug is at treating perianal fistulising Crohn’s disease with a variety of measures
Interventions
SWITCH IV INFLIXIMAB TO SUB CUTANEOUS INFLIXIMAB.
Eligible patients for the study with be consented. Eligible patients are those with perianal fistulising Crohn’s disease who have been on a stable infliximab dose for three months. Patients will change to subcutaneous infliximab from intravenous infliximab. Standard subcutaneous dosing will be 120mg fortnightly. First dose will be administered 8 weeks after their last infliximab infusion. This would correspond as to when they would have received
SWITCH IV INFLIXIMAB TO SUB CUTANEOUS INFLIXIMAB. Eligible patients for the study with be consented. Eligible patients are those with perianal fistulising Crohn’s disease who have been on a stable infliximab dose for three months. Patients will change to subcutaneous infliximab from intravenous infliximab. Standard subcutaneous dosing will be 120mg fortnightly. First dose will be administered 8 weeks after their last infliximab infusion. This would correspond as to when they would have received another infliximab infusion. Patients will get infliximab serum trough drug levels at 3, 6 and 12 months to assess if levels are therapeutic (considered standard of care). (Serum drug levels are a blood test to measure how much Infliximab is in the blood.) Infliximab can be increased/decreased at the clinician’s discretion. Clinicians may adjust infliximab dosing based on clinical, radiological, biochemical assessments of disease or infliximab trough levels at their discretion. Infusions will occur in house at the tertiary hospital. Sub cutaneious Infliximab can be self administered by the participants or by a health care professional. This will be a choice made by the participants. administration of Infliximab will occur for as long as required as per local hospital guidelines . Patients who cease subcutaneous infliximab due to treatment failure of the subcutaneous infliximab will continue care with their usual gastroenterologist. They will be assessed for clinical response, fistula healing and closure, and have blood tests, faecal calprotectin and a pelvic MRI completed. Their clinical progress and medication history will be followed-up until they reach 12 months and data on any major adverse outcomes such as Crohn's disease-related surgery, hospitalisation, and persistence of infliximab use will be collated.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adult patients, male or female aged 18 years to 75 years old Patients with pfCD who have or have had single or multiple externally draining perianal fistulas who are eligible for maintenance therapy infliximab as per Pharmaceutical Benefits Scheme criteria. This incorporates patients with confirmed pfCD treated by a gastroenterologist or a consultant physician in either internal or general medicine specialising in gastroenterology; with Crohn's disease confirmed by standard clinical, endoscopic or radiological assessment; and who have/had an externally draining perianal fistula. Patients on a stable dose of infliximab for 3 months (between 5mg/kg and 10mg/kg every 8 weeks (as maximum dosing)). Patients with pfCD and concurrent luminal disease or patients with isolated perianal fistulising Crohn's disease without luminal disease. Isolated pfCD will be defined as perianal fistulas with typical histological features of Crohn's disease Patients with or without a seton in situ Patients with concurrent or previous therapies for Crohn's disease including 5-aminosalicylic acids, thiopurines, methotrexate and corticosteroids Patients who have previously trialled non-anti-TNF biologic or small molecule agents Patients without presence of an abscess or perianal fistula on physical exam Patients with rectovaginal, rectovesical, and/or enteroenteric fistulas with at least one separate perianal (anorectal) fistula with active external draining or that was previously draining/present
Exclusion criteria
Patients who have commenced infliximab within the last 3 months Patients who have undergone escalation of infliximab within the last 3 months Patients on more than 20mg of prednisolone Patients planned to undergo faecal stream diversion surgery in the next 3 months Uncontrolled perianal sepsis, as determined by colorectal surgeon review Usual Pharmaceutical Benefits Scheme exclusions to infliximab therapy including active systemic infections, untreated latent tuberculosis, malignancy in the last 5 years with the exception of non-melanoma skin cancer, untreated Clostridium difficile infection, moderate to severe heart failure, known systemic lupus erythematosus or connective tissue disorder, and autoimmune demyelinating conditions
Outcome results
None listed