ISOMETRIC CD (Efficacy of subcutaneous infliximab maintenance therapy in perianal Crohn’s disease.

Not Applicable

• Conditions: perianal Crohn’s disease; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12622001310752
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-11
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified