A Prospective Randomised Controlled Trial of Adults with Perianal Fistulising Crohn’s Disease and Optimised Therapeutic Infliximab Levels: PROACTIVE Trial

Phase 4

• Conditions: Perianal fistulising Crohn's Disease; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12621000023853
• Lead Sponsor: Associate Professor Susan Connor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Adult patients aged 18-80 years
Patients with complex perianal fistulising Crohn's disease (cpfCD) who have single or multiple externally draining perianal fistulas who are eligible for initiation of infliximab as per Pharmaceutical Benefits Scheme criteria. This incorporates patients with confirmed cpfCD 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 an externally draining perianal fistula.
Patients unexposed to infliximab within 12 months of study inclusion
Patients with previous infliximab exposure > 12 months prior to study inclusion are eligible provided they were infliximab responsive at the time of cessation or non-responsive with below target maintenance infliximab trough level (< 10 µg/mL), and if anti-infliximab antibodies were present, titres were low (=< 60 ng/mL, using Ridascreen assay).
Patients previously treated with adalimumab, if non-responsive with below target trough adalimumab levels (< 5 µg/mL), with or without detectable anti-adalimumab antibody titres.
Patients with cpfCD and concurrent luminal disease or patients with isolated perianal fistulising Crohn’s disease without luminal disease. Isolated cpfCD 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 with controlled perianal sepsis on colorectal surgeon review
Patients who are able to understand and willing to sign the informed consent as approved by the Human Research Ethics Committee. Patients must have read and understood the Patient Information and Consent Form, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments

Exclusion Criteria

Presence of a current diverting ileostomy or colostomy
Patients likely to undergo faecal stream diversion surgery in the next 3 months
Rectovaginal fistula or rectovesical fistulae
Uncontrolled perianal sepsis, as determined by colorectal surgeon review
Past failure to infliximab therapy with target maintenance infliximab trough level (>= 10µg/mL)
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
Conditions interfering with treatment compliance
Pregnancy or expected pregnancy in the next 54 weeks; breast-feeding
Participants who cannot read or understand the Patient Information and Consent Form may not be enrolled in the study by a guardian or any other individual

Study & Design

• Study Type: Interventional
• Study Design: Not specified