Switching patients from intravenous to subcutaneous infliximab in inflammatory bowel disease

Phase 4

Recruiting

• Conditions: lcerative colitis; Ulcerative colitis; Oral and Gastrointestinal - Inflammatory bowel disease; Crohn's disease; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12621001498886
• Lead Sponsor: Concord Repatriation General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-04
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

·Diagnosis of ulcerative colitis or Crohn's disease
·On IV infliximab treatment – must be on maintenance treatment at 5mg/kg dosing every 8 weeks
·Steroids-free clinical remission and/or biochemical remission for at least 12 weeks
a.Clinical remission:
i. Ulcerative colitis: Partial Mayo Score (pMS) < 2
ii. Crohn's disease: Harvey Bradshaw Index (HBI) < 5 points
b.Biochemical remission:
i. C-reactive protein (CRP) < 5mg/L
ii. Faecal calprotectin < 150 µg/mL

Exclusion Criteria

- Age < 18 years
- Patients awaiting bowel surgery
- Patients with a stoma
- Consent not obtained or unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified