ACTRN12621001498886RecruitingPhase 4
Comparison between switching from intravenous to subcutaneous infliximab on the maintenance of clinical and biochemical remission in patients with inflammatory bowel disease
Concord Repatriation General Hospital0 sites176 target enrollmentStarted: November 4, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 176
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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
Investigators
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