A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207766

Enrollment

306

Registered

2005-09-21

Start date

2000-06-30

Completion date

2006-08-31

Last updated

2010-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn's Disease, infusions

Brief summary

A study of infliximab in patients with Fistulizing Crohn's Disease

Detailed description

This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas. Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.

Interventions

DRUGinfliximab or placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Single or multiple draining fistulas * Crohn's disease of at least 3 months' duration,

Exclusion criteria

* Crohn's disease complications for which surgery might be indicated * Positive stool culture

Design outcomes

Primary

Measure	Time frame
Reduction in the number of draining fistulas	—

Secondary

Measure	Time frame
Complete fistula response (no draining fistula).	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026