The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (ICE)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Biological: Infliximab 5 mg/kg body weight infused over 2 hours

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181765

P05088 (Other Identifier)

CR100747

Details and patient eligibility

About

This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining healing of lesions in the mucosa of subjects with Crohn's disease involving their small bowel.

Full description

Landmark trials in Crohn's disease demonstrated the efficacy of infliximab in inducing and maintaining clinical remission. Furthermore, the endoscopic sub-studies within these trials demonstrated the ability of infliximab to rapidly induce and maintain mucosal healing as evidenced by the complete absence of mucosal breaks in the colon and terminal ileum. Unfortunately, conventional colonoscopy does not allow intestinal exploration beyond a very restricted portion of the small bowel (at most 10-15 cm of the terminal ileum). A study that systematically examines the changes in the small bowel mucosa during Crohn's disease symptomatic improvement is clearly needed.

This study consists of 20 subjects and 30 weeks of follow up. All subjects will undergo wireless camera endoscopy at three (3) visits, namely: at Screening, at Week 10 and at Week 26. Infliximab is administered at (5) visits, namely: at Baseline (week 0), Week 2, Week 6, Week 14 and Week 22. In some subjects, an ileal-colonoscopy may be performed at Week 26.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 18 years old
• Established diagnosis of Crohn's disease and evidence of small bowel involvement
• CDAI score between 220 and 450 inclusively
• Lewis score of at least 790 at Screening
• Colonoscopy within the last 6 months
• Successful excretion of the intact patency capsule Exclusion Criteria
• Contraindications to anti-TNF therapy (TB, cardiac impairment, etc.)
• Prior bowel resection
• Prior anti-TNF exposure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Infliximab infusions (5 mg/kg) at weeks 0, 2, 6, 14 and 22

Experimental group

Treatment:

Biological: Infliximab 5 mg/kg body weight infused over 2 hours