NCT01181765

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

August 12, 2010

Last Update Submit

December 13, 2013

Conditions

Crohn's Disease

Keywords

Crohn's Diseaseinfliximabcapsule endoscopy

Outcome Measures

Primary Outcomes (1)

  • Endoscopic Improvement

    Mean change in Lewis score between Baseline and Week 26

    Week 26

Secondary Outcomes (3)

  • Clinical improvement

    Week 26

  • Early endoscopic improvement

    Week 10

  • Clinical Improvement

    Week 10

Study Arms (1)

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

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

Interventions

Infliximab 5 mg/kg body weight infused over 2 hoursBIOLOGICAL

Subjects will receive IV Infusion of infliximab 5 mg/kg body weight at Week 0, Week 2, Week 6, Week 14 and Week 22 as per the approved Canadian product monograph of infliximab.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications to anti-TNF therapy (TB, cardiac impairment, etc.)
  • Prior bowel resection
  • Prior anti-TNF exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Janssen Inc. Clinical Trial

    Janssen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 13, 2010

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

CA(2)