NCT00207662

Brief Summary

This is a study of infliximab (Remicade) in subjects with Crohn's disease

Trial Health

100
On Track

Trial Health Score

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

Enrollment
580

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_3

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

Study Start

First participant enrolled

July 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

April 26, 2010

Conditions

Crohn Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Reductions in the signs and symptoms of Crohn's disease

Secondary Outcomes (1)

  • Clinical remission;reduction in the use corticosteroids; mucosal healing

Interventions

infliximab or placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • Men and women \>=18 years of age
  • Diagnosis of Crohn's
  • Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography or endoscopy

You may not qualify if:

  • Local manifestations of Crohn's disease such as strictures, abscesses, or other disease
  • Surgery for bowel diversion with placement of a stoma within 3 months prior to beginning the study
  • Positive stool culture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Rutgeerts P, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Hanauer SB. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. Gastroenterology. 2004 Feb;126(2):402-13. doi: 10.1053/j.gastro.2003.11.014.

    PMID: 14762776RESULT

  • Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.

    PMID: 12047962RESULT

  • Reinisch W, Wang Y, Oddens BJ, Link R. C-reactive protein, an indicator for maintained response or remission to infliximab in patients with Crohn's disease: a post-hoc analysis from ACCENT I. Aliment Pharmacol Ther. 2012 Mar;35(5):568-76. doi: 10.1111/j.1365-2036.2011.04987.x. Epub 2012 Jan 18.

    PMID: 22251435DERIVED

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

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2000

Study Completion

November 1, 2005

Last Updated

April 27, 2010

Record last verified: 2010-04