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Completed Phase 3 Interventional Results available

Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC

ClinicalTrials.gov ID: NCT00094458

Public ClinicalTrials.gov record NCT00094458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 7:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy

Study identification

NCT ID
NCT00094458
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Centocor Ortho Biotech Services, L.L.C.
Industry
Enrollment
508 participants

Conditions and interventions

Conditions

Interventions

  • infliximab infusion; AZA placebo caps Biological
  • infliximab (IFX) infusion; azathioprine (AZA) caps Other
  • infliximab (IFX) placebo infusion; azathioprine (AZA) caps Drug

Biological · Other · Drug

Eligibility (public fields only)

Age range
21 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2005
Primary completion
Mar 31, 2008
Completion
Nov 30, 2009
Last update posted
Feb 8, 2017

2005 – 2009

United States locations

U.S. sites
51
U.S. states
24
U.S. cities
51
Facility City State ZIP Site status
Not listed Birmingham Alabama
Not listed Phoenix Arizona
Not listed Orange California
Not listed Roseville California
Not listed San Diego California
Not listed San Luis Obispo California
Not listed Golden Colorado
Not listed Littleton Colorado
Not listed Hartford Connecticut
Not listed Gainesville Florida
Not listed Jacksonville Florida
Not listed North Miami Beach Florida
Not listed Winter Park Florida
Not listed Austell Georgia
Not listed Decatur Georgia
Not listed Savannah Georgia
Not listed Peoria Illinois
Not listed Clive Iowa
Not listed Overland Park Kansas
Not listed Topeka Kansas
Not listed Baton Rouge Louisiana
Not listed Metairie Louisiana
Not listed Troy Michigan
Not listed Plymouth Minnesota
Not listed Rochester Minnesota
Not listed Ocean Springs Mississippi
Not listed Tupelo Mississippi
Not listed St Louis Missouri
Not listed Urbana Missouri
Not listed Lincoln Nebraska
Not listed Egg Harbor New Jersey
Not listed Great Neck New York
Not listed New Hyde Park New York
Not listed New York New York
Not listed Asheville North Carolina
Not listed Charlotte North Carolina
Not listed Raleigh North Carolina
Not listed Wilmington North Carolina
Not listed Bend Oregon
Not listed Portland Oregon
Not listed Hatfield Pennsylvania
Not listed Lancaster Pennsylvania
Not listed Philadelphia Pennsylvania
Not listed Pittsburgh Pennsylvania
Not listed Columbia South Carolina
Not listed Austin Texas
Not listed Houston Texas
Not listed San Antonio Texas
Not listed Bellevue Washington
Not listed Spokane Washington
Not listed Tacoma Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00094458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 8, 2017 · Synced Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00094458 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →