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
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
Study identification
- NCT ID
- NCT00094458
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- 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
- Mar 2005 (Type not available)
- Primary completion
- Apr 2008 (Actual)
- Completion
- Dec 2009 (Actual)
- Last update posted
- Feb 9, 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 9, 2017 · Synced Oct 30, 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 public registry record, listed eligibility criteria, and available contact information for NCT00094458 live on ClinicalTrials.gov.