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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00094458
Date of registration: 19/10/2004
Prospective Registration: Yes
Primary sponsor: Centocor Ortho Biotech Services, L.L.C.
Public title: 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
Scientific 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
Date of first enrolment: March 2005
Target sample size: 508
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00094458
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Austria Belgium Canada Denmark France Germany Greece Israel
Netherlands Norway Portugal Spain Sweden United Kingdom United States
Contacts
Name:     Centocor Ortho Biotech Services, L.L.C. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Centocor Ortho Biotech Services, L.L.C.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Crohns Disease for at least 6 weeks

- Moderate to severe disease activity (CDAI >= 220 and <=450)

- No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments

- Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of
corticosteriod, OR 5-ASA failures, Or Budesonide failures

Exclusion Criteria:

- History of abdominal surgery within the last 6 months

- Have an ostomy or stoma [An operation to create an opening from an area inside the
body to the outside]

- Are pregnant, nursing, or planning pregnancy (both men and women)

- Serious simultaneous illness that could interfere with study participation

- Use of any investigational drug within 30 days

- Have a concomitant diagnosis or any history of congestive heart failure

- Weigh more than 140 kilograms (or 310 pounds)



Age minimum: 21 Years
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Biological: infliximab infusion; AZA placebo caps
Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
Other: infliximab (IFX) infusion; azathioprine (AZA) caps
Primary Outcome(s)
Percentage of Participants With Corticosteriod-free Clinical Remission [Time Frame: Week 26]
Secondary Outcome(s)
Average Corticosteroid Use [Time Frame: Weeks 2, 6, 10, 18 and 26]
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study) [Time Frame: Baseline and Weeks 2, 6, 10, 18, 26]
Percentage of Participants With Clinical Remission (Main Study) [Time Frame: Weeks 2, 6, 10, 18 and 26]
Percentage of Participants With Clinical Remission (Study Extension) [Time Frame: Weeks 34, 42 and 50]
Percentage of Participants With Clinical Response Over Time (Main Study) [Time Frame: Weeks 2, 6, 10, 18, 26]
Percentage of Participants With Clinical Response Over Time (Study Extension) [Time Frame: Weeks 34, 42, 50]
Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension) [Time Frame: Week 50]
Percentage of Participants With Mucosal Healing [Time Frame: Week 26]
Secondary ID(s)
C0168T67
CR004804
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Schering-Plough
Ethics review
Results
Results available: Yes
Date Posted: 23/06/2009
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00094458
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