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
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ClinicalTrials.gov Identifier: NCT00094458 |
Recruitment Status :
Completed
First Posted : October 20, 2004
Results First Posted : June 23, 2009
Last Update Posted : February 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn Disease | Biological: infliximab infusion; AZA placebo caps Other: infliximab (IFX) infusion; azathioprine (AZA) caps Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 508 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | March 2005 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 003
infliximab (IFX) infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22
|
Other: infliximab (IFX) infusion; azathioprine (AZA) caps
AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22 |
Experimental: 001
infliximab (IFX) placebo infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
|
Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22 |
Experimental: 002
infliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
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Biological: infliximab infusion; AZA placebo caps
Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules |
- Percentage of Participants With Corticosteriod-free Clinical Remission [ Time Frame: Week 26 ]Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
- Percentage of Participants With Mucosal Healing [ Time Frame: Week 26 ]Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.
- Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension) [ Time Frame: Week 50 ]Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
- Percentage of Participants With Clinical Remission (Main Study) [ Time Frame: Weeks 2, 6, 10, 18 and 26 ]Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
- Percentage of Participants With Clinical Remission (Study Extension) [ Time Frame: Weeks 34, 42 and 50 ]Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
- Percentage of Participants With Clinical Response Over Time (Main Study) [ Time Frame: Weeks 2, 6, 10, 18, 26 ]Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
- Percentage of Participants With Clinical Response Over Time (Study Extension) [ Time Frame: Weeks 34, 42, 50 ]Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
- 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 ]Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).
- Average Corticosteroid Use [ Time Frame: Weeks 2, 6, 10, 18 and 26 ]Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)

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Ages Eligible for Study: | 21 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094458

Study Director: | Centocor Ortho Biotech Services, L.L.C. Clinical Trial | Centocor Ortho Biotech Services, L.L.C. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Centocor Ortho Biotech Services, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00094458 |
Other Study ID Numbers: |
CR004804 C0168T67 |
First Posted: | October 20, 2004 Key Record Dates |
Results First Posted: | June 23, 2009 |
Last Update Posted: | February 9, 2017 |
Last Verified: | December 2016 |
Crohn's Disease infliximab azathioprine Remicade SONIC |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Azathioprine Infliximab Dermatologic Agents |
Gastrointestinal Agents Antirheumatic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |