Phase 3
Completed N=508
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
Crohn Disease
Source: ClinicalTrials.gov NCT00094458 ↗
Enrolled (actual)
508
Serious AEs
14.2%
Results posted
Jun 2009
Primary outcomePrimary: Percentage of Participants With Corticosteriod-free Clinical Remission — 30.0; 44.4; 56.8 percentage of participants — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Corticosteriod-free Clinical Remission |
30.0; 44.4; 56.8 | <0.001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing |
16.5; 30.1; 43.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension) |
54.7; 60.8; 72.2 | — |
| SECONDARY Percentage of Participants With Clinical Remission (Main Study) |
17.6; 32.5; 36.7; 27.6; 49.1; 52.1 | — |
| SECONDARY Percentage of Participants With Clinical Remission (Study Extension) |
61.3; 66.0; 69.4; 58.7; 72.2; 73.1 | — |
| SECONDARY Percentage of Participants With Clinical Response Over Time (Main Study) |
22.4; 42.6; 47.3; 37.6; 54.4; 63.3 | — |
| SECONDARY Percentage of Participants With Clinical Response Over Time (Study Extension) |
66.7; 76.3; 76.9; 65.3; 74.2; 77.8 | — |
| SECONDARY Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study) |
20.1; 27.7; 31.4; 28.3; 34.8; 39.9 | — |
| SECONDARY Average Corticosteroid Use |
22.92; 21.20; 22.75; 18.56; 17.68; 18.26 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00094458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.