Clinical trial
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of…
NCT00094458 · Centocor Ortho Biotech Services, L.L.C., Industry · Completed
Key facts
| NCT number | NCT00094458 |
|---|---|
| Title | Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease nave to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC |
| 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 |
| Lead sponsor | Centocor Ortho Biotech Services, L.L.C., Industry |
| Collaborators | Schering-Plough Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Intervention type | Biological, Drug, Other |
| Interventions | infliximab infusion, AZA placebo caps, infliximab (IFX) infusion, azathioprine (AZA) caps, infliximab (IFX) placebo infusion |
| Enrollment | 508 |
| Start date | Mar 1, 2005 |
| Primary completion | Apr 1, 2008 |
| Completion | Dec 1, 2009 |
| First posted | Oct 20, 2004 |
| Last update posted | Feb 9, 2017 |
| Countries | Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Netherlands, Norway, Portugal, Spain and 3 more |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: