MedTrace Logo

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

NCT00094458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2017-02-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Crohn Disease

Interventions

BIOLOGICAL

infliximab infusion; AZA placebo caps

Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules

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

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

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Centocor Ortho Biotech Services, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Centocor Ortho Biotech Services, L.L.C. Clinical Trial · Centocor Ortho Biotech Services, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-04-30
Completion
2009-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00094458 on ClinicalTrials.gov