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
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Crohns disease is characterized by inflammation (the changes that happen when tissues in the
      body are injured) and ulceration (open sores) of the intestines. Crohns disease is treated
      with medications that decrease inflammation, and reduce diarrhea, abdominal pain and other
      symptoms of Crohns disease. In addition, Crohns disease can be treated with medications that
      suppress the immune system (the body system involved in inflammation and infections) or with
      surgery. This study will investigate the effectiveness of infliximab and azathioprine in the
      treatment of patients with moderate-to-severe Crohns disease. Infliximab is currently
      approved by the FDA for the treatment of both Crohns disease and rheumatoid arthritis.
      Azathioprine, which is an investigational drug, has not been approved by the FDA for the
      treatment of Crohns disease, but it is a well-established therapy that has been used for many
      years to treat Crohns disease. This study seeks to determine whether infliximab,
      azathioprine, or the combination of both drugs would be the most appropriate treatment for
      Crohns disease patients who have not responded well to certain drugs called 5-ASA drugs (e.g.
      Asacol, Pentasa, sulfasalazine) and/or require frequent treatment with corticosteroids. This
      research study will involve approximately 500 patients. Patients may participate in the main
      study for up to 34 weeks (approximately 8 months). During the main study, patients will be
      asked to visit the study center for 10 visits. If patients enroll into the extension of the
      study, the total time for participation may be up to 54 weeks (approximately 13 months).
      Patients enrolled in the Study Extension will be asked to visit the study center for an
      additional 5 visits. A country-specific (EU and Israel only), prospective, multi-center,
      open-label extension of the study will further evaluate the long-term safety and efficacy of
      scheduled maintenance therapy with infliximab in patients with Crohns Disease. Patients who
      have completed treatment through Week 50 in the SONIC main study and who, in the opinion of
      the investigator, would benefit from infliximab treatment may enter the open-label extension.
      Patients will be randomly assigned to one of three treatment groups (either infliximab plus
      placebo capsules, infliximab plus azathioprine, or azathioprine plus placebo infusions -
      there is no possibility of being assigned to placebo only in this trial - patients will
      receive one or both of these medications) at the beginning of the study. Oral medication will
      be taken daily. There are 5 infusion (which will be either infliximab or placebo) visits
      during the main study.
    

Intervention name(s): infliximab infusion; AZA placebo caps; infliximab (IFX) infusion; azathioprine (AZA) caps; infliximab (IFX) placebo infusion; azathioprine (AZA) caps
Intervention type(s): Biological; Other; Drug
Intervention description(s): Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules; AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22; AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
Intervention MeSH terms: Infliximab; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease; infliximab; azathioprine; Remicade; SONIC