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

December 15, 2016 updated by: Centocor Ortho Biotech Services, L.L.C.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hall In Tirol, Austria
      • Wien, Austria
      • Bonheiden, Belgium
      • Bruxelles, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
      • Quebec, Canada
    • Ontario
      • Montreal, Ontario, Canada
      • Toronto, Ontario, Canada
      • Aalborg, Denmark
      • Aarhus C., Denmark
      • Helsinge, Denmark
      • Amiens Cedex 1, France
      • Bordeaux, France
      • Caen, France
      • Grenoble, France
      • Lille, France
      • Nancy, France
      • Paris, France
      • Toulouse, France
      • Berlin, Germany
      • Frankfurt/Main, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Herne, Germany
      • Kiel, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Minden, Germany
      • Munchen, Germany
      • Munster, Germany
      • Athens, Greece
      • Exohi, Greece
      • Heraklion- Crete, Greece
      • Nicea, Greece
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Tel-Aviv, Israel
      • Dordrecht, Netherlands
      • Eindhoven, Netherlands
      • Rotterdam, Netherlands
      • Oslo, Norway
      • Oslo N/A, Norway
      • Amadora, Portugal
      • Coimbra, Portugal
      • Barcelona, Spain
      • Madrid, Spain
      • Santander, Spain
      • Santiago De Compostela, Spain
      • Sevilla, Spain
      • Valencia, Spain
      • Linköping, Sweden
      • Lund, Sweden
      • Stockhollm, Sweden
      • Stockholm, Sweden
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Leeds, United Kingdom
      • Livingston, United Kingdom
      • London, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Stockport, United Kingdom
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Orange, California, United States
      • Roseville, California, United States
      • San Diego, California, United States
      • San Luis Obispo, California, United States
    • Colorado
      • Golden, Colorado, United States
      • Littleton, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • N Miami Beach, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Austell, Georgia, United States
      • Decatur, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Peoria, Illinois, United States
    • Iowa
      • Clive, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
      • Topeka, Kansas, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Metairie, Louisiana, United States
    • Michigan
      • Troy, Michigan, United States
    • Minnesota
      • Plymouth, Minnesota, United States
      • Rochester, Minnesota, United States
    • Mississippi
      • Ocean Springs, Mississippi, United States
      • Tupelo, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
      • Urbana, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Oregon
      • Bend, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Hatfield, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Washington
      • Bellevue, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 26
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).
Week 50
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)
Weeks 2, 6, 10, 18 and 26
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)
Weeks 34, 42 and 50
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.
Weeks 2, 6, 10, 18, 26
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.
Weeks 34, 42, 50
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).
Baseline and Weeks 2, 6, 10, 18, 26
Average Corticosteroid Use
Time Frame: Weeks 2, 6, 10, 18 and 26
Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)
Weeks 2, 6, 10, 18 and 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

October 19, 2004

First Submitted That Met QC Criteria

October 19, 2004

First Posted (ESTIMATE)

October 20, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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