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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
508

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Austria
      • Hall In Tirol, Austria
      • Wien, Austria
  • Belgium
      • Bonheiden, Belgium
      • Bruxelles, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Canada
      • Quebec, Canada
    • Ontario
      • Montreal, Ontario, Canada
      • Toronto, Ontario, Canada
  • Denmark
      • Aalborg, Denmark
      • Aarhus C., Denmark
      • Helsinge, Denmark
  • France
      • Amiens Cedex 1, France
      • Bordeaux, France
      • Caen, France
      • Grenoble, France
      • Lille, France
      • Nancy, France
      • Paris, France
      • Toulouse, France
  • Germany
      • Berlin, Germany
      • Frankfurt/Main, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Herne, Germany
      • Kiel, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Minden, Germany
      • Munchen, Germany
      • Munster, Germany
  • Greece
      • Athens, Greece
      • Exohi, Greece
      • Heraklion- Crete, Greece
      • Nicea, Greece
  • Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Tel-Aviv, Israel
  • Netherlands
      • Dordrecht, Netherlands
      • Eindhoven, Netherlands
      • Rotterdam, Netherlands
  • Norway
      • Oslo, Norway
      • Oslo N/A, Norway
  • Portugal
      • Amadora, Portugal
      • Coimbra, Portugal
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Santander, Spain
      • Santiago De Compostela, Spain
      • Sevilla, Spain
      • Valencia, Spain
  • Sweden
      • Linköping, Sweden
      • Lund, Sweden
      • Stockhollm, Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Leeds, United Kingdom
      • Livingston, United Kingdom
      • London, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Stockport, United Kingdom
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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
EXPERIMENTAL: 002
infliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
Biological: infliximab infusion; AZA placebo caps
Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centocor Ortho Biotech Services, L.L.C.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Schering-Plough

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2005

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2004

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR004804
  • C0168T67

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