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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

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ClinicalTrials.gov Identifier: NCT00094458
Recruitment Status : Completed
First Posted : October 20, 2004
Results First Posted : June 23, 2009
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Biological: infliximab infusion; AZA placebo caps Other: infliximab (IFX) infusion; azathioprine (AZA) caps Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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)

  4. 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)

  5. 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.

  6. 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.

  7. 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).

  8. Average Corticosteroid Use [ Time Frame: Weeks 2, 6, 10, 18 and 26 ]
    Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094458


Locations
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Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Schering-Plough
Investigators
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Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00094458    
Other Study ID Numbers: CR004804
C0168T67
First Posted: October 20, 2004    Key Record Dates
Results First Posted: June 23, 2009
Last Update Posted: February 9, 2017
Last Verified: December 2016
Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Crohn's Disease
infliximab
azathioprine
Remicade
SONIC
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Azathioprine
Infliximab
Dermatologic Agents
 Gastrointestinal Agents
Antirheumatic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs