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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.

Tracking Information
First Submitted Date  ICMJE October 19, 2004
First Posted Date  ICMJE October 20, 2004
Results First Submitted Date  ICMJE April 30, 2009
Results First Posted Date  ICMJE June 23, 2009
Last Update Posted Date February 9, 2017
Study Start Date  ICMJE March 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Steroid-free remission
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
  • 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.
  • 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).
  • 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)
  • 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)
  • 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.
  • 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.
  • 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).
  • Average Corticosteroid Use [ Time Frame: Weeks 2, 6, 10, 18 and 26 ]
    Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Other: infliximab (IFX) infusion; azathioprine (AZA) caps
  • 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
    Intervention: Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
  • Experimental: 002
    infliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
    Intervention: Biological: infliximab infusion; AZA placebo caps
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2009)
508
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
500
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Greece,   Israel,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00094458
Other Study ID Numbers  ICMJE CR004804
C0168T67
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centocor Ortho Biotech Services, L.L.C.
Study Sponsor  ICMJE Centocor Ortho Biotech Services, L.L.C.
Collaborators  ICMJE Schering-Plough
Investigators  ICMJE
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
PRS Account Centocor Ortho Biotech Services, L.L.C.
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP