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
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
2 other identifiers
interventional
508
15 countries
115
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
Longer than P75 for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2004
CompletedFirst Posted
Study publicly available on registry
October 20, 2004
CompletedStudy Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedResults Posted
Study results publicly available
June 23, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 9, 2017
December 1, 2016
3.1 years
October 19, 2004
April 30, 2009
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Corticosteriod-free Clinical Remission
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 Outcomes (8)
Percentage of Participants With Mucosal Healing
Week 26
Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)
Week 50
Percentage of Participants With Clinical Remission (Main Study)
Weeks 2, 6, 10, 18 and 26
Percentage of Participants With Clinical Remission (Study Extension)
Weeks 34, 42 and 50
Percentage of Participants With Clinical Response Over Time (Main Study)
Weeks 2, 6, 10, 18, 26
- +3 more secondary outcomes
Study Arms (3)
003
EXPERIMENTALinfliximab (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
001
EXPERIMENTALinfliximab (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
002
EXPERIMENTALinfliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor Ortho Biotech Services, L.L.C.lead
- Schering-Ploughcollaborator
Study Sites (115)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Orange, California, United States
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Roseville, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Golden, Colorado, United States
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Littleton, Colorado, United States
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Hartford, Connecticut, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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North Miami Beach, Florida, United States
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Winter Park, Florida, United States
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Austell, Georgia, United States
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Decatur, Georgia, United States
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Savannah, Georgia, United States
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Peoria, Illinois, United States
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Clive, Iowa, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Troy, Michigan, United States
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Plymouth, Minnesota, United States
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Rochester, Minnesota, United States
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Ocean Springs, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Urbana, Missouri, United States
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Lincoln, Nebraska, United States
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Egg Harbor, New Jersey, United States
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Great Neck, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
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Hatfield, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Hall in Tirol, Austria
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Vienna, Austria
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Bonheiden, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Montreal, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Aalborg, Denmark
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Aarhus C, Denmark
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Helsinge, Denmark
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Amiens, France
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Bordeaux, France
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Caen, France
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Grenoble, France
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Lille, France
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Nancy, France
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Paris, France
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Toulouse, France
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Berlin, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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Hanover, Germany
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Herne, Germany
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Kiel, Germany
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Magdeburg, Germany
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Mainz, Germany
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Minden, Germany
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München, Germany
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Münster, Germany
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Athens, Greece
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Eksochi, Greece
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Heraklion- Crete, Greece
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Nicea, Greece
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Dordrecht, Netherlands
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Eindhoven, Netherlands
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Rotterdam, Netherlands
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Oslo, Norway
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Amadora, Portugal
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Coimbra, Portugal
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Barcelona, Spain
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Madrid, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Linköping, Sweden
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Lund, Sweden
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Stockhollm, Sweden
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Stockholm, Sweden
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Bristol, United Kingdom
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Cambridge, United Kingdom
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Leeds, United Kingdom
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Livingston, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Stockport, United Kingdom
Related Publications (7)
Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.
PMID: 20393175RESULTDulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.
PMID: 34216825DERIVEDColombel JF, Adedokun OJ, Gasink C, Gao LL, Cornillie FJ, D'Haens GR, Rutgeerts PJ, Reinisch W, Sandborn WJ, Hanauer SB. Combination Therapy With Infliximab and Azathioprine Improves Infliximab Pharmacokinetic Features and Efficacy: A Post Hoc Analysis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1525-1532.e1. doi: 10.1016/j.cgh.2018.09.033. Epub 2018 Sep 26.
PMID: 30267864DERIVEDColombel JF, Reinisch W, Mantzaris GJ, Kornbluth A, Rutgeerts P, Tang KL, Oortwijn A, Bevelander GS, Cornillie FJ, Sandborn WJ. Randomised clinical trial: deep remission in biologic and immunomodulator naive patients with Crohn's disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015 Apr;41(8):734-46. doi: 10.1111/apt.13139. Epub 2015 Mar 1.
PMID: 25728587DERIVEDReinisch W, Colombel JF, Sandborn WJ, Mantzaris GJ, Kornbluth A, Adedokun OJ, Miller M, Tang KL, Rutgeerts P, Cornillie F. Factors associated with short- and long-term outcomes of therapy for Crohn's disease. Clin Gastroenterol Hepatol. 2015 Mar;13(3):539-547.e2. doi: 10.1016/j.cgh.2014.09.031. Epub 2014 Sep 19.
PMID: 25245629DERIVEDPeyrin-Biroulet L, Reinisch W, Colombel JF, Mantzaris GJ, Kornbluth A, Diamond R, Rutgeerts P, Tang LK, Cornillie FJ, Sandborn WJ. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial. Gut. 2014 Jan;63(1):88-95. doi: 10.1136/gutjnl-2013-304984. Epub 2013 Aug 23.
PMID: 23974954DERIVEDFerrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens GR, van der Woude CJ, Danese S, Diamond RH, Oortwijn AF, Tang KL, Miller M, Cornillie F, Rutgeerts PJ; International Organization for the Study of Inflammatory Bowel Diseases. Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013 Nov;145(5):978-986.e5. doi: 10.1053/j.gastro.2013.08.010. Epub 2013 Aug 14.
PMID: 23954314DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Centocor Ortho Biotech Services, L.L.C.
Study Officials
- STUDY DIRECTOR
Centocor Ortho Biotech Services, L.L.C. Clinical Trial
Centocor Ortho Biotech Services, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2004
First Posted
October 20, 2004
Study Start
March 1, 2005
Primary Completion
April 1, 2008
Study Completion
December 1, 2009
Last Updated
February 9, 2017
Results First Posted
June 23, 2009
Record last verified: 2016-12