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Crohn DiseasePhase 3NCT00094458

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

A Phase 3 study testing infliximab (IFX) infusion; azathioprine (AZA) caps in people with Crohn Disease, run by Centocor Ortho Biotech Services, L.L.C. at 115 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Crohn Disease
What is being tested?
infliximab (IFX) infusion; azathioprine (AZA) caps
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
508 participants
Where
115 sitesin 15 countries
Study dates
Mar 2005to Dec 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

115 sites in 15 countries.

115 sites in 15 countries

United States51 sites

  • Study site

    Asheville, North Carolina

  • Study site

    Austell, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bellevue, Washington

  • Study site

    Bend, Oregon

  • Study site

    Birmingham, Alabama

  • Study site

    Charlotte, North Carolina

  • Study site

    Clive, Iowa

  • Study site

    Columbia, South Carolina

  • Study site

    Decatur, Georgia

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Gainesville, Florida

  • Study site

    Golden, Colorado

  • Study site

    Great Neck, New York

  • Study site

    Hartford, Connecticut

  • Study site

    Hatfield, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lincoln, Nebraska

  • Study site

    Littleton, Colorado

  • Study site

    Metairie, Louisiana

  • Study site

    New Hyde Park, New York

  • Study site

    New York, New York

  • Study site

    North Miami Beach, Florida

  • Study site

    Ocean Springs, Mississippi

  • Study site

    Orange, California

  • Study site

    Overland Park, Kansas

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plymouth, Minnesota

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, Minnesota

  • Study site

    Roseville, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Luis Obispo, California

  • Study site

    Savannah, Georgia

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tacoma, Washington

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

  • Study site

    Tupelo, Mississippi

  • Study site

    Urbana, Missouri

  • Study site

    Wilmington, North Carolina

  • Study site

    Winter Park, Florida

Other trials in United States

Germany11 sites

  • Study site

    Berlin

  • Study site

    Frankfurt am Main

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Herne

  • Study site

    Kiel

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Minden

  • Study site

    München

  • Study site

    Münster

Other trials in Germany

France8 sites

  • Study site

    Amiens

  • Study site

    Bordeaux

  • Study site

    Caen

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Nancy

  • Study site

    Paris

  • Study site

    Toulouse

Other trials in France

United Kingdom7 sites

  • Study site

    Bristol

  • Study site

    Cambridge

  • Study site

    Leeds

  • Study site

    Livingston

  • Study site

    London

  • Study site

    Newcastle upon Tyne

  • Study site

    Stockport

Other trials in United Kingdom

Spain6 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Santander

  • Study site

    Santiago de Compostela

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Belgium5 sites

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Roeselare

Other trials in Belgium

Israel5 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Tel Aviv

Other trials in Israel

Greece4 sites

  • Study site

    Athens

  • Study site

    Eksochi

  • Study site

    Heraklion- Crete

  • Study site

    Nicea

Other trials in Greece

Sweden4 sites

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Stockhollm

  • Study site

    Stockholm

Other trials in Sweden

Canada3 sites

  • Study site

    Montreal, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

Denmark3 sites

  • Study site

    Aalborg

  • Study site

    Aarhus C

  • Study site

    Helsinge

Other trials in Denmark

Netherlands3 sites

  • Study site

    Dordrecht

  • Study site

    Eindhoven

  • Study site

    Rotterdam

Other trials in Netherlands

Austria2 sites

  • Study site

    Hall in Tirol

  • Study site

    Vienna

Other trials in Austria

Portugal2 sites

  • Study site

    Amadora

  • Study site

    Coimbra

Other trials in Portugal

Norway1 site

  • Study site

    Oslo

Other trials in Norway

About this study

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

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.

Read the 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.

Conditions
Crohn Disease
Being tested
infliximab infusion; AZA placebo caps, infliximab (IFX) infusion; azathioprine (AZA) caps, infliximab (IFX) placebo infusion; azathioprine (AZA) caps
Keywords
Crohn's Disease, infliximab, azathioprine, Remicade, SONIC
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infliximab infusion; AZA placebo capsBiological

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

  • infliximab (IFX) infusion; azathioprine (AZA) capsOther

    AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22

  • infliximab (IFX) placebo infusion; azathioprine (AZA) capsDrug

    AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22

Study groups in NCT00094458
Study groupRoleWhat they receive
003Experimentalinfliximab (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
Receives: Other: infliximab (IFX) infusion; azathioprine (AZA) caps
001Experimentalinfliximab (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
Receives: Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
002Experimentalinfliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
Receives: Biological: infliximab infusion; AZA placebo caps

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 26

Secondary outcomes (8)

  1. Percentage of Participants With Mucosal Healing

    Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.

    Measured: Week 26

  2. Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)

    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).

    Measured: Week 50

  3. Percentage of Participants With Clinical Remission (Main Study)

    Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)

    Measured: Weeks 2, 6, 10, 18 and 26

  4. Percentage of Participants With Clinical Remission (Study Extension)

    Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)

    Measured: Weeks 34, 42 and 50

  5. Percentage of Participants With Clinical Response Over Time (Main Study)

    Clinical response, defined as a >=100-point decrease in CDAI from Baseline.

    Measured: Weeks 2, 6, 10, 18, 26

  6. Percentage of Participants With Clinical Response Over Time (Study Extension)

    Clinical response, defined as a >=100-point decrease in CDAI from Baseline.

    Measured: Weeks 34, 42, 50

  7. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)

    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).

    Measured: Baseline and Weeks 2, 6, 10, 18, 26

  8. Average Corticosteroid Use

    Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)

    Measured: Weeks 2, 6, 10, 18 and 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2004 (estimated)
  2. Study startMar 2005
  3. Primary completionApr 2008
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00094458
Sponsor's protocol ID
CR004804
Other IDs
C0168T67
Status last verified
Dec 2016
First submitted
19 Oct 2004
Last updated
9 Feb 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 20393175

  • Dulai 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.

    PubMed 34216825

  • Colombel 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.

    PubMed 30267864

  • Colombel 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.

    PubMed 25728587

  • Reinisch 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.

    PubMed 25245629

  • Peyrin-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.

    PubMed 23974954

  • Ferrante 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.

    PubMed 23954314

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing infliximab (IFX) infusion; azathioprine (AZA) caps in people with Crohn Disease, run by Centocor Ortho Biotech Services, L.L.C. at 115 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Germany, France, United Kingdom, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Corticosteriod-free Clinical Remission (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094458, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.

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