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

PHASE3CompletedINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

April 30, 2008

Study Completion Date

December 31, 2009

Conditions
Crohn Disease
Interventions
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

Trial Locations (115)

Unknown

Birmingham

Phoenix

Orange

Roseville

San Diego

San Luis Obispo

Golden

Littleton

Hartford

Gainesville

Jacksonville

North Miami Beach

Winter Park

Austell

Decatur

Savannah

Peoria

Clive

Overland Park

Topeka

Baton Rouge

Metairie

Troy

Plymouth

Rochester

Ocean Springs

Tupelo

St Louis

Urbana

Lincoln

Egg Harbor

Great Neck

New Hyde Park

New York

Asheville

Charlotte

Raleigh

Wilmington

Bend

Portland

Hatfield

Lancaster

Philadelphia

Pittsburgh

Columbia

Austin

Houston

San Antonio

Bellevue

Spokane

Tacoma

Hall in Tirol

Vienna

Bonheiden

Brussels

Leuven

Liège

Roeselare

Montreal

Toronto

Québec

Aalborg

Aarhus C

Helsinge

Amiens

Bordeaux

Caen

Grenoble

Lille

Nancy

Paris

Toulouse

Berlin

Frankfurt am Main

Hamburg

Hanover

Herne

Kiel

Magdeburg

Mainz

Minden

München

Münster

Athens

Eksochi

Heraklion- Crete

Nicea

Haifa

Jerusalem

Kfar Saba

Petah Tikva

Tel Aviv

Dordrecht

Eindhoven

Rotterdam

Oslo

Amadora

Coimbra

Barcelona

Madrid

Santander

Santiago de Compostela

Seville

Valencia

Linköping

Lund

Stockhollm

Stockholm

Bristol

Cambridge

Leeds

Livingston

London

Newcastle upon Tyne

Stockport

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Centocor Ortho Biotech Services, L.L.C.

INDUSTRY

NCT00094458 - 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 | Biotech Hunter | Biotech Hunter