Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

PHASE3CompletedINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

July 31, 2013

Study Completion Date

October 31, 2013

Conditions
ArthritisArthritis, RheumatoidAutoimmune Diseases
Interventions
DRUG

Golimumab 50 mg SC

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

DRUG

Golimumab 2 mg/kg IV

Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.

DRUG

Methotrexate (MTX)

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

DRUG

Placebo SC

Placebo matched to golimumab SC injection every 4 weeks.

DRUG

Placebo IV

Placebo matched to golimumab intravenous infusion every 8 weeks.

Trial Locations (117)

Unknown

Birmingham

Huntsville

Tuscaloosa

Mesa

Phoenix

Hot Springs

Little Rock

Covina

Hemet

Loma Linda

Long Beach

Murrieta

Santa Maria

Santa Monica

Torrance

Van Nuys

Victorville

Whittier

Bridgeport

Hamden

Trumbull

Aventura

Fort Lauderdale

Jacksonville

Naples

Orange Park

Orlando

Palm Harbor

Plantation

Sarasota

Tampa

Duluth

Coeur d'Alene

Idaho Falls

Rockford

South Bend

Bettendorf

Kansas City

Bowling Green

Monroe

New Orleans

Wheaton

Rochester

Flowood

Tupelo

Clayton

Florissant

Lincoln

Freehold

Brooklyn

Mineola

Plainview

Rochester

Smithtown

Charlotte

Greenville

Hickory

Wilmington

Akron

Columbus

Mayfield

Middleburg Heights

Edmond

Oklahoma City

Lake Oswego

Bethlehem

Duncansville

West Reading

Wexford

Charleston

Columbia

Myrtle Beach

Hixson

Jackson

Kingsport

Knoxville

Nashville

Austin

Carrollton

Dallas

Houston

San Antonio

Arlington

Chesapeake

Seattle

Spokane

Beckley

Clarksburg

Glendale

Vienna

Brussels

Genk

Ghent

Liège

Merksem

Edmonton

Kelowna

Vancouver

Winnipeg

Hamilton

Montreal

Québec

St. Johns

Hamburg

Herne

München

Ratingen

Heraklion- Crete

Thessalonikis

Stockholm

Cannock

Leeds

London

Manchester

Merseyside

Newcastle upon Tyne

Wigan

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Janssen Biotech, Inc.

INDUSTRY

NCT01004432 - Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) | Biotech Hunter | Biotech Hunter