NCT00487825 - Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions

Rheumatoid Arthritis

Interventions

DRUG

Canakinumab (investigational)

Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.

DRUG

Placebo

Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.

DRUG

Methotrexate (MTX)

Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.

Trial Locations (22)

22205

Arthritis Clinic of Northern Virginia (Dr. Philip Kempf), Arlington

32216

Jacksonville Center for Clinical Research (Dr. Steven Mathews), Jacksonville

33143

Center for Arthritis and Rheumatic Diseases (Dr. Michael Weitz), South Miami

33321

West Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert), Tamarac

35406

Clinic for Rheumatic Diseases (Dr. Richard Jones, III), Tuscaloosa

35801

Rheumatology Associates of Northern Alabama (Dr. William Shergy), Huntsville

50322

Mercy Arthritis and Osteoporosis Center (Dr. Alan Braun), Urbandale

61107

Rockford Orthopedic Associates (Dr. Richard Olson), Rockford

63117

Clayton Medical Research (Dr. Iri Don), Richmond Heights

68114

Westroads Medical Group (Dr. William Palmer), Omaha

74104

Oklahoma Center for Arthritis therapy and Research (Dr. James McKay), Tulsa

75007

John M. Joseph, MD (Dr. John Joseph), Carlton

75150

Southwest Rheumatology, P.A. (Dr. Atul Singhal), Mesquite

78704

MetaClin Research, Incorporated (Dr. Paul Pickrell), Austin

85253

Arizona Arthritis and Rheumatology Research (Dr. Paul Caldron), Paradise Valley

89502

Arthritis Center of Reno (Dr. Malin Prupas), Reno

99204

Arthritis Northwest Rheumatology, PLLC (Dr. Jeffrey Butler), Spokane

Unknown

Novartis Investigative site, Brussels

Novartis investigative site, Nuremberg

Novartis investigative site, Milan

Novartis Investigative site, Arnhem

Novartis investigative site, Barcelona