This study is for patients with rheumatoid arthritis who did not respond to specific drugs currently used to treat rheumatoid arthritis known as DMARDs (disease-modifying anti-rheumatic drugs). This study will look at safety (free of harmful side effects) of MRA (tocilizumab), an investigational drug, in combination with DMARD therapy. This study will also look to see if there is a reduction of signs and symptoms of rheumatoid arthritis in patients receiving MRA in combination with DMARD therapy. Patients in this study will be randomly (by chance) assigned to 2 groups. One group will receive MRA along with DMARD therapy and the other group will receive placebo (has appearance of drug, but no active drug) along with DMARD therapy.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: Tocilizumab (International Nonproprietary Name, INN)	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 18 years and older
• Patients able and willing to give written informed consent
• Patients who have had rheumatoid arthritis (RA) for at least 6 months or longer
• Patients who are receiving treatment as an outpatient (not in the hospital)
• Females who can become pregnant and males with female partners who can become pregnant that are able and willing to use reliable means of contraception (birth control pill or birth control patch, spermicide and barrier (condom), or intrauterine device (IUD)
• Females who can become pregnant must have a negative urine pregnancy test within three weeks prior to beginning the study
• Patients who received permitted DMARDs (disease-modifying anti-rheumatic drugs used to treat RA) for at least 8 weeks
• Patients taking oral corticosteroids and NSAIDs (Nonsteroidal Anti-Inflammatory drugs) may be eligible if the dose is within certain range and has been stable for at least 6 weeks before start of study

Exclusion Criteria:

• Patients having major surgery (including joint surgery) within eight weeks prior to screening
• Patients who plan to have surgery within six months following assignment to one of the study treatment groups
• Patients with rheumatic autoimmune disease other than rheumatoid arthritis (RA), including Systemic Lupus Erythematosus, Mixed Connective Tissue Disease (MCTD), scleroderma, polymyositis (patients with Sjögren’s Syndrome and RA are eligible)
• Patients with certain serious uncontrolled diseases of the heart, lung, kidney, and liver
• Patients with uncontrolled diabetes mellitus
• Uncontrolled diseases, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with corticosteroids
• Patients with current or past history of certain types of infections including hepatitis B, hepatitis C, and shingles
• Patients with current or past condition resulting in decreased ability of the body to fight infection and disease (immunodeficiency)
• Patients with a history of cancer except for basal cell carcinoma (a type of skin cancer) that has been treated and cured
• Pregnant women or women who are breast feeding
• Patients with a history of alcohol, drug or chemical abuse within the six months prior to screening
• Patients weighing more than 331 pounds

Please reference Study ID Number: PDO-WA18063      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Arizona
      Scottsdale,  Arizona,  85258,  United States
      Tucson,  Arizona,  85723,  United States
      Glendale,  Arizona,  85308,  United States
      Phoenix,  Arizona,  85012,  United States
      Paradise Valley,  Arizona,  85253,  United States
Arkansas
      Little Rock,  Arkansas,  72205,  United States
California
      Los Angeles,  California,  90048,  United States
      San Jose,  California,  95126,  United States
      Palo Alto,  California,  94304,  United States
      Upland,  California,  91786,  United States
      Palm Desert,  California,  92260,  United States
Connecticut
      Danbury,  Connecticut,  06810,  United States
Delaware
      Newark,  Delaware,  19713,  United States
District of Columbia
      Washington,  District of Columbia,  20006,  United States
Florida
      Delray Beach,  Florida,  33484,  United States
      Palm Harbor,  Florida,  34684,  United States
Georgia
      Cartersville,  Georgia,  30120,  United States
      Rome,  Georgia,  30165,  United States
Illinois
      Chicago,  Illinois,  60611,  United States
      Chicago,  Illinois,  60637,  United States
      Springfield,  Illinois,  62704,  United States
      Vernon Hills,  Illinois,  60061,  United States
Indiana
      Indianapolis,  Indiana,  46202,  United States
      Indianapolis,  Indiana,  46214-2985,  United States
Kansas
      Wichita,  Kansas,  67208,  United States
      Overland Park,  Kansas,  66210,  United States
Kentucky
      Bowling Green,  Kentucky,  42102,  United States
Louisiana
      Shreveport,  Louisiana,  71130,  United States
      Baton Rouge,  Louisiana,  70808,  United States
Maine
      Portland,  Maine,  04102,  United States
Maryland
      Frederick,  Maryland,  21702,  United States
Massachusetts
      Boston,  Massachusetts,  02215,  United States
      Boston,  Massachusetts,  02111,  United States
      Worcester,  Massachusetts,  01610,  United States
      Newton,  Massachusetts,  02464,  United States
Michigan
      Lansing,  Michigan,  48910,  United States
Minnesota
      Minneapolis,  Minnesota,  55416,  United States
      Duluth,  Minnesota,  55805,  United States
Missouri
      St. Louis,  Missouri,  63117,  United States
      Springfield,  Missouri,  65807,  United States
Nebraska
      Lincoln,  Nebraska,  68506,  United States
Nevada
      Reno,  Nevada,  89502,  United States
New Jersey
      Livingston,  New Jersey,  07039,  United States
      New Brunswick,  New Jersey,  08903,  United States
      Haddon Heights,  New Jersey,  08035,  United States
      Passaic,  New Jersey,  07055,  United States
New Mexico
      Albuquerque,  New Mexico,  87131,  United States
New York
      New York,  New York,  10021,  United States
      Syracuse,  New York,  13210,  United States
      Plainview,  New York,  11803,  United States
      Roslyn,  New York,  11576,  United States
      Smithtown,  New York,  11787,  United States
North Carolina
      Winston Salem,  North Carolina,  27157,  United States
      Raleigh,  North Carolina,  27609,  United States
      Charleston,  North Carolina,  29406,  United States
      Durham,  North Carolina,  27704,  United States
      Gastonia,  North Carolina,  28054,  United States
Ohio
      Cincinnati,  Ohio,  45245,  United States
      Gallipolis,  Ohio,  45631,  United States
      Beachwood,  Ohio,  44122,  United States
      Dayton,  Ohio,  45402,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73139,  United States
      Oklahoma City,  Oklahoma,  73112,  United States
      Tulsa,  Oklahoma,  74114,  United States
Oregon
      Medford,  Oregon,  97504,  United States
Pennsylvania
      Allentown,  Pennsylvania,  18103,  United States
      Colmar,  Pennsylvania,  18915,  United States
      Philadelphia,  Pennsylvania,  19104-5192,  United States
      Pittsburgh,  Pennsylvania,  15261,  United States
      Bethlehem,  Pennsylvania,  18015,  United States
      Yardley,  Pennsylvania,  19067,  United States
      Willow Grove,  Pennsylvania,  19090,  United States
      Rockledge,  Pennsylvania,  19046,  United States
Rhode Island
      Johnston,  Rhode Island,  02919,  United States
Tennessee
      Nashville,  Tennessee,  37203,  United States
      Chattanooga,  Tennessee,  37404-1103,  United States
Texas
      Austin,  Texas,  78705,  United States
      Houston,  Texas,  77074,  United States
      Mesquite,  Texas,  75150,  United States
Vermont
      Burlington,  Vermont,  05405,  United States
Virginia
      Arlington,  Virginia,  22204,  United States
Washington
      Vancouver,  Washington,  98664,  United States
      Seattle,  Washington,  98101,  United States
      Tacoma,  Washington,  98405,  United States
Wisconsin
      La Crosse,  Wisconsin,  54601,  United States
      Milwaukee,  Wisconsin,  53226,  United States
Argentina
      Rosario,  2000,  Argentina
      Buenos Aires,  C1428CQG,  Argentina
      Buenos Aires,  C1013AAR,  Argentina
Australia
      Sydney,  2050,  Australia
      Parkville,  3050,  Australia
Brazil
      Rio de Janeiro,  20551-030,  Brazil
      Campinas,  13059-740,  Brazil
      Goiania,  74605-050,  Brazil
Canada, Manitoba
      Winnipeg,  Manitoba,  R3A 1M3,  Canada
Canada, Ontario
      Ottawa,  Ontario,  K1H 1A2,  Canada
      Hamilton,  Ontario,  L8N 2B6,  Canada
Canada, Quebec
      Sainte-Foy,  Quebec,  G1V 3M7,  Canada
Canada, Saskatchewan
      Saskatoon,  Saskatchewan,  S7N 0W8,  Canada
China
      Shanghai,  China
      Beijing,  China
      Hong Kong,  China
      TUEN MUN,  852,  China
Costa Rica
      San Jose,  Costa Rica
Czech Republic
      Praha,  128 50,  Czech Republic
      Praha,  140 59,  Czech Republic
      HRADEC KRALOVE,  50005,  Czech Republic
Finland
      Helsinki,  00280,  Finland
      JYVAESKYLAE,  40620,  Finland
France
      Nantes,  44035,  France
      Montpellier,  34295,  France
      Limoges,  87042,  France
      Grenoble,  38042,  France
      Pierre-Benite,  69495,  France
      Boulogne-Billancourt,  92104,  France
      Marseille,  13285,  France
      Clermont-Ferrand,  63003,  France
      Saint-Etienne,  4200,  France
      Rennes,  35056,  France
Germany
      Muenchen,  80335,  Germany
      Stuttgart,  70469,  Germany
      ESSEN,  45239,  Germany
      SENDENHORST,  48324,  Germany
      Aachen,  52064,  Germany
      Hildesheim,  31134,  Germany
Mexico
      Leon,  37000,  Mexico
      Mexico City,  14050,  Mexico
      Mexico City,  07760,  Mexico
      Tijuana,  22320,  Mexico
Panama
      Panama City,  2745,  Panama
Russian Federation
      Moscow,  117049,  Russian Federation
      Moscow,  115522,  Russian Federation
      St Petersburg,  190068,  Russian Federation
      St Petersburg,  191015,  Russian Federation
South Africa
      Durban,  4001,  South Africa
      Pretoria,  South Africa
      ROODEPORT,  South Africa
Spain
      Madrid,  28040,  Spain
      Malaga,  29010,  Spain
      Pontevedra,  36001,  Spain
      Barakaldo,  48903,  Spain
      Gijon,  33006,  Spain
Sweden
      Umea,  90185,  Sweden
      Stockholm,  171 76,  Sweden
      GOETEBORG,  413 45,  Sweden
Thailand
      Bangkok,  10400,  Thailand
      Bangkok,  10330,  Thailand
      Chiang Mai,  50002,  Thailand

Study ID Numbers:  WA18063
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 25, 2005
ClinicalTrials.gov Identifier:  NCT00106574
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08