The purpose of this study is to see if MRA (tocilizumab), an investigational drug combined with methotrexate, can reduce the signs and symptoms of rheumatoid arthritis, prevent joint damage, and improve physical function. Another purpose of this study is to determine the safety (free of harmful side effects) of MRA combined with methotrexate. Patients will be assigned randomly (by chance) to three groups. Patients in all three groups will receive methotrexate. Patients in two of the three groups will receive the investigational drug, MRA, and the third group with receive a placebo (has the appearance of drug, but no active drug).

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 able and willing to follow the requirements of the study
• 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), each at a stable dose, 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
• Must be willing to take folate (a B vitamin) by mouth

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 (patient with Sjögren’s Syndrome and RA is 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 with painful conditions that will make it hard to assess their pain
• Patients weighing more than 331 pounds
• History of severe allergy to any drugs used in the study

Please reference Study ID Number: PDO-WA17823      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35233,  United States; Not yet recruiting
      Huntsville,  Alabama,  35801,  United States; Recruiting
Arizona
      Scottsdale,  Arizona,  85251,  United States; Recruiting
      Tucson,  Arizona,  85724,  United States; Not yet recruiting
California
      Los Angeles,  California,  90095,  United States; Not yet recruiting
      San Francisco,  California,  94118,  United States; Recruiting
      Torrance,  California,  90505,  United States; Recruiting
      Escondido,  California,  92025,  United States; Terminated
      Anaheim,  California,  92801,  United States; Not yet recruiting
Colorado
      Denver,  Colorado,  80230,  United States; Recruiting
      Boulder,  Colorado,  80304,  United States; Recruiting
Florida
      Tampa,  Florida,  33614,  United States; Recruiting
      Aventura,  Florida,  33180,  United States; Recruiting
      West Palm Beach,  Florida,  33407,  United States; Recruiting
Georgia
      Atlanta,  Georgia,  30342,  United States; Terminated
Idaho
      MERIDAN,  Idaho,  83642,  United States; Recruiting
      Boise,  Idaho,  83702,  United States; Recruiting
      Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Illinois
      Chicago,  Illinois,  60612-3824,  United States; Not yet recruiting
      Rockford,  Illinois,  61103,  United States; Not yet recruiting
Indiana
      Indianapolis,  Indiana,  46202-5100,  United States; Not yet recruiting
Kentucky
      Lexington,  Kentucky,  40515,  United States; Recruiting
Maryland
      Wheaton,  Maryland,  20902,  United States; Recruiting
Massachusetts
      Worcester,  Massachusetts,  01605,  United States; Recruiting
      Newton,  Massachusetts,  02464,  United States; Completed
Missouri
      St. Louis,  Missouri,  63141,  United States; Recruiting
      St. Louis,  Missouri,  63131,  United States; Recruiting
Montana
      Billings,  Montana,  59107-5100,  United States; Recruiting
      Missoula,  Montana,  59802,  United States; Recruiting
New Jersey
      Voorhees,  New Jersey,  08043,  United States; Recruiting
      Medford,  New Jersey,  08055,  United States; Recruiting
New York
      New York,  New York,  10003,  United States; Not yet recruiting
      Brooklyn,  New York,  11201,  United States; Recruiting
      Albany,  New York,  12206,  United States; Recruiting
      Manhasset,  New York,  11030,  United States; Not yet recruiting
      Stony Brook,  New York,  11794-8161,  United States; Recruiting
North Carolina
      Charlotte,  North Carolina,  28210,  United States; Recruiting
      Asheville,  North Carolina,  28801,  United States; Recruiting
      Wilmington,  North Carolina,  28401,  United States; Recruiting
Oklahoma
      Tulsa,  Oklahoma,  74135,  United States; Recruiting
Oregon
      Eugene,  Oregon,  97401,  United States; Recruiting
Pennsylvania
      Allentown,  Pennsylvania,  18106-9510,  United States; Completed
      Philadelphia,  Pennsylvania,  19140,  United States; Not yet recruiting
      Duncansville,  Pennsylvania,  16635,  United States; Recruiting
      Danville,  Pennsylvania,  17822,  United States; Recruiting
      Wyomissing,  Pennsylvania,  19610,  United States; Recruiting
Texas
      Dallas,  Texas,  75235,  United States; Recruiting
      San Antonio,  Texas,  78217,  United States; Recruiting
Washington
      Seattle,  Washington,  98101,  United States; Completed
      Seattle,  Washington,  98104,  United States; Not yet recruiting
      Olympia,  Washington,  98502,  United States; Recruiting
Wisconsin
      Glendale,  Wisconsin,  53217,  United States; Recruiting
Australia
      Clayton,  3168,  Australia; Not yet recruiting
      Sydney,  2139,  Australia; Not yet recruiting
      Woodville,  5011,  Australia; Not yet recruiting
      Newcastle,  2300,  Australia; Not yet recruiting
      Malvern,  3144,  Australia; Recruiting
Brazil
      Sao Paulo,  01221-020,  Brazil; Not yet recruiting
      Sao Paulo,  01246-903,  Brazil; Not yet recruiting
      Sao Paulo,  04026-000,  Brazil; Not yet recruiting
      Rio de Janeiro,  20551-030,  Brazil; Not yet recruiting
China
      Shanghai,  China; Not yet recruiting
      Beijing,  China; Not yet recruiting
      Nanjing,  China; Not yet recruiting
Denmark
      Odense,  5000,  Denmark; Not yet recruiting
      Herlev,  2730,  Denmark; Recruiting
Finland
      Oulu,  90029,  Finland; Not yet recruiting
      Helsinki,  FIN-00290,  Finland; Not yet recruiting
      Heinola,  18120,  Finland; Not yet recruiting
      VANTAA,  01400,  Finland; Not yet recruiting
France
      Toulouse,  31054,  France; Not yet recruiting
      Paris,  75651,  France; Not yet recruiting
      Paris,  75018,  France; Not yet recruiting
      Amiens,  80054,  France; Not yet recruiting
      Lille,  59037,  France; Not yet recruiting
      Kremlin-Bicetre,  94270,  France; Not yet recruiting
      Rouen,  76031,  France; Not yet recruiting
      Strasbourg,  67098,  France; Not yet recruiting
      Nice,  06202,  France; Not yet recruiting
      Bordeaux,  33076,  France; Not yet recruiting
      Bobigny,  93009,  France; Not yet recruiting
      Orleans,  45032,  France; Not yet recruiting
      Vandoeuvre-les-Nancy,  54511,  France; Not yet recruiting
Germany
      Hamburg,  20097,  Germany; Completed
Greece
      Athens,  Greece; Recruiting
      Athens,  11527,  Greece; Recruiting
      Athens,  15127,  Greece; Recruiting
Italy
      Pavia,  27100,  Italy; Not yet recruiting
      Roma,  00161,  Italy; Not yet recruiting
      Napoli,  80131,  Italy; Not yet recruiting
      Padova,  35128,  Italy; Not yet recruiting
      Genova,  16132,  Italy; Not yet recruiting
      Torino,  10100,  Italy; Not yet recruiting
      Milano,  20122,  Italy; Not yet recruiting
      Milano,  20157,  Italy; Not yet recruiting
      REGGIO EMILIA,  42100,  Italy; Not yet recruiting
      Udine,  33100,  Italy; Not yet recruiting
      Bari,  70124,  Italy; Not yet recruiting
      Brescia,  25123,  Italy; Not yet recruiting
      Firenze,  50139,  Italy; Not yet recruiting
      Pisa,  56127,  Italy; Recruiting
      Varese,  21100,  Italy; Not yet recruiting
      Valeggio,  37067,  Italy; Not yet recruiting
      Verona,  37134,  Italy; Not yet recruiting
Mexico
      Mexico City,  Mexico; Not yet recruiting
      Mexico City,  03100,  Mexico; Not yet recruiting
      Chihuahua,  31000,  Mexico; Not yet recruiting
      Monterrey,  64000,  Mexico; Not yet recruiting
      Ciudad Obregon,  85100,  Mexico; Not yet recruiting
      Monterrey Nuevo Leon,  64320,  Mexico; Not yet recruiting
Norway
      LILLEHAMMER,  2609,  Norway; Not yet recruiting
      TROMSOE,  9038,  Norway; Not yet recruiting
      HAUGESUND,  5528,  Norway; Not yet recruiting
Poland
      Warszawa,  00-909,  Poland; Not yet recruiting
      Warszawa,  02-637,  Poland; Not yet recruiting
      Krakow,  30-119,  Poland; Not yet recruiting
      Szczecin,  71-252,  Poland; Not yet recruiting
      DZIALDOWO,  13-200,  Poland; Not yet recruiting
      USTRON,  43-450,  Poland; Not yet recruiting
Puerto Rico
      San Juan,  00936-5067,  Puerto Rico; Not yet recruiting
South Africa
      Durban,  4001,  South Africa; Not yet recruiting
      Soweto,  South Africa; Not yet recruiting
      Cape Town,  4001,  South Africa; Not yet recruiting
      Cape Town,  7500,  South Africa; Not yet recruiting
      PINELANDS,  South Africa; Not yet recruiting
Spain
      Madrid,  28007,  Spain; Terminated
      Barcelona,  08036,  Spain; Not yet recruiting
      Barcelona,  08003,  Spain; Terminated
      Santander,  39008,  Spain; Not yet recruiting
      La Coruna,  15006,  Spain; Terminated
      Sevilla,  41071,  Spain; Not yet recruiting
      SANTIAGO DE LA COMPOSTELA,  15706,  Spain; Terminated
      Sabadell,  08208,  Spain; Not yet recruiting
Switzerland
      Lausanne,  1011,  Switzerland; Recruiting
      MEYRIN,  1217,  Switzerland; Completed
      St. Gallen,  9007,  Switzerland; Recruiting
United Kingdom
      Maidenhead,  SL6 1QZ,  United Kingdom; Completed
      Bathgate,  EH48 2EH,  United Kingdom; Completed

Study ID Numbers:  WA17823
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 25, 2005
ClinicalTrials.gov Identifier:  NCT00106535
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08