This study is for patients with active rheumatoid arthritis (RA) of at least 3 months duration, who have not been treated with methotrexate (MTX) within 6 months of being assigned to a treatment group, and who have not stopped MTX due to severe side effects or due to lack of response. Safety (freedom of harmful side effects) of MRA (investigational drug, tocilizumab) alone, compared to MTX alone, will be studied. This study will also look at the effectiveness of MRA compared to MTX. Patients will be randomly assigned (by chance) to three groups. Group A will receive MRA plus a MTX placebo (has appearance of drug, but no active drug). Group B will receive MTX plus MRA placebo. Group C will receive MRA placebo and MTX placebo for the first eight weeks of the study. Group C will then be given MRA for the remaining 4 months of the study.

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 3 months or longer
• Patients who are receiving treatment as an outpatient (not in the hospital)
• All DMARDS (disease-modifying anti-rheumatic drugs) used to treat RA stopped before entry into the study
• Patients taking oral corticosteroids and NSAIDS may be eligible if the dose is within a certain range and has been stable for at least 6 weeks prior to baseline
• Before selection and assignment to a treatment group for this study, patient must have stopped taking etanercept, infliximab or adalimumab (anti-TNF drug therapy), anakinra, and leflunomide according to the guidelines of the study
• 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

Exclusion Criteria:

• Patients who have had major surgery (including joint surgery) within 8 weeks prior to screening
• Patients who plan to have surgery within six months following assignment to one of the treatment groups
• Patients with rheumatic autoimmune disease other than rheumatoid arthritis (RA), including Systemic Lupus Erythematosus, Mixed Connective Tissue Disease (MCTD), or scleroderma (patients with Sjögren’s Syndrome and RA are eligible)
• Patients with prior or current history of inflammatory joint disease other than RA including gout, reactive arthritis, psoriatic arthritis, and Lyme disease
• Patients treated with MTX within 6 months prior to being assigned to one of the treatment groups
• Patients who have discontinued previous MTX treatment as result of severe side effects or lack of response
• Patients who did not respond to treatment with Anti-TNF (class of drugs to treat RA)
• Patients who have had corticosteroids injected into the joints or by intravenous injection (IV) within 6 weeks of start of study
• Treatment with any investigational agent within 4 weeks of screening
• Patients with certain serious uncontrolled diseases of the heart, lung, kidney, and liver
• Patients with uncontrolled diabetes mellitus
• Patients with history of severe allergic reactions to the type of drugs used in the study
• Patients with 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 refer to this study by ClinicalTrials.gov identifier  NCT00109408

Please reference Study ID Number: PDO-WA17824      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Montgomery,  Alabama,  36111,  United States
Arizona
      Phoenix,  Arizona,  85012,  United States
      Phoenix,  Arizona,  85013,  United States
Arkansas
      Hot Springs,  Arkansas,  71913,  United States
      Little Rock,  Arkansas,  72205,  United States
California
      Sacramento,  California,  95825,  United States
      San Leandro,  California,  94578,  United States
      Long Beach,  California,  90802,  United States
      Palm Springs,  California,  92262,  United States
Colorado
      Pueblo,  Colorado,  81008,  United States
Florida
      Tampa,  Florida,  33609,  United States
      Gainesville,  Florida,  32605,  United States
      Miami,  Florida,  33176,  United States
      Jupiter,  Florida,  33458,  United States
      Port Orange,  Florida,  32127,  United States
      Palm Harbor,  Florida,  34684,  United States
Idaho
      Idaho Falls,  Idaho,  83401,  United States
Illinois
      Springfield,  Illinois,  62704,  United States
      Morton Grove,  Illinois,  60053,  United States
Indiana
      Indianapolis,  Indiana,  46202,  United States
Iowa
      Des Moines,  Iowa,  50322,  United States
      Cedar Rapids,  Iowa,  52401,  United States
Kansas
      Mission,  Kansas,  66202,  United States
Louisiana
      Slidell,  Louisiana,  70458,  United States
Maryland
      Greenbelt,  Maryland,  20770,  United States
Massachusetts
      Pittsfield,  Massachusetts,  01201,  United States
Michigan
      Kalamazoo,  Michigan,  49048,  United States
      Grand Rapids,  Michigan,  49546,  United States
      PETOSKY,  Michigan,  49770,  United States
Minnesota
      Edina,  Minnesota,  55435,  United States
      St. Cloud,  Minnesota,  56303,  United States
Mississippi
      Tupelo,  Mississippi,  38802,  United States
      Jackson,  Mississippi,  39216,  United States
Missouri
      St. Louis,  Missouri,  63117,  United States
Nebraska
      Lincoln,  Nebraska,  68516,  United States
New Hampshire
      Nashua,  New Hampshire,  03060,  United States
      Dover,  New Hampshire,  03820,  United States
New Jersey
      New Brunswick,  New Jersey,  08903,  United States
New York
      Syracuse,  New York,  13210,  United States
North Carolina
      Hickory,  North Carolina,  28601,  United States
      Fayetteville,  North Carolina,  28304,  United States
Ohio
      Canton,  Ohio,  44718,  United States
      Mayfield,  Ohio,  44143,  United States
Oklahoma
      Tulsa,  Oklahoma,  74114,  United States
      Oklahoma City,  Oklahoma,  73139,  United States
      Oklahoma City,  Oklahoma,  73109,  United States
      Oklahoma City,  Oklahoma,  73112,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19104-5192,  United States
      Duncansville,  Pennsylvania,  16635,  United States
      West Reading,  Pennsylvania,  19611,  United States
      Willow Grove,  Pennsylvania,  19090,  United States
      Wynnewood,  Pennsylvania,  19096,  United States
South Carolina
      Columbia,  South Carolina,  29204,  United States
      Greenville,  South Carolina,  29601,  United States
Tennessee
      Nashville,  Tennessee,  37202,  United States
      Chattanooga,  Tennessee,  37404-1103,  United States
Texas
      Austin,  Texas,  78705,  United States
      Amarillo,  Texas,  79124,  United States
Virginia
      Arlington,  Virginia,  22204,  United States
Washington
      Spokane,  Washington,  99204-2336,  United States
      Yakima,  Washington,  98902,  United States
      Seattle,  Washington,  98133,  United States
Australia
      Perth,  6008,  Australia
      Sydney,  2050,  Australia
      Woodville,  5011,  Australia
      Daw Park,  5041,  Australia
      Woolloongabba,  4102,  Australia
      Hobart,  7000,  Australia
Croatia
      Zagreb,  10000,  Croatia
Denmark
      Herlev,  2730,  Denmark
France
      Paris,  75674,  France
      Paris,  75679,  France
      Lyon,  69000,  France
      Rouen,  76031,  France
      Brest,  29609,  France
Israel
      Beer-Sheva,  84101,  Israel
      RAMAT-GAN,  52621,  Israel
      Kfar Saba,  Israel
      Haifa,  31096,  Israel
      Ashkelon,  78306,  Israel
      RISHON LEZION,  Israel
Italy
      Pavia,  27100,  Italy
      Genova,  16132,  Italy
      Milano,  20157,  Italy
      Siena,  53100,  Italy
      REGGIO EMILIA,  42100,  Italy
Lithuania
      Siauliai,  76231,  Lithuania
      Kaunas,  LT-50009,  Lithuania
      Vilnius,  Lithuania
Mexico
      Mexico City,  14050,  Mexico
      Guadalajara,  44620,  Mexico
Portugal
      Lisboa,  1349-019,  Portugal
      Lisboa,  1649-035,  Portugal
      Lisboa,  1249-075,  Portugal
      PRAGAL-ALMADA,  2800-525,  Portugal
Slovenia
      LJUBLJANA,  1000,  Slovenia
      MARIBOR,  2000,  Slovenia
South Africa
      Soweto,  South Africa
      Johannesburg,  7500,  South Africa
      Cape Town,  7500,  South Africa
      Cape Town,  4001,  South Africa
      PINELANDS,  South Africa
Spain
      Barcelona,  08035,  Spain
      Cordoba,  14004,  Spain
      Alcorcon,  28922,  Spain
      Guadalajara,  19002,  Spain
      La Laguna,  38320,  Spain
      Lugo,  27004,  Spain
Yugoslavia
      BELGRADE,  11000,  Yugoslavia
      NISKA BANJA,  18250,  Yugoslavia

Study ID Numbers:  WA17824
Record last reviewed:  April 2005
Last Updated:  April 27, 2005
Record first received:  April 27, 2005
ClinicalTrials.gov Identifier:  NCT00109408
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03