The purpose of this research study is to observe the safety (freedom of harmful side effects) of MRA (investigational drug, tocilizumab). This study will also look at the effectiveness of MRA and methotrexate in reducing signs and symptoms of rheumatoid arthritis. 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 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
• Before selection and assignment to a treatment group patients must discontinue etanercept infliximab or adalimumab, anakinra, leflunomide according to guidelines outlined in the study
• Patients must receive methotrexate (MTX) for at least 12 weeks immediately prior to baseline, according to guidelines outlined in 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 (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 weighing more than 331 pounds
• History of severe allergy to any drugs used in the study

Please reference Study ID Number: PDO-WA17822      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Argentina
      Buenos Aires,  C1428CQG,  Argentina; Not yet recruiting
      Buenos Aires,  1431,  Argentina; Not yet recruiting
      Buenos Aires,  C1013AAR,  Argentina; Not yet recruiting
      Buenos Aires,  1405,  Argentina; Not yet recruiting
Australia
      Perth,  6008,  Australia; Recruiting
      COTTONTREE,  4558,  Australia; Recruiting
      Daw Park,  5041,  Australia; Not yet recruiting
      Douglas,  4184,  Australia; Recruiting
Austria
      Wien,  1090,  Austria; Recruiting
      Wien,  1160,  Austria; Recruiting
      Wien,  1130,  Austria; Recruiting
Brazil
      Sao Paulo,  05651-901,  Brazil; Not yet recruiting
      Porto Alegre,  91350-200,  Brazil; Not yet recruiting
Bulgaria
      Sofia,  1784,  Bulgaria; Not yet recruiting
      Sofia,  1606,  Bulgaria; Not yet recruiting
      Varna,  9010,  Bulgaria; Not yet recruiting
Canada, Alberta
      Calgary,  Alberta,  T2N 4N1,  Canada; Not yet recruiting
Canada, British Columbia
      Vancouver,  British Columbia,  V5Z 1L7,  Canada; Recruiting
      Victoria,  British Columbia,  V8V 3P9,  Canada; Recruiting
Canada, Ontario
      Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
      Ottawa,  Ontario,  K1H 7W9,  Canada; Not yet recruiting
      Newmarket,  Ontario,  L3Y 3R7,  Canada; Recruiting
Canada, Quebec
      Montreal,  Quebec,  H2L 1S6,  Canada; Recruiting
      Montreal,  Quebec,  H1T 4B3,  Canada; Not yet recruiting
      Sainte-Foy,  Quebec,  G1W 4R4,  Canada; Recruiting
China
      Hong Kong,  China; Not yet recruiting
France
      Paris,  75010,  France; Recruiting
      Paris,  75674,  France; Recruiting
      Paris,  75679,  France; Recruiting
      Paris,  75012,  France; Recruiting
      Besancon,  25030,  France; Recruiting
      Montpellier,  34295,  France; Not yet recruiting
      Tours,  37044,  France; Not yet recruiting
      Creteil,  94010,  France; Recruiting
Germany
      Tuebingen,  72076,  Germany; Not yet recruiting
      Berlin,  14059,  Germany; Not yet recruiting
      Erlangen,  91056,  Germany; Not yet recruiting
      Koeln,  50931,  Germany; Recruiting
      Heidelberg,  69120,  Germany; Not yet recruiting
      BADEN-BADEN,  76530,  Germany; Not yet recruiting
      BAD BRAMSTEDT,  24576,  Germany; Not yet recruiting
      Bad Nauheim,  61231,  Germany; Not yet recruiting
Hungary
      Pecs,  7621,  Hungary; Not yet recruiting
      Debrecen,  4004,  Hungary; Not yet recruiting
      Budapest,  1023,  Hungary; Not yet recruiting
Israel
      Haifa,  31096,  Israel; Not yet recruiting
      Haifa,  31048,  Israel; Not yet recruiting
      Tel Aviv,  64239,  Israel; Not yet recruiting
      Jerusalem,  91120,  Israel; Not yet recruiting
      Beer-Sheva,  84101,  Israel; Not yet recruiting
      Petach Tikva,  49100,  Israel; Not yet recruiting
Italy
      Modena,  41100,  Italy; Not yet recruiting
      Udine,  33100,  Italy; Not yet recruiting
      Siena,  53100,  Italy; Recruiting
      Palermo,  90127,  Italy; Not yet recruiting
      Gazzi,  98125,  Italy; Not yet recruiting
      Ferrara,  44100,  Italy; Not yet recruiting
Mexico
      Mexico City,  14000,  Mexico; Not yet recruiting
      Mexico City,  07760,  Mexico; Not yet recruiting
      Mexico City,  14389,  Mexico; Terminated
      Guadalajara,  44620,  Mexico; Not yet recruiting
      Guadalajara,  44690,  Mexico; Not yet recruiting
      San Luis Potosi,  78240,  Mexico; Not yet recruiting
Singapore
      Singapore,  119074,  Singapore; Not yet recruiting
      Singapore,  258499,  Singapore; Not yet recruiting
Slovakia
      PIESTANY,  92101,  Slovakia; Not yet recruiting
Spain
      Madrid,  28034,  Spain; Not yet recruiting
      Madrid,  28007,  Spain; Not yet recruiting
      Madrid,  28006,  Spain; Not yet recruiting
      Madrid,  28040,  Spain; Not yet recruiting
      Barcelona,  08003,  Spain; Not yet recruiting
      Oviedo,  33006,  Spain; Not yet recruiting
      Zaragoza,  50009,  Spain; Not yet recruiting
      SANTIAGO DE LA COMPOSTELA,  15706,  Spain; Not yet recruiting
      DONOSTIA,  Spain; Not yet recruiting
Switzerland
      Lausanne,  1011,  Switzerland; Recruiting
      Bern,  3010,  Switzerland; Recruiting
      MEYRIN,  1217,  Switzerland; Completed
      St. Gallen,  9007,  Switzerland; Recruiting
Thailand
      Bangkok,  10400,  Thailand; Not yet recruiting
      Bangkok,  10700,  Thailand; Not yet recruiting
      Chiang Mai,  50002,  Thailand; Not yet recruiting
United Kingdom
      Maidenhead,  SL6 1QZ,  United Kingdom; Completed
      Bathgate,  EH48 2EH,  United Kingdom; Completed

Study ID Numbers:  WA17822
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 25, 2005
ClinicalTrials.gov Identifier:  NCT00106548
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08