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Trial information
An Extension Study of Tocilizumab in Patients Completing Treatment in Tocilizumab Core Studies
Status: No longer recruiting
Protocol number: WA18696
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: Long-term extension study of safety during treatment with tocilizumab in rheumatoid arthritis patients completing treatment in tocilizumab core studies WA18062, WA18063 and WA17824
Brief summary: This single arm study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab core studies of adults with rheumatoid arthritis. Patients will receive tocilizumab alone or in combination with standard anti-rheumatic treatment. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
Target sample size is
2068.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: tocilizumab
Primary outcome: 1. Efficacy: Concomitant corticosteroid treatment; proportion of patients with ACR20/50/70 response; individual components of the ACR core set; withdrawals from treatment. Time frame: Every 12 weeks
2. Change in DAS28; categorical DAS responders; maintenance of ACR20/50/70 response. Time frame: 24, 48, 96, 264 weeks.
Key secondary outcomes: 1. Quality of life: The HAQ, SF 36, EQ-5D, FACIT fatigue scale
Time frame: Every 12 weeks
2. Safety: AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria: - patients who have completed participation in one of the core studies in adult rheumatoid arthritis.
Exclusion criteria: - treatment with any investigational agent since the last administration of study drug in core studies;
- treatment with iv gamma globulin, plasmapheresis or prosorba column since the last administration of study drug in core studies;
- treatment with an anti-TNF or anti-IL1 agent, or a T-cell costimulation modulator or any biologic since the last administration of study drug in core studies;
- previous treatment with any cell-depleting therapies, including investigational agents;
- parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18696.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2005
Trial registration date: 12/12/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:Argentina Australia - Hobart
- Malvern
- Shenton Park
- Sydney
- Woolloongabba
Belgium Brazil - Campinas
- Goiania
- Rio De Janeiro
Canada - Calgary, AB
- Edmonton, AB
- Victoria, BC
- Winnipeg, MB
- St John'S
- Burlington, ON
- Hamilton, ON
- Kitchener, ON
- London, ON
- Mississauga, ON
- Ottawa, ON
- Toronto, ON
- Montreal, QC
- Quebec City, QC
- Sainte-Foy, QC
- Saskatoon, SK
China - Beijing
- Guangzhou
- Hefei Anhui
- Hong Kong
- Jinan
- Shanghai
- Tuen Mun
Costa Rica Czech Republic Denmark Finland France - Amiens
- Bordeaux
- Boulogne-Billancourt
- Brest
- Grenoble
- Le Kremlin-Bicetre
- Lille
- Lyon
- Marseille
- Montpellier
- Nantes
- Nice
- Paris
- Pierre Benite
- Rennes
- Rouen
- Saint-Etienne
- Strasbourg
- Toulouse
Germany - Aachen
- Berlin
- Dresden
- Essen
- Herne
- Hildesheim
- Köln
- München
- Osnabrück
- Sendenhorst
- Vogelsang-Gommern
- Würzburg
Iceland Israel - Ashkelon
- Haifa
- Rishon Lezion
Italy - Brescia
- Genova
- Milano
- Padova
- Pavia
- Pisa
- Udine
Lithuania - Kaunas
- Klaipeda
- Panevezys
- Siauliai
- Vilnius
Mexico - Guadalajara
- Leon
- Mexico City
- Tijuana
Netherlands Norway Panama Peru Portugal Russian Federation - Moscow
- Ryazan
- St Petersburg
- Tula
Slovenia South Africa - Cape Town
- Durban
- Pinelands
- Pretoria
- Radiokop
- Soweto
Spain - Barakaldo
- Barcelona
- Madrid
- Malaga
- Pontevedra
- Santiago de Compostela
Sweden Switzerland Thailand United Kingdom - Basingstoke
- Birmingham
- Derby
- Leeds
- London
- Manchester
- Middlesborough
- Newcastle upon Tyne
- Oxford
- Southampton
- Stoke-on-Trent
United States - Birmingham, AL
- Huntsville, AL
- Paradise Valley, AZ
- Peoria, AZ
- Phoenix, AZ
- Scottsdale, AZ
- Tucson , AZ
- Little Rock, AR
- Long Beach, CA
- Los Angeles, CA
- Palm Desert, CA
- Palm Springs, CA
- Palo Alto, CA
- San Diego , CA
- San Jose, CA
- San Leandro, CA
- Upland, CA
- Aurora, CO
- Colorado Springs, CO
- Newark, DE
- Aventura, FL
- Delray Beach, FL
- Fort Lauderdale, FL
- Jacksonville, FL
- Palm Harbor, FL
- Sarasota , FL
- Tampa, FL
- Atlanta, GA
- Boise, ID
- Idaho Falls, ID
- Meridan, ID
- Morton Grove, IL
- Springfield, IL
- Vernon Hills, IL
- Indianapolis , IN
- Cedar Rapids, IA
- Des Moines, IA
- Bowling Green, KY
- Lexington, KY
- Louisville, KY
- Baton Rouge, LA
- Shreveport, LA
- Portland, ME
- Frederick, MD
- Wheaton, MD
- Pittsfield, MA
- Worcester, MA
- Grand Rapids, MI
- Kalamazoo, MI
- Lansing, MI
- Royal Oak, MI
- Eagan, MN
- Minneapolis, MN
- St Cloud, MN
- Flowood, MS
- Tupelo, MS
- Springfield, MO
- St Louis, MO
- Billings, MT
- Lincoln, NE
- Reno , NV
- Dover, NH
- Haddon Heights, NJ
- New Brunswick, NJ
- Passaic, NJ
- Albuquerque, NM
- Albany, NY
- Binghamton, NY
- Lake Success, NY
- New York, NY
- Orchard Park, NY
- Plainview, NY
- Syracuse, NY
- Asheville, NC
- Chapel Hill, NC
- Charlotte, NC
- Durham, NC
- Hickory , NC
- Raleigh, NC
- Wilmington, NC
- Beachwood, OH
- Cincinnati, OH
- Dayton, OH
- Oklahoma City, OK
- Tulsa , OK
- Eugene, OR
- Allentown, PA
- Bethlehem, PA
- Danville, PA
- Duncansville, PA
- Philadelphia, PA
- Pittsburgh, PA
- West Reading, PA
- Willow Grove, PA
- Ponce, PR
- Johnston, RI
- Charleston, SC
- Columbia, SC
- Greenville, SC
- Hixson, TN
- Jackson, TN
- Nashville, TN
- Amarillo, TX
- Austin, TX
- Dallas, TX
- Houston, TX
- Mesquite, TX
- Burlington, VT
- Chesapeake, VA
- Norfolk , VA
- Mountlake Terrace, WA
- Olympia, WA
- Seattle, WA
- Spokane , WA
- Tacoma, WA
- Glendale, WI
- La Crosse, WI
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