An Extension Study of Tocilizumab in Patients Completing Treatment in Tocilizumab Core Studies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00720798
First received: July 22, 2008
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Drug: Standard anti-rheumatic treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in DAS28; categorical DAS responders; maintenance of ACR20/50/70 response. [ Time Frame: 24, 48, 96, 264 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: The HAQ, SF 36, EQ-5D, FACIT fatigue scale\n [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 2068
Study Start Date: September 2005
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
iv 8mg/kg every 4 weeks
Drug: Standard anti-rheumatic treatment
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00720798

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Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-7201
Huntsville, Alabama, United States, 35801
United States, Arizona
Mesa, Arizona, United States, 85208
Paradise Valley, Arizona, United States, 85253
Peoria, Arizona, United States, 85381
Scottsdale, Arizona, United States, 85258
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85724
Tucson, Arizona, United States, 85723
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim, California, United States, 92801
Long Beach, California, United States, 90806
Long Beach, California, United States, 90808
Los Angeles, California, United States, 90045
Los Angeles, California, United States, 90095
Palm Desert, California, United States, 92260
Palm Springs, California, United States, 92262
Palo Alto, California, United States, 94304
San Diego, California, United States, 92101
San Diego, California, United States, 92108
San Jose, California, United States, 95126
San Leandro, California, United States, 94578
Santa Maria, California, United States, 93454
Torrance, California, United States, 90505
Upland, California, United States, 91786
United States, Colorado
Colorado Springs, Colorado, United States, 80910
United States, Delaware
Newark, Delaware, United States, 19713
United States, Florida
Aventura, Florida, United States, 33180
Delray Beach, Florida, United States, 33484
Fort Lauderdale, Florida, United States, 33334
Palm Habor, Florida, United States, 34684
Palm Harbor, Florida, United States, 34684
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33609
Tampa, Florida, United States, 33614
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Idaho
Boise, Idaho, United States, 83702
Idaho Falls, Idaho, United States, 83404
Meridian, Idaho, United States, 83642
United States, Illinois
Morton Grove, Illinois, United States, 60053
Springfield, Illinois, United States, 62704
Vernon Hills, Illinois, United States, 60061
United States, Indiana
Indianapolis, Indiana, United States, 46202-5149
United States, Iowa
Cedar Rapids, Iowa, United States, 52401
Des Moines, Iowa, United States, 50322
United States, Kentucky
Bowling Green, Kentucky, United States, 42102
Lexington, Kentucky, United States, 40515
Louisville, Kentucky, United States, 40202
United States, Louisiana
Baton Rouge, Louisiana, United States, 70808
Shreverport, Louisiana, United States, 71103
Slidell, Louisiana, United States, 70458
United States, Maine
Portland, Maine, United States, 04102
United States, Maryland
Frederick, Maryland, United States, 21702
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Grand Rapids, Michigan, United States, 49546
Kalamazoo, Michigan, United States, 49048
Lansing, Michigan, United States, 48910
United States, Minnesota
Eagan, Minnesota, United States, 55121
St Cloud, Minnesota, United States, 56303
St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
Flowood, Mississippi, United States, 39232
Tupelo, Mississippi, United States, 38802
United States, Missouri
Saint Louis, Missouri, United States, 63131
Saint Louis, Missouri, United States, 63128
Springfield, Missouri, United States, 65807
St Louis, Missouri, United States, 63117
St Louis, Missouri, United States, 63141
United States, Montana
Billings, Montana, United States, 59107-5100
United States, Nebraska
Lincoln, Nebraska, United States, 68516
United States, Nevada
Reno, Nevada, United States, 89502
United States, New Hampshire
Dover, New Hampshire, United States, 03820
United States, New Jersey
Haddon Heights, New Jersey, United States, 08035
New Brunswick, New Jersey, United States, 08903
Passaic, New Jersey, United States, 07055
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany, New York, United States, 12206
Binghamton, New York, United States, 13905
Great Neck, New York, United States, 11020
New York, New York, United States, 10021
Orchard Park, New York, United States, 14127
Plainview, New York, United States, 11803
Rochester, New York, United States, 14642
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28803
Chapel Hill, North Carolina, United States, 27599-7280
Charlotte, North Carolina, United States, 28210
Durham, North Carolina, United States, 27704
Raleigh, North Carolina, United States, 27609
United States, North Dakota
Bismarck, North Dakota, United States, 58501
United States, Ohio
Canton, Ohio, United States, 44718
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44109
Dayton, Ohio, United States, 45408
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Oklahoma City, Oklahoma, United States, 73109
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Eugene, Oregon, United States, 97401
Medford, Oregon, United States, 97504
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18103
Bethlehem, Pennsylvania, United States, 18015
Danville, Pennsylvania, United States, 17822
Duncansville, Pennsylvania, United States, 16635
Philadelphia, Pennsylvania, United States, 19152
Pittsburgh, Pennsylvania, United States, 15261
Willow Grove, Pennsylvania, United States, 80045
Willow Grove, Pennsylvania, United States, 19090
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Charleston, South Carolina, United States, 29406
Columbia, South Carolina, United States, 29204
Greenville, South Carolina, United States, 29601
Hickory, South Carolina, United States, 28602
United States, Tennessee
Hixson, Tennessee, United States, 37343
Jackson, Tennessee, United States, 38305
Nashville, Tennessee, United States, 37203
United States, Texas
Amarillo, Texas, United States, 79124
Austin, Texas, United States, 78749
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75231-4406
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77074
Mesquite, Texas, United States, 75150
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Chesapeake, Virginia, United States, 23320
Norfolk, Virginia, United States, 23502
United States, Washington
Mountlake Terrace, Washington, United States, 98043
Olympia, Washington, United States, 98502
Seattle, Washington, United States, 98104
Seattle, Washington, United States, 98195
Spokane, Washington, United States, 99204
Tacoma, Washington, United States, 98405
United States, Wisconsin
Glendale, Wisconsin, United States, 53217
Lacrosse, Wisconsin, United States, 54601
Argentina
Buenos Aires, Argentina, C1428DQG
Buenos Aires, Argentina, C1015ABO
Florencio Varela, Argentina, B1878DVB
Rosario, Argentina, S2000PBJ
Australia
Hobart, Australia, 7000
Malvern, Australia, 3144
Shenton Park, Australia, 6008
Sydney, Australia, 2050
Woolloongabba, Australia, 4102
Belgium
Hasselt, Belgium, 3500
Merksem, Belgium, 2170
Brazil
Campinas, Brazil, 13060-803
Goiania, Brazil, 74653-050
Rio de Janeiro, Brazil, 20551030
Canada, Alberta
Calgary, Alberta, Canada, T2V 1P9
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Burlington, Ontario, Canada, L7R 1E2
Hamilton, Ontario, Canada, L8N 2B6
Kitchener, Ontario, Canada, N2M 5N6
London, Ontario, Canada, N6A 4V2
Mississauga, Ontario, Canada, L5M 2V8
Ottawa, Ontario, Canada, K1H 1A2
Toronto, Ontario, Canada, M5T 3L9
Canada, Quebec
Montreal, Quebec, Canada, H2L 1S6
Quebec City, Quebec, Canada, G1V 3M7
Sainte-foy, Quebec, Canada, G1W 4R4
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
China
Beijing, China, 100044
Beijing, China, 100032
Guangzhou, China, 510630
Hefei Anhui, China, 230022
Jinan, China, 250012
Shanghai, China, 200433
Shanghai, China, 200127
Costa Rica
San Jose, Costa Rica, 10103
Czech Republic
Hradec Kralove, Czech Republic, 500 05
Praha, Czech Republic, 140 59
Praha, Czech Republic, 128 50
Denmark
Hellerup, Denmark, 2900
Finland
Helsinki, Finland, 00290
Jyväskylä, Finland, 40620
France
Amiens, France, 80054
Bordeaux, France, 33076
Boulogne-billancourt, France, 92104
Brest, France, 29609
Grenoble, France, 38042
Le Kremlin-bicetre, France, 94270
Lille, France, 59037
Lyon, France, 69437
Marseille, France, 13285
Montpellier, France, 34295
Nantes, France, 44035
Nice, France, 06202
Paris, France, 75679
Paris, France, 75181
Pierre Benite, France, 69495
Rennes, France, 35203
Rouen, France, 76031
St Priest En Jarez, France, 42277
Strasbourg, France, 67098
Toulouse, France, 31059
Germany
Aachen, Germany, 52064
Berlin, Germany, 10117
Dresden, Germany, 01067
Essen, Germany, 45239
Gommern, Germany, 39245
Herne, Germany, 44652
Hildesheim, Germany, 31134
Köln, Germany, 50924
München, Germany, 80335
München, Germany, 81541
Osnabrück, Germany, 49074
Sendenhorst, Germany, 48324
Wiesbaden, Germany, 65191
Wuerzburg, Germany, 97080
Hong Kong
Hong Kong, Hong Kong, 852
Tuen Mun, Hong Kong, 852
Iceland
Reykjavik, Iceland, 108
Israel
Ashkelon, Israel, 78306
Haifa, Israel, 34354
Haifa, Israel, 31048
Rishon Lezion, Israel, 70300
Italy
Brescia, Italy, 25123
Genova, Italy, 16132
Milano, Italy, 20157
Padova, Italy, 35128
Pavia, Italy, 27100
Pisa, Italy, 56100
Siena, Italy, 53100
Udine, Italy, 33100
Lithuania
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 92288
Panevezys, Lithuania, 35144
Siauliai, Lithuania, 76231
Vilnius, Lithuania, LT-08661
Mexico
Guadalajara, Mexico, 44340
Guadalajara, Mexico, 44620
Guadalajara, Mexico, 45235
Leon, Mexico, 37000
Mexico City, Mexico, 07760
Mexico City, Mexico, 06700
Mexico City, Mexico, 14050
Tijuana, Mexico, 22320
Netherlands
Nijmegen, Netherlands, 6525 GA
Norway
Levanger, Norway, 7600
Lillehammer, Norway, 2609
Panama
Panama City, Panama, 32400
Peru
Lima, Peru, 11
Lima, Peru, 13
Portugal
Lisboa, Portugal, 1349-019
Puerto Rico
Ponce, Puerto Rico, 00716
Russian Federation
Moscow, Russian Federation, 105203
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 115522
Ryazan, Russian Federation, 390026
St Petersburg, Russian Federation, 191015
St Petersburg, Russian Federation, 190068
Tula, Russian Federation, 300053
Serbia
Belgrade, Serbia, 11000
Niska Banja, Serbia, 18250
Slovenia
Ljubljana, Slovenia, 1000
Maribor, Slovenia, 2000
South Africa
Cape Town, South Africa, 4001
Cape Town, South Africa, 7500
Diepkloof, South Africa, 1862
Durban, South Africa, 4001
Pinelands, South Africa, 7405
Pretoria, South Africa, 0002
Radiokop, South Africa, 2040
Spain
Barakaldo, Spain, 48903
Barcelona, Spain, 08035
Madrid, Spain, 28046
Malaga, Spain, 29010
Pontevedra, Spain, 36001
Santiago de Compostela, Spain, 15706
Sweden
Stockholm, Sweden, 17176
Umea, Sweden, 90185
Switzerland
Lausanne, Switzerland, 1011
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
United Kingdom
Basingstoke, United Kingdom, RG24 9NA
Birmingham, United Kingdom, B29 6JD
Cannock, United Kingdom, WS11 5XY
Derby, United Kingdom, DE1 2QY
Leeds, United Kingdom, LS7 4SA
London, United Kingdom, SE1 9RT
Manchester, United Kingdom, M13 9WL
Manchester, United Kingdom, M41 5SL
Middlesborough, United Kingdom, TS4 3BW
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Oxford, United Kingdom, OX3 7LD
Southampton, United Kingdom, SO16 6YD
Stoke-on-trent, United Kingdom, ST6 7AG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00720798     History of Changes
Other Study ID Numbers: WA18696
Study First Received: July 22, 2008
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014