Back to resultsA Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
tocilizumab [RoActemra/Actemra]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: patients at least 18 years of age with moderate to severe active RA for at least 6 months; inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs; stable DMARD therapy for at least 8 weeks before entering study; patients of reproductive potential must be using reliable methods of contraception. Exclusion Criteria: major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; patients who have previously failed treatment with an anti-tumor necrosis factor agent; women who are pregnant or breast-feeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with ACR 20 response
Secondary Outcome Measures
Percentage of patients with ACR 50 and ACR 70 responses.
Mean changes in parameters of ACR core set
AEs, laboratory parameters, vital signs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00106574
Brief Title
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official Title
A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv every 4 weeks
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
8mg/kg iv every 4 weeks
Primary Outcome Measure Information:
Title
Percentage of patients with ACR 20 response
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of patients with ACR 50 and ACR 70 responses.
Time Frame
Week 24
Title
Mean changes in parameters of ACR core set
Time Frame
Week 24
Title
AEs, laboratory parameters, vital signs.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients at least 18 years of age with moderate to severe active RA for at least 6 months;
inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
stable DMARD therapy for at least 8 weeks before entering study;
patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria:
major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
patients who have previously failed treatment with an anti-tumor necrosis factor agent;
women who are pregnant or breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
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United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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United States
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
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United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
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United States
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San Jose
State/Province
California
ZIP/Postal Code
95126
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United States
City
Upland
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California
ZIP/Postal Code
91786
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United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
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United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
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United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
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United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
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United States
City
Palm Habor
State/Province
Florida
ZIP/Postal Code
34684
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United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
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United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
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United States
City
Chicago
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Illinois
ZIP/Postal Code
60611
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United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
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United States
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Vernon Hills
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Illinois
ZIP/Postal Code
60061
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United States
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Indianapolis
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Indiana
ZIP/Postal Code
46202
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United States
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Bowling Green
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Kentucky
ZIP/Postal Code
42102
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United States
City
Baton Rouge
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Louisiana
ZIP/Postal Code
70808
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United States
City
Shreverport
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Louisiana
ZIP/Postal Code
71103
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United States
City
Frederick
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Maryland
ZIP/Postal Code
21702
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United States
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Boston
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Massachusetts
ZIP/Postal Code
02111
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United States
City
Lansing
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Michigan
ZIP/Postal Code
48910
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United States
City
Duluth
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Minnesota
ZIP/Postal Code
55805
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United States
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
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United States
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
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United States
City
Saint Louis
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Missouri
ZIP/Postal Code
63117
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United States
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Springfield
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Missouri
ZIP/Postal Code
65807
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United States
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Lincoln
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Nebraska
ZIP/Postal Code
68516
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United States
City
Reno
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Nevada
ZIP/Postal Code
89502
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United States
City
Clifton
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New Jersey
ZIP/Postal Code
07012
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United States
City
Haddon Heights
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New Jersey
ZIP/Postal Code
08035
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United States
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New Brunswick
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New Jersey
ZIP/Postal Code
08903
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United States
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Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
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United States
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New York
State/Province
New York
ZIP/Postal Code
10021
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United States
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Plainview
State/Province
New York
ZIP/Postal Code
11803
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United States
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Roslyn
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New York
ZIP/Postal Code
11576
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United States
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Smithtown
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New York
ZIP/Postal Code
11787
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United States
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Syracuse
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New York
ZIP/Postal Code
13210
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United States
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Durham
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North Carolina
ZIP/Postal Code
27704
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United States
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Raleigh
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North Carolina
ZIP/Postal Code
27609
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United States
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Winston Salem
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North Carolina
ZIP/Postal Code
27157
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United States
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Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
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United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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United States
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Dayton
State/Province
Ohio
ZIP/Postal Code
45408
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United States
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
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United States
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Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
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United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
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United States
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Medford
State/Province
Oregon
ZIP/Postal Code
97504
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United States
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Allentown
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Pennsylvania
ZIP/Postal Code
18103
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United States
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Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
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United States
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
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United States
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
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United States
City
Rockledge
State/Province
Pennsylvania
ZIP/Postal Code
19046
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United States
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
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United States
City
Johnston
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Rhode Island
ZIP/Postal Code
02919
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United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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United States
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
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United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
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United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
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United States
City
Mesquite
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Texas
ZIP/Postal Code
75150
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United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22204
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United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
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United States
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
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United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
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United States
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1428DQG
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Argentina
City
Rosario
ZIP/Postal Code
S2000PBJ
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Argentina
City
Parkville
ZIP/Postal Code
3052
Country
Australia
City
Sydney
ZIP/Postal Code
2050
Country
Australia
City
Campinas
ZIP/Postal Code
13060-803
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Brazil
City
Goiania
ZIP/Postal Code
74653-050
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Brazil
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
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Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
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Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
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Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
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Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
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Canada
City
Beijing
ZIP/Postal Code
100032
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Shanghai
ZIP/Postal Code
200127
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Praha
ZIP/Postal Code
128 50
Country
Czech Republic
City
Praha
ZIP/Postal Code
140 59
Country
Czech Republic
City
Helsinki
ZIP/Postal Code
00280
Country
Finland
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
City
Boulogne-billancourt
ZIP/Postal Code
92104
Country
France
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
City
Grenoble
ZIP/Postal Code
38042
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nantes
ZIP/Postal Code
44035
Country
France
City
Paris
ZIP/Postal Code
75181
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Rennes
ZIP/Postal Code
35203
Country
France
City
Saint-etienne
ZIP/Postal Code
4200
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Aachen
ZIP/Postal Code
52064
Country
Germany
City
Essen
ZIP/Postal Code
45239
Country
Germany
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
City
München
ZIP/Postal Code
80335
Country
Germany
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
City
Sendenhorst
ZIP/Postal Code
48324
Country
Germany
City
Stuttgart
ZIP/Postal Code
70469
Country
Germany
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Tuen Mun
ZIP/Postal Code
852
Country
Hong Kong
City
Leon
ZIP/Postal Code
37000
Country
Mexico
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
City
Tijuana
ZIP/Postal Code
22320
Country
Mexico
City
Panama City
ZIP/Postal Code
32400
Country
Panama
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
City
Durban
ZIP/Postal Code
4001
Country
South Africa
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
City
Radiokop
ZIP/Postal Code
2040
Country
South Africa
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
City
Umea
ZIP/Postal Code
90185
Country
Sweden
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
27744141
Citation
Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.
Results Reference
derived
PubMed Identifier
24429164
Citation
Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.
Results Reference
derived
PubMed Identifier
22491018
Citation
Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.
Results Reference
derived
PubMed Identifier
18821691
Citation
Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.
Results Reference
derived
Learn more about this trial
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
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