Back to resultsA Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Methotrexate
tocilizumab [RoActemra/Actemra]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: adult patients at least 18 years of age with active RA for at least 3 months; 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 major surgery within 6 months after entering study; treatment with methotrexate (MTX) within 6 months of entering study; patients who have stopped previous MTX treatment due to toxicity or lack of response; women who are pregnant or breast-feeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active 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 20 response
Percentage of patients with ACR 50 and ACR 70 responses
Mean change in parameters of ACR core set
AEs, laboratory parameters, vital signs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00109408
Brief Title
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
Official Title
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 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 assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. 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
673 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
7.5-20mg po weekly
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 20 response
Time Frame
Week 8
Title
Percentage of patients with ACR 50 and ACR 70 responses
Time Frame
Week 24
Title
Mean change 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:
adult patients at least 18 years of age with active RA for at least 3 months;
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 major surgery within 6 months after entering study;
treatment with methotrexate (MTX) within 6 months of entering study;
patients who have stopped previous MTX treatment due to toxicity or lack of response;
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
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Palm Habor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50322
Country
United States
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42102
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
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United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
City
St Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38802
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
City
Hickory
State/Province
South Carolina
ZIP/Postal Code
28602
Country
United States
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1428DQG
Country
Argentina
City
Florencio Varela
ZIP/Postal Code
B1878DVB
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000PBJ
Country
Argentina
City
Adelaide
ZIP/Postal Code
5041
Country
Australia
City
Hobart
ZIP/Postal Code
7000
Country
Australia
City
Shenton Park
ZIP/Postal Code
6008
Country
Australia
City
Sydney
ZIP/Postal Code
2050
Country
Australia
City
Woodville
ZIP/Postal Code
5011
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
City
Guangzhou
ZIP/Postal Code
510630
Country
China
City
Hefei Anhui
ZIP/Postal Code
230022
Country
China
City
Jinan
ZIP/Postal Code
250012
Country
China
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
City
København
ZIP/Postal Code
2400
Country
Denmark
City
Brest
ZIP/Postal Code
29609
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
31048
Country
Israel
City
Haifa
ZIP/Postal Code
34354
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Rishon Lezion
ZIP/Postal Code
70300
Country
Israel
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20157
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Panevezys
ZIP/Postal Code
35144
Country
Lithuania
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
City
Guadalajara
ZIP/Postal Code
45235
Country
Mexico
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
City
Levanger
ZIP/Postal Code
7600
Country
Norway
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
City
Lima
ZIP/Postal Code
11
Country
Peru
City
Lima
ZIP/Postal Code
13
Country
Peru
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
City
Lisboa
ZIP/Postal Code
1050-34
Country
Portugal
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Niska Banja
ZIP/Postal Code
18250
Country
Serbia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
City
Cape Town
ZIP/Postal Code
4001
Country
South Africa
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Diepkloof
ZIP/Postal Code
1862
Country
South Africa
City
Pinelands
ZIP/Postal Code
7405
Country
South Africa
City
Radiokop
ZIP/Postal Code
2040
Country
South Africa
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33413588
Citation
Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.
Results Reference
derived
PubMed Identifier
28955499
Citation
Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.
Results Reference
derived
PubMed Identifier
27909081
Citation
Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.
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
19297346
Citation
Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.
Results Reference
derived
Learn more about this trial
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
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