Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00109408
Registration number
NCT00109408
Ethics application status
Date submitted
27/04/2005
Date registered
28/04/2005
Date last updated
2/11/2016
Titles & IDs
Public title
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
WA17824
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Methotrexate
Treatment: Drugs - tocilizumab [RoActemra/Actemra]
Experimental: 1 -
Active comparator: 2 -
Treatment: Drugs: Methotrexate
7.5-20mg po weekly
Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of patients with ACR 20 response
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Percentage of patients with ACR 20 response
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 8
Query!
Secondary outcome [2]
0
0
Percentage of patients with ACR 50 and ACR 70 responses
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Week 24
Query!
Secondary outcome [3]
0
0
Mean change in parameters of ACR core set
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Week 24
Query!
Secondary outcome [4]
0
0
AEs, laboratory parameters, vital signs.
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Throughout study
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2007
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
673
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Hobart
Query!
Recruitment hospital [3]
0
0
- Shenton Park
Query!
Recruitment hospital [4]
0
0
- Sydney
Query!
Recruitment hospital [5]
0
0
- Woodville
Query!
Recruitment hospital [6]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5041 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [3]
0
0
6008 - Shenton Park
Query!
Recruitment postcode(s) [4]
0
0
2050 - Sydney
Query!
Recruitment postcode(s) [5]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [6]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Mississippi
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Hampshire
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Virginia
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Washington
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Florencio Varela
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Rosario
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Manitoba
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Newfoundland and Labrador
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Guangzhou
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Hefei Anhui
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Jinan
Query!
Country [40]
0
0
Denmark
Query!
State/province [40]
0
0
Hillerod
Query!
Country [41]
0
0
Denmark
Query!
State/province [41]
0
0
Hvidovre
Query!
Country [42]
0
0
Denmark
Query!
State/province [42]
0
0
København
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Brest
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Lyon
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Paris
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Rouen
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Ashkelon
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Beer Sheva
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Haifa
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Kfar Saba
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Ramat Gan
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Rishon Lezion
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Genova
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Milano
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Pavia
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Reggio Emilia
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Siena
Query!
Country [58]
0
0
Lithuania
Query!
State/province [58]
0
0
Kaunas
Query!
Country [59]
0
0
Lithuania
Query!
State/province [59]
0
0
Klaipeda
Query!
Country [60]
0
0
Lithuania
Query!
State/province [60]
0
0
Panevezys
Query!
Country [61]
0
0
Lithuania
Query!
State/province [61]
0
0
Siauliai
Query!
Country [62]
0
0
Lithuania
Query!
State/province [62]
0
0
Vilnius
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Guadalajara
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Mexico City
Query!
Country [65]
0
0
Norway
Query!
State/province [65]
0
0
Levanger
Query!
Country [66]
0
0
Norway
Query!
State/province [66]
0
0
Lillehammer
Query!
Country [67]
0
0
Peru
Query!
State/province [67]
0
0
Lima
Query!
Country [68]
0
0
Portugal
Query!
State/province [68]
0
0
Almada
Query!
Country [69]
0
0
Portugal
Query!
State/province [69]
0
0
Lisboa
Query!
Country [70]
0
0
Serbia
Query!
State/province [70]
0
0
Belgrade
Query!
Country [71]
0
0
Serbia
Query!
State/province [71]
0
0
Niska Banja
Query!
Country [72]
0
0
Slovenia
Query!
State/province [72]
0
0
Ljubljana
Query!
Country [73]
0
0
Slovenia
Query!
State/province [73]
0
0
Maribor
Query!
Country [74]
0
0
South Africa
Query!
State/province [74]
0
0
Cape Town
Query!
Country [75]
0
0
South Africa
Query!
State/province [75]
0
0
Diepkloof
Query!
Country [76]
0
0
South Africa
Query!
State/province [76]
0
0
Pinelands
Query!
Country [77]
0
0
South Africa
Query!
State/province [77]
0
0
Radiokop
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Alcorcon
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Barcelona
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Córdoba
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Guadalajara
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
La Laguna
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Lugo
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Salamanca
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Santiago de Compostela
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00109408
Query!
Trial related presentations / publications
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. 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. 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. 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00109408
Download to PDF