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/NCT00106522
Registration number
NCT00106522
Ethics application status
Date submitted
25/03/2005
Date registered
28/03/2005
Date last updated
2/11/2016
Titles & IDs
Public title
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
Query!
Scientific title
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Query!
Secondary ID [1]
0
0
WA18062
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 - Placebo
Treatment: Drugs - tocilizumab [RoActemra/Actemra]
Treatment: Drugs - tocilizumab [RoActemra/Actemra]
Experimental: 1 -
Experimental: 2 -
Placebo comparator: 3 -
Treatment: Drugs: Methotrexate
10-25mg weekly
Treatment: Drugs: Placebo
iv every 4 weeks
Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Treatment: Drugs: tocilizumab [RoActemra/Actemra]
4mg/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!
Primary outcome [2]
0
0
AEs, laboratory parameters, vital signs, ECGs.
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Throughout study
Query!
Secondary outcome [1]
0
0
Percentage of patients with ACR 50 and ACR 70 responses
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [2]
0
0
Mean changes in parameters of ACR core set
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Week 24
Query!
Eligibility
Key inclusion criteria
* adult 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 MTX;
* inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
* on stable MTX for at least 8 weeks before entering study;
* 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 screening, or planned major surgery within 6 months after entering study;
* 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
1/05/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2007
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
499
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Malvern
Query!
Recruitment hospital [2]
0
0
- Shenton Park
Query!
Recruitment hospital [3]
0
0
- Sydney
Query!
Recruitment hospital [4]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [2]
0
0
6008 - Shenton Park
Query!
Recruitment postcode(s) [3]
0
0
2050 - Sydney
Query!
Recruitment postcode(s) [4]
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
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maine
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Mississippi
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Missouri
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Montana
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nevada
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Jersey
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Dakota
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Ohio
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oklahoma
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Oregon
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Pennsylvania
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
South Carolina
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Tennessee
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Texas
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Utah
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Virginia
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Washington
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Wisconsin
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Aalst
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Hasselt
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Merksem
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Alberta
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Manitoba
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Amiens
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Bordeaux
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Le Kremlin Bicetre
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Lille
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Lyon
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Nice
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Paris
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Strasbourg
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Toulouse
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Berlin
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Dresden
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Gommern
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Herne
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Köln
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
München
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Wiesbaden
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Wuerzburg
Query!
Country [61]
0
0
Iceland
Query!
State/province [61]
0
0
Reykjavik
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Brescia
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Milano
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Padova
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Pavia
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Pisa
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Udine
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Guadalajara
Query!
Country [69]
0
0
Netherlands
Query!
State/province [69]
0
0
Enschede
Query!
Country [70]
0
0
Netherlands
Query!
State/province [70]
0
0
Nijmegen
Query!
Country [71]
0
0
Puerto Rico
Query!
State/province [71]
0
0
Ponce
Query!
Country [72]
0
0
Sweden
Query!
State/province [72]
0
0
Jonkoping
Query!
Country [73]
0
0
Sweden
Query!
State/province [73]
0
0
Karlstad
Query!
Country [74]
0
0
Sweden
Query!
State/province [74]
0
0
Malmo
Query!
Country [75]
0
0
Sweden
Query!
State/province [75]
0
0
Stockholm
Query!
Country [76]
0
0
Switzerland
Query!
State/province [76]
0
0
Lausanne
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Basingstoke
Query!
Country [78]
0
0
United Kingdom
Query!
State/province [78]
0
0
Bath
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
Birmingham
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Cannock
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Derby
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
Lancaster
Query!
Country [83]
0
0
United Kingdom
Query!
State/province [83]
0
0
Leeds
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Liverpool
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
London
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Manchester
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Middlesborough
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Newcastle Upon Tyne
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Norwich
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Oxford
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Salford
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Southampton
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Stoke-on-trent
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 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. 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/NCT00106522
Query!
Trial related presentations / publications
Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24. 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. Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. doi: 10.1093/rheumatology/kes131. Epub 2012 Jun 28. Karsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6. Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14. Erratum In: Ann Rheum Dis. 2009 Feb;68(2):296.
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/NCT00106522
Download to PDF