Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00106574




Registration number
NCT00106574
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 + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Scientific 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
Secondary ID [1] 0 0
WA18063
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - tocilizumab [RoActemra/Actemra]

Experimental: 1 -

Placebo Comparator: 2 -


Treatment: Drugs: Placebo
iv every 4 weeks

Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with ACR 20 response
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of patients with ACR 50 and ACR 70 responses.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Mean changes in parameters of ACR core set
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
AEs, laboratory parameters, vital signs.
Timepoint [3] 0 0
Throughout study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
1220
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Parkville
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
Rhode Island
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Vermont
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Rosario
Country [36] 0 0
Brazil
State/province [36] 0 0
Campinas
Country [37] 0 0
Brazil
State/province [37] 0 0
Goiania
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio de Janeiro
Country [39] 0 0
Canada
State/province [39] 0 0
Manitoba
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Canada
State/province [42] 0 0
Saskatchewan
Country [43] 0 0
China
State/province [43] 0 0
Beijing
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
Costa Rica
State/province [45] 0 0
San Jose
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Praha
Country [48] 0 0
Finland
State/province [48] 0 0
Helsinki
Country [49] 0 0
Finland
State/province [49] 0 0
Jyväskylä
Country [50] 0 0
France
State/province [50] 0 0
Boulogne-billancourt
Country [51] 0 0
France
State/province [51] 0 0
Clermont-ferrand
Country [52] 0 0
France
State/province [52] 0 0
Grenoble
Country [53] 0 0
France
State/province [53] 0 0
Limoges
Country [54] 0 0
France
State/province [54] 0 0
Marseille
Country [55] 0 0
France
State/province [55] 0 0
Montpellier
Country [56] 0 0
France
State/province [56] 0 0
Nantes
Country [57] 0 0
France
State/province [57] 0 0
Paris
Country [58] 0 0
France
State/province [58] 0 0
Pierre Benite
Country [59] 0 0
France
State/province [59] 0 0
Rennes
Country [60] 0 0
France
State/province [60] 0 0
Saint-etienne
Country [61] 0 0
France
State/province [61] 0 0
Tours
Country [62] 0 0
Germany
State/province [62] 0 0
Aachen
Country [63] 0 0
Germany
State/province [63] 0 0
Essen
Country [64] 0 0
Germany
State/province [64] 0 0
Hildesheim
Country [65] 0 0
Germany
State/province [65] 0 0
München
Country [66] 0 0
Germany
State/province [66] 0 0
Osnabrück
Country [67] 0 0
Germany
State/province [67] 0 0
Sendenhorst
Country [68] 0 0
Germany
State/province [68] 0 0
Stuttgart
Country [69] 0 0
Hong Kong
State/province [69] 0 0
Hong Kong
Country [70] 0 0
Hong Kong
State/province [70] 0 0
Tuen Mun
Country [71] 0 0
Mexico
State/province [71] 0 0
Leon
Country [72] 0 0
Mexico
State/province [72] 0 0
Mexico City
Country [73] 0 0
Mexico
State/province [73] 0 0
Tijuana
Country [74] 0 0
Panama
State/province [74] 0 0
Panama City
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moscow
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Ryazan
Country [77] 0 0
Russian Federation
State/province [77] 0 0
St Petersburg
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Tula
Country [79] 0 0
South Africa
State/province [79] 0 0
Durban
Country [80] 0 0
South Africa
State/province [80] 0 0
Pretoria
Country [81] 0 0
South Africa
State/province [81] 0 0
Radiokop
Country [82] 0 0
Spain
State/province [82] 0 0
Barakaldo
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Malaga
Country [85] 0 0
Spain
State/province [85] 0 0
Pontevedra
Country [86] 0 0
Spain
State/province [86] 0 0
Santiago de Compostela
Country [87] 0 0
Sweden
State/province [87] 0 0
Stockholm
Country [88] 0 0
Sweden
State/province [88] 0 0
Umea
Country [89] 0 0
Thailand
State/province [89] 0 0
Bangkok
Country [90] 0 0
Thailand
State/province [90] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00106574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries