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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01119859




Registration number
NCT01119859
Ethics application status
Date submitted
1/04/2010
Date registered
10/05/2010
Date last updated
11/02/2013

Titles & IDs
Public title
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
Scientific title
A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
2009-015845-21
Secondary ID [2] 0 0
WA19924
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 - Tocilizumab

Experimental: Tocilizumab 8 mg/kg - Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.

Active comparator: Adalimumab 40 mg - Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.


Treatment: Drugs: Tocilizumab
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] = 3.2) at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
Timepoint [5] 0 0
Baseline to Week 24

Eligibility
Key inclusion criteria
* Adult patients, = 18 years of age.
* Rheumatoid arthritis of > 6 months duration.
* Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
* All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
* Weight = 150 kg.
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 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
* History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
* Treatment with a biologic agent at any time prior to baseline.
* Intra-articular or parenteral corticosteroids = 4 weeks prior to baseline.
* Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.

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 4
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
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
326
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Maroochydore
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Belgium
State/province [22] 0 0
Bruxelles
Country [23] 0 0
Belgium
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Liege
Country [24] 0 0
Brazil
State/province [24] 0 0
Curitiba
Country [25] 0 0
Brazil
State/province [25] 0 0
Goiania
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Brazil
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Sao Paulo
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Czech Republic
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Prague
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Finland
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Helsinki
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Finland
State/province [29] 0 0
Jyväskylä
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-baden
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
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Germany
State/province [33] 0 0
Heidelberg
Country [34] 0 0
Germany
State/province [34] 0 0
Herne
Country [35] 0 0
Germany
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Hildesheim
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Germany
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Köln
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Germany
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Osnabrück
Country [38] 0 0
Germany
State/province [38] 0 0
Ratingen
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Germany
State/province [39] 0 0
Würzburg
Country [40] 0 0
Greece
State/province [40] 0 0
Athens
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Greece
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Heraklion
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Greece
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Thessaloniki
Country [43] 0 0
Mexico
State/province [43] 0 0
Mexicali
Country [44] 0 0
Mexico
State/province [44] 0 0
Mexico, Df
Country [45] 0 0
Mexico
State/province [45] 0 0
Obregon
Country [46] 0 0
Portugal
State/province [46] 0 0
Almada
Country [47] 0 0
Portugal
State/province [47] 0 0
Lisboa
Country [48] 0 0
Portugal
State/province [48] 0 0
Porto
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Santiago de Compostela
Country [53] 0 0
Spain
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Sevilla
Country [54] 0 0
Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Aarau
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Switzerland
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Genève
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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Turkey
State/province [61] 0 0
Ankara
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Turkey
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Antalya
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Turkey
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Istanbul
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United Kingdom
State/province [64] 0 0
Cannock
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Leeds
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United Kingdom
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London
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Newcastle Upon Tyne
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Poole

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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 are available at https://clinicaltrials.gov/study/NCT01119859