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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01232569




Registration number
NCT01232569
Ethics application status
Date submitted
1/11/2010
Date registered
2/11/2010
Date last updated
29/07/2015

Titles & IDs
Public title
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Scientific title
A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2010-019912-18
Secondary ID [2] 0 0
NA25220
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 162 mg
Treatment: Drugs - Placebo

Experimental: Tocilizumab 162 mg sc - Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.

Placebo Comparator: Placebo sc - Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.


Treatment: Drugs: Tocilizumab 162 mg
Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.

Treatment: Drugs: Placebo
Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Percentage of Patients With ACR50 and ACR70 Responses at Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [2] 0 0
Time to Onset of ACR20, ACR50, and ACR70 Responses
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [3] 0 0
Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Change From Baseline in C-reactive Protein at Week 24
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Change From Baseline in Erythrocyte Sedimentation Rate at Week 24
Timepoint [5] 0 0
Baseline to Week 24
Secondary outcome [6] 0 0
Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Change From Baseline in the Patient's Pain Visual Analog Score
Timepoint [7] 0 0
Baseline to Week 24
Secondary outcome [8] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
Percentage of Patients With an Improvement of = 0.3 Units From Baseline in the HAQ-DI Score at Week 24
Timepoint [9] 0 0
Baseline to Week 24
Secondary outcome [10] 0 0
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24
Timepoint [10] 0 0
Baseline to Week 24
Secondary outcome [11] 0 0
Percentage of Patients With a DAS28 Score = 3.2 (DAS28 Low Disease Activity) at Week 24
Timepoint [11] 0 0
Baseline to Week 24
Secondary outcome [12] 0 0
Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24
Timepoint [13] 0 0
Baseline to Week 24
Secondary outcome [14] 0 0
Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24
Timepoint [14] 0 0
Baseline to Week 24
Secondary outcome [15] 0 0
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24
Timepoint [15] 0 0
Baseline to Week 24
Secondary outcome [16] 0 0
Change From Baseline in Hemoglobin at Week 24
Timepoint [16] 0 0
Baseline to Week 24

Eligibility
Key inclusion criteria
- Adult patients, = years of age.

- Moderate to severe rheumatoid arthritis of = 6 months duration.

- Receiving treatment on an outpatient basis.

- Swollen joint count (SJC) = 6 (66 joint count) and tender joint count (TJC)= 8 (68
joint count) at screening and study start.

- On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior
to study start.
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 prior to screening or planned
major surgery within 6 months following randomization.

- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's
Syndrome with rheumatoid arthritis is allowed.

- Functional class IV as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in Rheumatoid Arthritis.

- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or
rheumatoid arthritis before the age of 16 years.

- Prior history of or current inflammatory joint disease other than rheumatoid
arthritis.

- History of malignancy, active or recurrent infections, positive to hepatitis B surface
antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or
a history of diverticular disease or other symptomatic GI conditions that might
predispose to perforations.

Other inclusion and exclusion criteria applied to the study.

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 assessing the outcomes
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
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
656
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- Kogarah
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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State/province [3] 0 0
Connecticut
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State/province [4] 0 0
Florida
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State/province [5] 0 0
Georgia
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Idaho
Country [7] 0 0
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Illinois
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United States of America
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Maryland
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Mississippi
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Missouri
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Nebraska
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New York
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North Carolina
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
State/province [20] 0 0
Córdoba
Country [21] 0 0
Argentina
State/province [21] 0 0
San Miguel de Tucuman
Country [22] 0 0
Brazil
State/province [22] 0 0
Curitiba
Country [23] 0 0
Brazil
State/province [23] 0 0
Goiania
Country [24] 0 0
Brazil
State/province [24] 0 0
Juiz de Fora
Country [25] 0 0
Brazil
State/province [25] 0 0
Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Brazil
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Vitoria
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Bulgaria
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Plovdiv
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Sofia
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Varna
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Canada
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Ontario
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Quebec
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Bogota
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Medellin
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Greece
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Athens
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Greece
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Thessaloniki
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Guatemala
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Guatemala City
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Hungary
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Budapest
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Hungary
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Debrecen
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Ramat Gan
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Israel
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Rishon Lezion
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Israel
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Tel Aviv
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Malaysia
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Batu Caves
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Malaysia
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Kota Kinabalu
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Malaysia
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Kuala Lumpur
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Mexico
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Chihuahua
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Culiacan
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Leon
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Merida
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Mexicali
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Mexico
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Mexico
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Morelia
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Obregon
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Queretaro
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New Zealand
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Panama City
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Davao
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Manila
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Bytom
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Elblag
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Krakow
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Torun
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Warszawa
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Russian Federation
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Kemerovo
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Moscow
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Russian Federation
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Novosibirsk
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Petrozavodsk
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Ryazan
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Saint-petersburg
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St Petersburg
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UFA
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Voronezh
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South Africa
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Durban
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South Africa
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Pinelands
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South Africa
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Pretoria
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Spain
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La Coruna
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Spain
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Oviedo
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Spain
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Sevilla
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Switzerland
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Fribourg
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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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Zürich
Country [96] 0 0
Thailand
State/province [96] 0 0
Bangkok

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

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the
reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in
combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with
active, moderate to severe rheumatoid arthritis. In the double-blind part of the study,
patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously
every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study,
patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from
Week 24 to Week 96 using a pre-filled syringe or an auto-injector.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01232569
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