COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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/show/NCT00750880




Registration number
NCT00750880
Ethics application status
Date submitted
10/09/2008
Date registered
11/09/2008
Date last updated
22/07/2015

Titles & IDs
Public title
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Scientific title
International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.
Secondary ID [1] 0 0
2008-000587-17
Secondary ID [2] 0 0
MA21573
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 [RoActemra/Actemra]

Experimental: 1 -


Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg iv (60 minute infusion)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs): Overall Summary - Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
Timepoint [1] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit - DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (=)3.2 and remission was defined as DAS28 less than (<)2.6.
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [2] 0 0
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event - DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 =3.2 and remission was defined as DAS28 <2.6.
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [3] 0 0
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event - The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 =3.2 and remission defined as DAS28 <2.6.
Timepoint [3] 0 0
Baseline,Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit - DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =5.1 or change from baseline >0.6 to =<1.2 with DAS28 =5.1; non-responders: change from baseline =0.6 or change from baseline >0.6 and =1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.
Timepoint [4] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [5] 0 0
DAS28 Scores by Visit - DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [6] 0 0
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit - ACR20, ACR50, ACR70, and ACR90 are defined as =20%, =50%, =70%, or =90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and =20%, =50%, =70%, or =90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.
Timepoint [6] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [7] 0 0
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event - ACR20, ACR50, ACR70, and ACR90 are defined as =20%, =50%, =70%, or =90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and =20%, =50%, =70%, or =90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).
Timepoint [7] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [8] 0 0
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - ACR20, ACR50, ACR70, and ACR90 are defined as =20%, =50%, =70%, or =90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and =20%, =50%, =70%, or =90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.
Timepoint [8] 0 0
Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [9] 0 0
Swollen Joint Count by Visit - Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.
Timepoint [9] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [10] 0 0
Tender Joint Count by Visit - Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.
Timepoint [10] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [11] 0 0
Patient's Global Assessment of Disease Activity by Visit - The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as "maximum disease activity" (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Timepoint [11] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [12] 0 0
Physician's Global Assessment of Disease Activity by Visit - The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Timepoint [12] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [13] 0 0
Patient's Global Assessment of Pain by Visit - The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as "no pain" and the right-hand extreme=100 mm as "unbearable pain". The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Timepoint [13] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [14] 0 0
C-Reactive Protein by Visit - The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Timepoint [14] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [15] 0 0
Erythrocyte Sedimentation Rate by Visit - ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.
Timepoint [15] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [16] 0 0
HAQ-DI Scores by Visit - HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Timepoint [16] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [17] 0 0
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit - The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.
Timepoint [17] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [18] 0 0
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit - The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of =0.22.
Timepoint [18] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [19] 0 0
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit - FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Timepoint [19] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24

Eligibility
Key inclusion criteria
- male and non-pregnant or nursing female patients >=18 years of age;

- body weight <=150kg;

- moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;

- on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start
of treatment;

- inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF
therapy;

- if receiving oral corticosteroids, the dose must have been stable for at least 25 of
28 days prior to start of treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
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 enrollment;

- rheumatic autoimmune disease other than RA;

- prior history of, or current inflammatory joint disease other than RA;

- functional class IV as defined by the ACR Classification of Functional Status in RA.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Parramatta Park
Recruitment hospital [5] 0 0
- Adelaide
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4870 - Parramatta Park
Recruitment postcode(s) [5] 0 0
5041 - Adelaide
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz-Eggenberg
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Austria
State/province [4] 0 0
Linz
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
Stockerau
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Belgium
State/province [8] 0 0
Aalst
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Belgium
State/province [12] 0 0
Hasselt
Country [13] 0 0
Belgium
State/province [13] 0 0
Heusy
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Belgium
State/province [16] 0 0
Merksem
Country [17] 0 0
Belgium
State/province [17] 0 0
Montignies S/ Sambre
Country [18] 0 0
Belgium
State/province [18] 0 0
Westmalle
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
New Brunswick
Country [22] 0 0
Canada
State/province [22] 0 0
Newfoundland and Labrador
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Canada
State/province [25] 0 0
Saskatchewan
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Bruntal
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Ostrava
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Praha
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Sokolov
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Uherske Hradiste
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Zlin
Country [32] 0 0
Denmark
State/province [32] 0 0
Esbjerg
Country [33] 0 0
Denmark
State/province [33] 0 0
Hjørring
Country [34] 0 0
Denmark
State/province [34] 0 0
København
Country [35] 0 0
Denmark
State/province [35] 0 0
Silkeborg
Country [36] 0 0
Denmark
State/province [36] 0 0
Århus
Country [37] 0 0
Finland
State/province [37] 0 0
Helsinki
Country [38] 0 0
Finland
State/province [38] 0 0
Jyvaeskylae
Country [39] 0 0
Finland
State/province [39] 0 0
Turku
Country [40] 0 0
France
State/province [40] 0 0
Argenteuil
Country [41] 0 0
France
State/province [41] 0 0
Aulnay Sous Bois
Country [42] 0 0
France
State/province [42] 0 0
Belfort
Country [43] 0 0
France
State/province [43] 0 0
Bobigny
Country [44] 0 0
France
State/province [44] 0 0
Bourg En Bresse
Country [45] 0 0
France
State/province [45] 0 0
Caen
Country [46] 0 0
France
State/province [46] 0 0
Cahors
Country [47] 0 0
France
State/province [47] 0 0
Colmar
Country [48] 0 0
France
State/province [48] 0 0
Corbeil-essonnes
Country [49] 0 0
France
State/province [49] 0 0
Dijon
Country [50] 0 0
France
State/province [50] 0 0
La Rochelle
Country [51] 0 0
France
State/province [51] 0 0
Lievin
Country [52] 0 0
France
State/province [52] 0 0
Lomme
Country [53] 0 0
France
State/province [53] 0 0
Lyon
Country [54] 0 0
France
State/province [54] 0 0
Marseille
Country [55] 0 0
France
State/province [55] 0 0
Montivilliers
Country [56] 0 0
France
State/province [56] 0 0
Montpellier
Country [57] 0 0
France
State/province [57] 0 0
Mulhouse
Country [58] 0 0
France
State/province [58] 0 0
Paris
Country [59] 0 0
France
State/province [59] 0 0
Pau
Country [60] 0 0
France
State/province [60] 0 0
Poitiers
Country [61] 0 0
France
State/province [61] 0 0
Reims
Country [62] 0 0
France
State/province [62] 0 0
Roubaix
Country [63] 0 0
France
State/province [63] 0 0
St Brieuc
Country [64] 0 0
France
State/province [64] 0 0
Strasbourg
Country [65] 0 0
France
State/province [65] 0 0
Toulouse
Country [66] 0 0
France
State/province [66] 0 0
Valence
Country [67] 0 0
France
State/province [67] 0 0
Valenciennes
Country [68] 0 0
Germany
State/province [68] 0 0
Berlin
Country [69] 0 0
Germany
State/province [69] 0 0
Bielefeld
Country [70] 0 0
Germany
State/province [70] 0 0
Freiburg
Country [71] 0 0
Germany
State/province [71] 0 0
Greifswald
Country [72] 0 0
Germany
State/province [72] 0 0
Hamburg
Country [73] 0 0
Germany
State/province [73] 0 0
Jena
Country [74] 0 0
Germany
State/province [74] 0 0
Kiel
Country [75] 0 0
Germany
State/province [75] 0 0
Rostock
Country [76] 0 0
Germany
State/province [76] 0 0
Saarbruecken
Country [77] 0 0
Germany
State/province [77] 0 0
Wuerzburg
Country [78] 0 0
Germany
State/province [78] 0 0
Wuppertal
Country [79] 0 0
Greece
State/province [79] 0 0
Athens
Country [80] 0 0
Greece
State/province [80] 0 0
Heraklion
Country [81] 0 0
Greece
State/province [81] 0 0
Ioannina
Country [82] 0 0
Greece
State/province [82] 0 0
Patras
Country [83] 0 0
Greece
State/province [83] 0 0
Thessaloniki
Country [84] 0 0
Hungary
State/province [84] 0 0
Budapest
Country [85] 0 0
Hungary
State/province [85] 0 0
Eger
Country [86] 0 0
Hungary
State/province [86] 0 0
Gyula
Country [87] 0 0
Hungary
State/province [87] 0 0
Szeged
Country [88] 0 0
Hungary
State/province [88] 0 0
Veszprem
Country [89] 0 0
India
State/province [89] 0 0
Bangalore
Country [90] 0 0
India
State/province [90] 0 0
Chennai
Country [91] 0 0
India
State/province [91] 0 0
Hyderabad
Country [92] 0 0
India
State/province [92] 0 0
Jaipur
Country [93] 0 0
India
State/province [93] 0 0
Kolkata
Country [94] 0 0
India
State/province [94] 0 0
Ludhiana
Country [95] 0 0
India
State/province [95] 0 0
Mumbai
Country [96] 0 0
India
State/province [96] 0 0
New Delhi
Country [97] 0 0
India
State/province [97] 0 0
Pune
Country [98] 0 0
Ireland
State/province [98] 0 0
Co Leitrim
Country [99] 0 0
Ireland
State/province [99] 0 0
Cork
Country [100] 0 0
Ireland
State/province [100] 0 0
Dublin
Country [101] 0 0
Ireland
State/province [101] 0 0
Galway
Country [102] 0 0
Ireland
State/province [102] 0 0
Limerick
Country [103] 0 0
Ireland
State/province [103] 0 0
Waterford
Country [104] 0 0
Italy
State/province [104] 0 0
Arenzano
Country [105] 0 0
Italy
State/province [105] 0 0
Legnano
Country [106] 0 0
Italy
State/province [106] 0 0
Milano
Country [107] 0 0
Italy
State/province [107] 0 0
Modena
Country [108] 0 0
Italy
State/province [108] 0 0
Monserrato
Country [109] 0 0
Italy
State/province [109] 0 0
Novara
Country [110] 0 0
Italy
State/province [110] 0 0
Palermo
Country [111] 0 0
Italy
State/province [111] 0 0
Pescara
Country [112] 0 0
Italy
State/province [112] 0 0
Potenza
Country [113] 0 0
Italy
State/province [113] 0 0
Roma
Country [114] 0 0
Italy
State/province [114] 0 0
Siena
Country [115] 0 0
Italy
State/province [115] 0 0
Varese
Country [116] 0 0
Luxembourg
State/province [116] 0 0
Luxembourg
Country [117] 0 0
Netherlands
State/province [117] 0 0
'S Hertogenbosch
Country [118] 0 0
Netherlands
State/province [118] 0 0
Alkmaar
Country [119] 0 0
Netherlands
State/province [119] 0 0
Amsterdam
Country [120] 0 0
Netherlands
State/province [120] 0 0
Apeldoorn
Country [121] 0 0
Netherlands
State/province [121] 0 0
Arnhem
Country [122] 0 0
Netherlands
State/province [122] 0 0
Bergen Op Zoom
Country [123] 0 0
Netherlands
State/province [123] 0 0
Den Haag
Country [124] 0 0
Netherlands
State/province [124] 0 0
Den Helder
Country [125] 0 0
Netherlands
State/province [125] 0 0
Enschede
Country [126] 0 0
Netherlands
State/province [126] 0 0
Gorinchem
Country [127] 0 0
Netherlands
State/province [127] 0 0
Gouda
Country [128] 0 0
Netherlands
State/province [128] 0 0
Heerlen
Country [129] 0 0
Netherlands
State/province [129] 0 0
Hilversum
Country [130] 0 0
Netherlands
State/province [130] 0 0
Leeuwarden
Country [131] 0 0
Netherlands
State/province [131] 0 0
Leidschendam
Country [132] 0 0
Netherlands
State/province [132] 0 0
Nieuwegein
Country [133] 0 0
Netherlands
State/province [133] 0 0
Nijmegen
Country [134] 0 0
Netherlands
State/province [134] 0 0
Roosendaal
Country [135] 0 0
Netherlands
State/province [135] 0 0
Rotterdam
Country [136] 0 0
Netherlands
State/province [136] 0 0
Schiedam
Country [137] 0 0
Netherlands
State/province [137] 0 0
Spijkenisse
Country [138] 0 0
Netherlands
State/province [138] 0 0
Vlissingen
Country [139] 0 0
Poland
State/province [139] 0 0
Krakow
Country [140] 0 0
Poland
State/province [140] 0 0
Poznan
Country [141] 0 0
Poland
State/province [141] 0 0
Wroclaw
Country [142] 0 0
Portugal
State/province [142] 0 0
Almada
Country [143] 0 0
Portugal
State/province [143] 0 0
Coimbra
Country [144] 0 0
Portugal
State/province [144] 0 0
Lisboa
Country [145] 0 0
Portugal
State/province [145] 0 0
Porto
Country [146] 0 0
Romania
State/province [146] 0 0
Bucharest
Country [147] 0 0
Romania
State/province [147] 0 0
Cluj-napoca
Country [148] 0 0
Saudi Arabia
State/province [148] 0 0
Jeddah
Country [149] 0 0
Spain
State/province [149] 0 0
Alicante
Country [150] 0 0
Spain
State/province [150] 0 0
Avila
Country [151] 0 0
Spain
State/province [151] 0 0
Barcelona
Country [152] 0 0
Spain
State/province [152] 0 0
Cadiz
Country [153] 0 0
Spain
State/province [153] 0 0
La Coruña
Country [154] 0 0
Spain
State/province [154] 0 0
Las Palmas
Country [155] 0 0
Spain
State/province [155] 0 0
Leon
Country [156] 0 0
Spain
State/province [156] 0 0
Tenerife
Country [157] 0 0
Spain
State/province [157] 0 0
Almeria
Country [158] 0 0
Spain
State/province [158] 0 0
Caceres
Country [159] 0 0
Spain
State/province [159] 0 0
Cordoba
Country [160] 0 0
Spain
State/province [160] 0 0
Granada
Country [161] 0 0
Spain
State/province [161] 0 0
Huesca
Country [162] 0 0
Spain
State/province [162] 0 0
Lugo
Country [163] 0 0
Spain
State/province [163] 0 0
Madrid
Country [164] 0 0
Spain
State/province [164] 0 0
Malaga
Country [165] 0 0
Spain
State/province [165] 0 0
Murcia
Country [166] 0 0
Spain
State/province [166] 0 0
Orense
Country [167] 0 0
Spain
State/province [167] 0 0
Salamanca
Country [168] 0 0
Spain
State/province [168] 0 0
Sevilla
Country [169] 0 0
Spain
State/province [169] 0 0
Valencia
Country [170] 0 0
Spain
State/province [170] 0 0
Zaragoza
Country [171] 0 0
Sweden
State/province [171] 0 0
Falun
Country [172] 0 0
Sweden
State/province [172] 0 0
Huddinge
Country [173] 0 0
Sweden
State/province [173] 0 0
Karlstad
Country [174] 0 0
Sweden
State/province [174] 0 0
Linkoeping
Country [175] 0 0
Sweden
State/province [175] 0 0
Malmo
Country [176] 0 0
Sweden
State/province [176] 0 0
Skoevde
Country [177] 0 0
Sweden
State/province [177] 0 0
Stockholm
Country [178] 0 0
Sweden
State/province [178] 0 0
Uppsala
Country [179] 0 0
Sweden
State/province [179] 0 0
Västerås
Country [180] 0 0
Switzerland
State/province [180] 0 0
Aarau
Country [181] 0 0
Switzerland
State/province [181] 0 0
Basel
Country [182] 0 0
Switzerland
State/province [182] 0 0
Fribourg
Country [183] 0 0
Switzerland
State/province [183] 0 0
Genève
Country [184] 0 0
Switzerland
State/province [184] 0 0
Luzern
Country [185] 0 0
Switzerland
State/province [185] 0 0
St. Gallen
Country [186] 0 0
Switzerland
State/province [186] 0 0
Zürich
Country [187] 0 0
Turkey
State/province [187] 0 0
Ankara
Country [188] 0 0
Turkey
State/province [188] 0 0
Istanbul
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Barnsley
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Basingstoke
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Bournemouth
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Brighton
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Burton on Trent
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Bury St Edmonds
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Cambridge
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Cardiff
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Chelmsford
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Dudley
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Dundee
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Eastbourne
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Gillingham
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Harrogate
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Huddersfield
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Ipswich
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Liverpool
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Llantrisant
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Londonderry
Country [208] 0 0
United Kingdom
State/province [208] 0 0
London
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Maidstone
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Middlesborough
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Newcastle upon Tyne
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Nottingham
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Reading
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Salford
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Sheffield
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Southport
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Swindon
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Torquay
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Westcliffe-on-sea
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Wirral
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Worthing

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, single arm study will investigate the safety, tolerability and efficacy of
tocilizumab monotherapy, or combination therapy with non-biologic disease modifying
antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive
tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The
anticipated time on study treatment is 3-12 months, and the target sample size is >500
individuals.
Trial website
https://clinicaltrials.gov/show/NCT00750880
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

Summary results
Other publications