Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/study/NCT00720798




Registration number
NCT00720798
Ethics application status
Date submitted
22/07/2008
Date registered
23/07/2008
Date last updated
30/09/2014

Titles & IDs
Public title
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Scientific title
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
Secondary ID [1] 0 0
WA18696
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
Treatment: Drugs - Disease-modifying anti-rheumatic drugs
Treatment: Drugs - Non-steroidal anti-inflammatory drugs
Treatment: Drugs - Oral corticosteroids

Experimental: Tocilizumab - Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.


Treatment: Drugs: Tocilizumab
For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.

Treatment: Drugs: Disease-modifying anti-rheumatic drugs
Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.

Treatment: Drugs: Non-steroidal anti-inflammatory drugs
Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.

Treatment: Drugs: Oral corticosteroids
Oral corticosteroids (= 10 mg/day) were permitted during the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With = 1 Adverse Event
Timepoint [1] 0 0
Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcome [1] 0 0
Percentage of Participants Who Withdrew From Treatment
Timepoint [1] 0 0
Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcome [2] 0 0
Percentage of Participants With Concomitant Oral Corticosteroid Therapy
Timepoint [2] 0 0
Baseline to the end of the study (up to 7 years, 7 months)
Secondary outcome [3] 0 0
Percentage of Participants Who Changed From Monotherapy to Combination Therapy
Timepoint [3] 0 0
Baseline to Week 296
Secondary outcome [4] 0 0
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264
Timepoint [4] 0 0
Baseline to Week 264
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
Timepoint [5] 0 0
Baseline to Week 264
Secondary outcome [6] 0 0
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264
Timepoint [6] 0 0
Baseline to Week 264
Secondary outcome [7] 0 0
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Timepoint [7] 0 0
Baseline to Week 264
Secondary outcome [8] 0 0
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Timepoint [8] 0 0
Baseline to Week 264
Secondary outcome [9] 0 0
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Timepoint [9] 0 0
Baseline to Week 264
Secondary outcome [10] 0 0
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Timepoint [10] 0 0
Baseline to Week 264
Secondary outcome [11] 0 0
Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264
Timepoint [11] 0 0
Baseline to Week 264
Secondary outcome [12] 0 0
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
Timepoint [12] 0 0
Baseline to Week 264
Secondary outcome [13] 0 0
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264
Timepoint [13] 0 0
Baseline to Week 264
Secondary outcome [14] 0 0
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264
Timepoint [14] 0 0
Baseline to Week 264
Secondary outcome [15] 0 0
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264
Timepoint [15] 0 0
Baseline to Week 264

Eligibility
Key inclusion criteria
* Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Treatment with any investigational agent since the last administration of study drug in the core studies.
* Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
* Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
* Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
* Previous treatment with any cell-depleting therapies, including investigational agents.
* Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
2067
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Hobart
Recruitment hospital [2] 0 0
- Malvern
Recruitment hospital [3] 0 0
- Shenton Park
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
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
Delaware
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
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
Montana
Country [23] 0 0
United States of America
State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
Nevada
Country [25] 0 0
United States of America
State/province [25] 0 0
New Hampshire
Country [26] 0 0
United States of America
State/province [26] 0 0
New Jersey
Country [27] 0 0
United States of America
State/province [27] 0 0
New Mexico
Country [28] 0 0
United States of America
State/province [28] 0 0
New York
Country [29] 0 0
United States of America
State/province [29] 0 0
North Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
North Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Ohio
Country [32] 0 0
United States of America
State/province [32] 0 0
Oklahoma
Country [33] 0 0
United States of America
State/province [33] 0 0
Oregon
Country [34] 0 0
United States of America
State/province [34] 0 0
Pennsylvania
Country [35] 0 0
United States of America
State/province [35] 0 0
Rhode Island
Country [36] 0 0
United States of America
State/province [36] 0 0
South Carolina
Country [37] 0 0
United States of America
State/province [37] 0 0
Tennessee
Country [38] 0 0
United States of America
State/province [38] 0 0
Texas
Country [39] 0 0
United States of America
State/province [39] 0 0
Vermont
Country [40] 0 0
United States of America
State/province [40] 0 0
Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Washington
Country [42] 0 0
United States of America
State/province [42] 0 0
Wisconsin
Country [43] 0 0
Argentina
State/province [43] 0 0
Buenos Aires
Country [44] 0 0
Argentina
State/province [44] 0 0
Florencio Varela
Country [45] 0 0
Argentina
State/province [45] 0 0
Rosario
Country [46] 0 0
Belgium
State/province [46] 0 0
Hasselt
Country [47] 0 0
Belgium
State/province [47] 0 0
Merksem
Country [48] 0 0
Brazil
State/province [48] 0 0
Campinas
Country [49] 0 0
Brazil
State/province [49] 0 0
Goiania
Country [50] 0 0
Brazil
State/province [50] 0 0
Rio de Janeiro
Country [51] 0 0
Canada
State/province [51] 0 0
Alberta
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Manitoba
Country [54] 0 0
Canada
State/province [54] 0 0
Newfoundland and Labrador
Country [55] 0 0
Canada
State/province [55] 0 0
Ontario
Country [56] 0 0
Canada
State/province [56] 0 0
Quebec
Country [57] 0 0
Canada
State/province [57] 0 0
Saskatchewan
Country [58] 0 0
China
State/province [58] 0 0
Beijing
Country [59] 0 0
China
State/province [59] 0 0
Guangzhou
Country [60] 0 0
China
State/province [60] 0 0
Hefei Anhui
Country [61] 0 0
China
State/province [61] 0 0
Jinan
Country [62] 0 0
China
State/province [62] 0 0
Shanghai
Country [63] 0 0
Costa Rica
State/province [63] 0 0
San Jose
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Hradec Kralove
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Praha
Country [66] 0 0
Denmark
State/province [66] 0 0
Hellerup
Country [67] 0 0
Finland
State/province [67] 0 0
Helsinki
Country [68] 0 0
Finland
State/province [68] 0 0
Jyväskylä
Country [69] 0 0
France
State/province [69] 0 0
Amiens
Country [70] 0 0
France
State/province [70] 0 0
Bordeaux
Country [71] 0 0
France
State/province [71] 0 0
Boulogne-billancourt
Country [72] 0 0
France
State/province [72] 0 0
Brest
Country [73] 0 0
France
State/province [73] 0 0
Grenoble
Country [74] 0 0
France
State/province [74] 0 0
Le Kremlin-bicetre
Country [75] 0 0
France
State/province [75] 0 0
Lille
Country [76] 0 0
France
State/province [76] 0 0
Lyon
Country [77] 0 0
France
State/province [77] 0 0
Marseille
Country [78] 0 0
France
State/province [78] 0 0
Montpellier
Country [79] 0 0
France
State/province [79] 0 0
Nantes
Country [80] 0 0
France
State/province [80] 0 0
Nice
Country [81] 0 0
France
State/province [81] 0 0
Paris
Country [82] 0 0
France
State/province [82] 0 0
Pierre Benite
Country [83] 0 0
France
State/province [83] 0 0
Rennes
Country [84] 0 0
France
State/province [84] 0 0
Rouen
Country [85] 0 0
France
State/province [85] 0 0
St Priest En Jarez
Country [86] 0 0
France
State/province [86] 0 0
Strasbourg
Country [87] 0 0
France
State/province [87] 0 0
Toulouse
Country [88] 0 0
Germany
State/province [88] 0 0
Aachen
Country [89] 0 0
Germany
State/province [89] 0 0
Berlin
Country [90] 0 0
Germany
State/province [90] 0 0
Dresden
Country [91] 0 0
Germany
State/province [91] 0 0
Essen
Country [92] 0 0
Germany
State/province [92] 0 0
Gommern
Country [93] 0 0
Germany
State/province [93] 0 0
Herne
Country [94] 0 0
Germany
State/province [94] 0 0
Hildesheim
Country [95] 0 0
Germany
State/province [95] 0 0
Köln
Country [96] 0 0
Germany
State/province [96] 0 0
München
Country [97] 0 0
Germany
State/province [97] 0 0
Osnabrück
Country [98] 0 0
Germany
State/province [98] 0 0
Sendenhorst
Country [99] 0 0
Germany
State/province [99] 0 0
Wiesbaden
Country [100] 0 0
Germany
State/province [100] 0 0
Wuerzburg
Country [101] 0 0
Hong Kong
State/province [101] 0 0
Hong Kong
Country [102] 0 0
Hong Kong
State/province [102] 0 0
Tuen Mun
Country [103] 0 0
Iceland
State/province [103] 0 0
Reykjavik
Country [104] 0 0
Israel
State/province [104] 0 0
Ashkelon
Country [105] 0 0
Israel
State/province [105] 0 0
Haifa
Country [106] 0 0
Israel
State/province [106] 0 0
Rishon Lezion
Country [107] 0 0
Italy
State/province [107] 0 0
Brescia
Country [108] 0 0
Italy
State/province [108] 0 0
Genova
Country [109] 0 0
Italy
State/province [109] 0 0
Milano
Country [110] 0 0
Italy
State/province [110] 0 0
Padova
Country [111] 0 0
Italy
State/province [111] 0 0
Pavia
Country [112] 0 0
Italy
State/province [112] 0 0
Pisa
Country [113] 0 0
Italy
State/province [113] 0 0
Siena
Country [114] 0 0
Italy
State/province [114] 0 0
Udine
Country [115] 0 0
Lithuania
State/province [115] 0 0
Kaunas
Country [116] 0 0
Lithuania
State/province [116] 0 0
Klaipeda
Country [117] 0 0
Lithuania
State/province [117] 0 0
Panevezys
Country [118] 0 0
Lithuania
State/province [118] 0 0
Siauliai
Country [119] 0 0
Lithuania
State/province [119] 0 0
Vilnius
Country [120] 0 0
Mexico
State/province [120] 0 0
Guadalajara
Country [121] 0 0
Mexico
State/province [121] 0 0
Leon
Country [122] 0 0
Mexico
State/province [122] 0 0
Mexico City
Country [123] 0 0
Mexico
State/province [123] 0 0
Tijuana
Country [124] 0 0
Netherlands
State/province [124] 0 0
Nijmegen
Country [125] 0 0
Norway
State/province [125] 0 0
Levanger
Country [126] 0 0
Norway
State/province [126] 0 0
Lillehammer
Country [127] 0 0
Panama
State/province [127] 0 0
Panama City
Country [128] 0 0
Peru
State/province [128] 0 0
Lima
Country [129] 0 0
Portugal
State/province [129] 0 0
Lisboa
Country [130] 0 0
Puerto Rico
State/province [130] 0 0
Ponce
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Moscow
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Ryazan
Country [133] 0 0
Russian Federation
State/province [133] 0 0
St Petersburg
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Tula
Country [135] 0 0
Serbia
State/province [135] 0 0
Belgrade
Country [136] 0 0
Serbia
State/province [136] 0 0
Niska Banja
Country [137] 0 0
Slovenia
State/province [137] 0 0
Ljubljana
Country [138] 0 0
Slovenia
State/province [138] 0 0
Maribor
Country [139] 0 0
South Africa
State/province [139] 0 0
Cape Town
Country [140] 0 0
South Africa
State/province [140] 0 0
Diepkloof
Country [141] 0 0
South Africa
State/province [141] 0 0
Durban
Country [142] 0 0
South Africa
State/province [142] 0 0
Pinelands
Country [143] 0 0
South Africa
State/province [143] 0 0
Pretoria
Country [144] 0 0
South Africa
State/province [144] 0 0
Radiokop
Country [145] 0 0
Spain
State/province [145] 0 0
Barakaldo
Country [146] 0 0
Spain
State/province [146] 0 0
Barcelona
Country [147] 0 0
Spain
State/province [147] 0 0
Madrid
Country [148] 0 0
Spain
State/province [148] 0 0
Malaga
Country [149] 0 0
Spain
State/province [149] 0 0
Pontevedra
Country [150] 0 0
Spain
State/province [150] 0 0
Santiago de Compostela
Country [151] 0 0
Sweden
State/province [151] 0 0
Stockholm
Country [152] 0 0
Sweden
State/province [152] 0 0
Umea
Country [153] 0 0
Switzerland
State/province [153] 0 0
Lausanne
Country [154] 0 0
Thailand
State/province [154] 0 0
Bangkok
Country [155] 0 0
Thailand
State/province [155] 0 0
Chiang Mai
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Basingstoke
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Birmingham
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Cannock
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Derby
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Leeds
Country [161] 0 0
United Kingdom
State/province [161] 0 0
London
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Manchester
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Middlesborough
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Newcastle Upon Tyne
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Oxford
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Southampton
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Stoke-on-trent

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

Ethics approval
Ethics application status

Summary
Brief summary
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.
Trial website
https://clinicaltrials.gov/study/NCT00720798
Trial related presentations / publications
Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00720798