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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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/NCT00883753




Registration number
NCT00883753
Ethics application status
Date submitted
17/04/2009
Date registered
20/04/2009
Date last updated
6/08/2014

Titles & IDs
Public title
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
Scientific title
An Extension Phase of the Multi-National Open-Label Study (MA21573) 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 and/or Anti-TNF Therapy.
Secondary ID [1] 0 0
2008-006924-68
Secondary ID [2] 0 0
MA22460
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: tocilizumab - Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.


Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.
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) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
108 Weeks
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events Leading to Withdraw
Timepoint [1] 0 0
108 Weeks
Secondary outcome [2] 0 0
Time to Withdrawal Due to an Adverse Event (AE)
Timepoint [2] 0 0
108 Weeks
Secondary outcome [3] 0 0
Percentage of Participants With Discontinuation of Treatment Due to Any Cause
Timepoint [3] 0 0
108 Weeks
Secondary outcome [4] 0 0
Time to Discontinuation of Tocilizumab Treatment for Any Cause
Timepoint [4] 0 0
108 Weeks
Secondary outcome [5] 0 0
Percentage of Participants With Marked Lipid Abnormalities
Timepoint [5] 0 0
108 Weeks
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events (AEs) of Special Interest
Timepoint [6] 0 0
108 Weeks
Secondary outcome [7] 0 0
Percentage of Participants With ALT Elevations > 3*ULN
Timepoint [7] 0 0
108 Weeks
Secondary outcome [8] 0 0
Percentage of Participants With AST Elevations > 3*ULN
Timepoint [8] 0 0
108 Weeks
Secondary outcome [9] 0 0
Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study
Timepoint [9] 0 0
108 Weeks
Secondary outcome [10] 0 0
Number of Participants Categorized by Worst Value for AST (SGOT) During the Study
Timepoint [10] 0 0
108 Weeks
Secondary outcome [11] 0 0
Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study
Timepoint [11] 0 0
108 Weeks
Secondary outcome [12] 0 0
Number of Participants Categorized by Worst Value for Total Cholesterol During the Study
Timepoint [12] 0 0
108 Weeks
Secondary outcome [13] 0 0
Number of Participants Categorized by Worst Value for Neutrophil Count During the Study
Timepoint [13] 0 0
108 Weeks
Secondary outcome [14] 0 0
Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)
Timepoint [14] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [15] 0 0
Percentage of Participants With DAS28 Low Disease Activity
Timepoint [15] 0 0
Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [16] 0 0
Percentage of Participants With DAS28 Remission
Timepoint [16] 0 0
Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [17] 0 0
Change From Baseline in DAS28
Timepoint [17] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [18] 0 0
Change From Baseline in Tender Joint Count
Timepoint [18] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [19] 0 0
Change From Baseline in Swollen Joint Count
Timepoint [19] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [20] 0 0
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)
Timepoint [20] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [21] 0 0
Change From Baseline in Patient Global Assessment of Disease Activity VAS
Timepoint [21] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [22] 0 0
Change From Baseline in Physician Global Assessment of Disease Activity VAS
Timepoint [22] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [23] 0 0
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Timepoint [23] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [24] 0 0
Change From Baseline in C-Reactive Protein (CRP)
Timepoint [24] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [25] 0 0
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response
Timepoint [25] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [26] 0 0
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response
Timepoint [26] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [27] 0 0
Percentage of Participants With American College of Rheumatology 70 (ACR70) Response
Timepoint [27] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [28] 0 0
Percentage of Participants With American College of Rheumatology 90 (ACR90) Response
Timepoint [28] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [29] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response
Timepoint [29] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [30] 0 0
Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response
Timepoint [30] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [31] 0 0
Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission
Timepoint [31] 0 0
Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [32] 0 0
Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score
Timepoint [32] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [33] 0 0
Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score
Timepoint [33] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [34] 0 0
Change From Baseline in FACIT-Fatigue Score
Timepoint [34] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108

Eligibility
Key inclusion criteria
- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-as for MA21573.

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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
934
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,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
- Cairns
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 - Cairns
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
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Canada
State/province [7] 0 0
Saskatchewan
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Bruntal
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Ostrava
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Sokolov
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Uherske Hradiste
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Zlin
Country [14] 0 0
France
State/province [14] 0 0
Belfort
Country [15] 0 0
France
State/province [15] 0 0
Caen
Country [16] 0 0
France
State/province [16] 0 0
Cahors
Country [17] 0 0
France
State/province [17] 0 0
Corbeil-essonnes
Country [18] 0 0
France
State/province [18] 0 0
Dijon
Country [19] 0 0
France
State/province [19] 0 0
La Rochelle
Country [20] 0 0
France
State/province [20] 0 0
Lievin
Country [21] 0 0
France
State/province [21] 0 0
Lomme
Country [22] 0 0
France
State/province [22] 0 0
Lyon
Country [23] 0 0
France
State/province [23] 0 0
Marseille
Country [24] 0 0
France
State/province [24] 0 0
Montivilliers
Country [25] 0 0
France
State/province [25] 0 0
Montpellier
Country [26] 0 0
France
State/province [26] 0 0
Mulhouse
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Poitiers
Country [29] 0 0
France
State/province [29] 0 0
Reims
Country [30] 0 0
France
State/province [30] 0 0
Roubaix
Country [31] 0 0
France
State/province [31] 0 0
St Brieuc
Country [32] 0 0
France
State/province [32] 0 0
Strasbourg
Country [33] 0 0
France
State/province [33] 0 0
Toulouse
Country [34] 0 0
France
State/province [34] 0 0
Valence
Country [35] 0 0
France
State/province [35] 0 0
Valenciennes
Country [36] 0 0
Greece
State/province [36] 0 0
Heraklion
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Eger
Country [39] 0 0
Hungary
State/province [39] 0 0
Szeged
Country [40] 0 0
Hungary
State/province [40] 0 0
Veszprem
Country [41] 0 0
Italy
State/province [41] 0 0
Arenzano
Country [42] 0 0
Italy
State/province [42] 0 0
Legnano
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Modena
Country [45] 0 0
Italy
State/province [45] 0 0
Monserrato
Country [46] 0 0
Italy
State/province [46] 0 0
Novara
Country [47] 0 0
Italy
State/province [47] 0 0
Palermo
Country [48] 0 0
Italy
State/province [48] 0 0
Potenza
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
Country [50] 0 0
Italy
State/province [50] 0 0
Siena
Country [51] 0 0
Italy
State/province [51] 0 0
Varese
Country [52] 0 0
Netherlands
State/province [52] 0 0
'S Hertogenbosch
Country [53] 0 0
Netherlands
State/province [53] 0 0
Alkmaar
Country [54] 0 0
Netherlands
State/province [54] 0 0
Amsterdam
Country [55] 0 0
Netherlands
State/province [55] 0 0
Apeldoorn
Country [56] 0 0
Netherlands
State/province [56] 0 0
Arnhem
Country [57] 0 0
Netherlands
State/province [57] 0 0
Bergen Op Zoom
Country [58] 0 0
Netherlands
State/province [58] 0 0
Den Haag
Country [59] 0 0
Netherlands
State/province [59] 0 0
Den Helder
Country [60] 0 0
Netherlands
State/province [60] 0 0
Enschede
Country [61] 0 0
Netherlands
State/province [61] 0 0
Gouda
Country [62] 0 0
Netherlands
State/province [62] 0 0
Heerlen
Country [63] 0 0
Netherlands
State/province [63] 0 0
Hilversum
Country [64] 0 0
Netherlands
State/province [64] 0 0
Leeuwarden
Country [65] 0 0
Netherlands
State/province [65] 0 0
Nieuwegein
Country [66] 0 0
Netherlands
State/province [66] 0 0
Nijmegen
Country [67] 0 0
Netherlands
State/province [67] 0 0
Roosendaal
Country [68] 0 0
Netherlands
State/province [68] 0 0
Rotterdam
Country [69] 0 0
Netherlands
State/province [69] 0 0
Schiedam
Country [70] 0 0
Netherlands
State/province [70] 0 0
Spijkenisse
Country [71] 0 0
Netherlands
State/province [71] 0 0
Vlissingen
Country [72] 0 0
Poland
State/province [72] 0 0
Krakow
Country [73] 0 0
Poland
State/province [73] 0 0
Poznan
Country [74] 0 0
Poland
State/province [74] 0 0
Wroclaw
Country [75] 0 0
Portugal
State/province [75] 0 0
Almada
Country [76] 0 0
Portugal
State/province [76] 0 0
Coimbra
Country [77] 0 0
Portugal
State/province [77] 0 0
Lisboa
Country [78] 0 0
Portugal
State/province [78] 0 0
Porto
Country [79] 0 0
Romania
State/province [79] 0 0
Bucharest
Country [80] 0 0
Romania
State/province [80] 0 0
Cluj-napoca
Country [81] 0 0
Saudi Arabia
State/province [81] 0 0
Jeddah
Country [82] 0 0
Spain
State/province [82] 0 0
Alicante
Country [83] 0 0
Spain
State/province [83] 0 0
Barcelona
Country [84] 0 0
Spain
State/province [84] 0 0
La Coruña
Country [85] 0 0
Spain
State/province [85] 0 0
Las Palmas
Country [86] 0 0
Spain
State/province [86] 0 0
Tenerife
Country [87] 0 0
Spain
State/province [87] 0 0
Almeria
Country [88] 0 0
Spain
State/province [88] 0 0
Caceres
Country [89] 0 0
Spain
State/province [89] 0 0
Cordoba
Country [90] 0 0
Spain
State/province [90] 0 0
Granada
Country [91] 0 0
Spain
State/province [91] 0 0
Huesca
Country [92] 0 0
Spain
State/province [92] 0 0
Lugo
Country [93] 0 0
Spain
State/province [93] 0 0
Madrid
Country [94] 0 0
Spain
State/province [94] 0 0
Malaga
Country [95] 0 0
Spain
State/province [95] 0 0
Salamanca
Country [96] 0 0
Spain
State/province [96] 0 0
Sevilla
Country [97] 0 0
Spain
State/province [97] 0 0
Valencia
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Barnsley
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Basingstoke
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Bournemouth
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Brighton
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Burton on Trent
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Bury St Edmonds
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Cambridge
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Cardiff
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Chelmsford
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Dudley
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Eastbourne
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Gillingham
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Harrogate
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Ipswich
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Liverpool
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Llantrisant
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Londonderry
Country [115] 0 0
United Kingdom
State/province [115] 0 0
London
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Maidstone
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Middlesborough
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Newcastle Upon Tyne
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Nottingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Reading
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Salford
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Sheffield
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Southport
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Swindon
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Torquay
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Westcliffe-on-sea
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Wirral
Country [128] 0 0
United Kingdom
State/province [128] 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 study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00883753
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00883753