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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00721123




Registration number
NCT00721123
Ethics application status
Date submitted
22/07/2008
Date registered
23/07/2008
Date last updated
28/11/2013

Titles & IDs
Public title
A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis
Scientific title
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822
Secondary ID [1] 0 0
WA18695
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 - All participants received tocilizumab 8 mg/kg to a maximum of 800 mg, administered by intravenous (IV) infusion over one hour, every 4 weeks. Concomitant therapies were limited to dosage and administration constraints detailed in the protocol.


Treatment: Drugs: Tocilizumab
Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Event (AE) Summary Over Time
Timepoint [1] 0 0
through 264 Weeks
Primary outcome [2] 0 0
Summary Adverse Event Rates Over Time
Timepoint [2] 0 0
through 264 Weeks
Primary outcome [3] 0 0
Overall Death Rate Over Time
Timepoint [3] 0 0
through 264 Weeks
Secondary outcome [1] 0 0
Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks
Timepoint [1] 0 0
through 264 Weeks
Secondary outcome [2] 0 0
Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks
Timepoint [2] 0 0
through 264 Weeks
Secondary outcome [3] 0 0
Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks
Timepoint [3] 0 0
through 264 Weeks
Secondary outcome [4] 0 0
Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks
Timepoint [4] 0 0
through 264 Weeks
Secondary outcome [5] 0 0
Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks
Timepoint [5] 0 0
through 264 Weeks
Secondary outcome [6] 0 0
Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks
Timepoint [6] 0 0
through 264 Weeks
Secondary outcome [7] 0 0
Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks
Timepoint [7] 0 0
through 264 Weeks
Secondary outcome [8] 0 0
Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks
Timepoint [8] 0 0
through 264 Weeks
Secondary outcome [9] 0 0
Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks
Timepoint [9] 0 0
through 264 Weeks
Secondary outcome [10] 0 0
Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks
Timepoint [10] 0 0
through 264 Weeks

Eligibility
Key inclusion criteria
* Patients who have completed participation in the Phase III study WA17822 (NCT00106548) 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 WA17822.
* Treatment with intravenous (IV) gammaglobulin, plasmapheresis, or Prosorba column since the last administration of study drug in WA17822.
* Treatment with an anti-tumor necrosis factor or anti-interleukin-1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822.
* Previous treatment with any cell-depleting therapies.
* Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline.

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
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
538
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Maroochydore
Recruitment hospital [3] 0 0
- Shenton Park
Recruitment postcode(s) [1] 0 0
5041 - Adelaide
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Brazil
State/province [3] 0 0
Porto Alegre
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Varna
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Manitoba
Country [10] 0 0
Canada
State/province [10] 0 0
Newfoundland and Labrador
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
France
State/province [13] 0 0
Besancon
Country [14] 0 0
France
State/province [14] 0 0
Creteil
Country [15] 0 0
France
State/province [15] 0 0
Le Mans
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
Germany
State/province [17] 0 0
Bad Bramstedt
Country [18] 0 0
Germany
State/province [18] 0 0
Bad Nauheim
Country [19] 0 0
Germany
State/province [19] 0 0
Baden-baden
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Erlangen
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Germany
State/province [23] 0 0
Koeln
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Hong Kong
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Tuen Mun
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Debrecen
Country [28] 0 0
Hungary
State/province [28] 0 0
Pécs
Country [29] 0 0
Israel
State/province [29] 0 0
Beer Sheva
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Petach Tikva
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Aviv
Country [34] 0 0
Italy
State/province [34] 0 0
Cona (ferrara)
Country [35] 0 0
Italy
State/province [35] 0 0
Gazzi
Country [36] 0 0
Italy
State/province [36] 0 0
Palermo
Country [37] 0 0
Italy
State/province [37] 0 0
Siena
Country [38] 0 0
Italy
State/province [38] 0 0
Udine
Country [39] 0 0
Mexico
State/province [39] 0 0
Chihuahua
Country [40] 0 0
Mexico
State/province [40] 0 0
Guadalajara
Country [41] 0 0
Mexico
State/province [41] 0 0
Mexico City
Country [42] 0 0
Mexico
State/province [42] 0 0
Mexico
Country [43] 0 0
Mexico
State/province [43] 0 0
San Luis Potosi
Country [44] 0 0
Singapore
State/province [44] 0 0
Singapore
Country [45] 0 0
Slovakia
State/province [45] 0 0
Piestany
Country [46] 0 0
Switzerland
State/province [46] 0 0
Bern
Country [47] 0 0
Switzerland
State/province [47] 0 0
Lausanne
Country [48] 0 0
Thailand
State/province [48] 0 0
Bangkok
Country [49] 0 0
Thailand
State/province [49] 0 0
Chiang Mai

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, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.
Trial website
https://clinicaltrials.gov/study/NCT00721123
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/NCT00721123