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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01209689
Registration number
NCT01209689
Ethics application status
Date submitted
24/09/2010
Date registered
27/09/2010
Date last updated
17/01/2013
Titles & IDs
Public title
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy
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Scientific title
A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy
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Secondary ID [1]
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2009-017488-40
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Secondary ID [2]
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WA22908
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Tocilizumab 4 mg/kg - Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.
Experimental: Tocilizumab 8 mg/kg - Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
Placebo comparator: Placebo - Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12
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Assessment method [1]
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ASAS20 was defined as an improvement of = 20% and an absolute improvement of = 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index \[BASFI\] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index \[BASDAI\] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.
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Timepoint [1]
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Baseline to Week 12
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Eligibility
Key inclusion criteria
* Adult patients = 18 years of age.
* Ankylosing spondylitis as defined by the modified New York criteria for = 3 months prior to baseline.
* Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] = 4.0, spinal pain visual analog scale [VAS] = 40).
* Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs).
* Inadequate response to treatment with etanercept, infliximab, adalimumab, or golimumab because of inadequate efficacy.
* Tumor necrosis factor (TNF) antagonist therapy must have been discontinued at least 8 weeks prior to baseline (etanercept 4 weeks).
* Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline).
* Oral corticosteroids (= 10 mg/day prednisone or equivalent) and NSAIDs/cyclooxygenase-2 [COX-2] inhibitors must be at stable dose for at least 4 weeks prior to baseline.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization.
* Total ankylosis of spine (as determined by investigator).
* Inflammatory rheumatic disease other than ankylosing spondylitis.
* Active, acute uveitis at baseline.
* Previous treatment with tocilizumab.
* Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening.
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection.
* History of or currently active primary or secondary immunodeficiency.
* Body weight > 150 kg.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2010
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
113
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Heidelberg
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- Hobart
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- Sydney
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- Woodville
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3084 - Heidelberg
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7000 - Hobart
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2050 - Sydney
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment outside Australia
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Funding & Sponsors
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Name
Hoffmann-La Roche
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Summary
Brief summary
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients. This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.
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Trial website
https://clinicaltrials.gov/study/NCT01209689
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Trial related presentations / publications
Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.
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Public notes
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Contacts
Principal investigator
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01209689
Download to PDF