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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
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
Secondary ID [1] 0 0
2009-017488-40
Secondary ID [2] 0 0
WA22908
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12
Timepoint [1] 0 0
Baseline to Week 12

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.
Minimum age
18 Years
Maximum age
No limit
Sex
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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Heidelberg
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Florida
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Georgia
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Idaho
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Kansas
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Maryland
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Michigan
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New Jersey
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North Carolina
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Pennsylvania
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Texas
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Belgium
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Bruxelles
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Gent
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Kortrijk
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Liege
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Yvoir
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Brazil
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Cuiabá
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Brazil
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Goiania
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Sao Paulo
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São Paulo
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Plovdiv
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Sofia
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Ontario
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Hlucin
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Esbjerg
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Hellerup
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Torun
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Piestany
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Durban
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Pinelands
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South Africa
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Pretoria
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South Africa
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Stellenbosch
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Alcorcon
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Barcelona
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Madrid
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Oviedo
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Sabadell
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United Kingdom
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Basingstoke
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Bath
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Greenock
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Leeds
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London
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Salford
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Stoke-on-trent
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United Kingdom
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Wigan

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01209689
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.
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/NCT01209689