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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01583374




Registration number
NCT01583374
Ethics application status
Date submitted
20/04/2012
Date registered
24/04/2012

Titles & IDs
Public title
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
Scientific title
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS
Secondary ID [1] 0 0
2011-001555-37
Secondary ID [2] 0 0
CC-10004-AS-001
Universal Trial Number (UTN)
Trial acronym
POSTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondyloarthritis 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
Treatment: Drugs - Apremilast tablet 20 mg
Treatment: Drugs - Apremilast tablet 30 mg BID
Treatment: Drugs - Placebo

Experimental: Apremilast 20 mg - Apremilast 20 mg was taken orally twice a day (BID)

Experimental: Apremilast 30 mg - Apremilast 30 mg was taken orally twice a day

Placebo comparator: Placebo - Identically matched placebo tablets were taken orally twice a day


Treatment: Drugs: Apremilast tablet 20 mg
Apremilast 20 mg was taken orally twice a day (BID)

Treatment: Drugs: Apremilast tablet 30 mg BID
Apremilast 30 mg was taken orally twice a day

Treatment: Drugs: Placebo
Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260
Timepoint [7] 0 0
Baseline to Week 104 and 260
Secondary outcome [8] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Timepoint [8] 0 0
From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm.
Secondary outcome [9] 0 0
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Timepoint [9] 0 0
Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks

Eligibility
Key inclusion criteria
* Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. At the completion of screening procedures, a documented diagnosis of definite active AS, as defined by the modified New York criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is = 4
* Total back pain is = 4
* On stable dose of AS medication (or lack of medication) prior to randomization and through week 24
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for AS

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 administering 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2018
Sample size
Target
Accrual to date
Final
490
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 0 0
Southern Clinical Research - Hobart
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment hospital [3] 0 0
Coastal Joint Care - Maroochydore
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
6849 - Perth
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Maryland
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Massachusetts
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Minnesota
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Wisconsin
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Austria
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Wien
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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Alberta
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Hostivice
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Czechia
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Pardubice
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Czechia
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Praha 11
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Czechia
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Praha 4
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Czechia
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Praha
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Czechia
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Sokolov
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Czechia
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Zlin
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Boulogne
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France
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Créteil
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France
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France
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Paris
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Germany
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Germany
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Frankfurt
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Hamburg
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Heidelberg
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Germany
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Herne
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Hungary
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Budapest
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Hungary
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Debrecen
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Kistarcsa
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Veszprém
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Netherlands
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Leiden
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Maastricht
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Bialystok
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Gdynia
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Torun
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Wroclaw
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Braila
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Bucharest
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Cluj-Napoca
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Galati
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Romania
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Iasi
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Smolensk
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Russian Federation
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Vladimir
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Slovakia
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Piestany
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Slovakia
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Poprad
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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Santiago de Compostela
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Sweden
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Malmö
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United Kingdom
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Barnsley
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United Kingdom
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Bath
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United Kingdom
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Leeds
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


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/NCT01583374