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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01172938




Registration number
NCT01172938
Ethics application status
Date submitted
6/07/2010
Date registered
30/07/2010

Titles & IDs
Public title
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis
Secondary ID [1] 0 0
CC-10004-PSA-002
Universal Trial Number (UTN)
Trial acronym
PALACE-1
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apremilast 20mg
Treatment: Drugs - Apremilast 30mg
Treatment: Drugs - Placebo + 20 mg Apremilast
Treatment: Drugs - Placebo + 30 mg Apremilast

Experimental: Apremilast 20 mg - 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase

Experimental: Apremilast 30mg - 30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily

Placebo comparator: Placebo + 20 mg Apremilast - Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16

Placebo comparator: Placebo + 30 mg Apremilast - Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.


Treatment: Drugs: Apremilast 20mg
Apremilast 20 mg twice daily, orally

Treatment: Drugs: Apremilast 30mg
Apremilast 30 mg twice daily, orally

Treatment: Drugs: Placebo + 20 mg Apremilast
Placebo + 20 mg Apremilast

Treatment: Drugs: Placebo + 30 mg Apremilast
Placebo + 30 mg Apremilast
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Percentage of Participants With an ACR 20 Response at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Change From Baseline in Patient's Assessment of Pain at Week 16
Timepoint [6] 0 0
Baseline and Week 16
Secondary outcome [7] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Change From Baseline in Dactylitis Severity Score at Week 16
Timepoint [8] 0 0
Baseline and Week 16
Secondary outcome [9] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16
Timepoint [9] 0 0
Baseline and Week 16
Secondary outcome [10] 0 0
Change From Baseline in the Disease Activity Score (DAS28) at Week 16
Timepoint [10] 0 0
Baseline and Week 16
Secondary outcome [11] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16
Timepoint [11] 0 0
Baseline and Week 16
Secondary outcome [12] 0 0
Change From Baseline in SF-36 Physical Function at Week 24
Timepoint [12] 0 0
Baseline and Week 24
Secondary outcome [13] 0 0
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Change From Baseline in Patient's Assessment of Pain at Week 24
Timepoint [14] 0 0
Baseline and Week 24
Secondary outcome [15] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24
Timepoint [15] 0 0
Baseline and Week 24
Secondary outcome [16] 0 0
Change From Baseline in Dactylitis Severity Score at Week 24
Timepoint [16] 0 0
Baseline and Week 24
Secondary outcome [17] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
Timepoint [17] 0 0
Baseline and Week 24
Secondary outcome [18] 0 0
Change From Baseline in the Disease Activity Score (DAS28) at Week 24
Timepoint [18] 0 0
Baseline and Week 24
Secondary outcome [19] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
Timepoint [19] 0 0
Baseline and Week 24
Secondary outcome [20] 0 0
Percentage of Participants With MASES Improvement = 20% at Week 16
Timepoint [20] 0 0
Baseline and Week 16
Secondary outcome [21] 0 0
Percentage of Participants With Dactylitis Improvement = 1 Point at Week 16
Timepoint [21] 0 0
Baseline and Week 16
Secondary outcome [22] 0 0
Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16
Timepoint [22] 0 0
Baseline and Week 16
Secondary outcome [23] 0 0
Percentage of Participants With MASES Improvement = 20% at Week 24
Timepoint [23] 0 0
Baseline and Week 24
Secondary outcome [24] 0 0
Percentage of Participants With Dactylitis Improvement = 1 Point at Week 24
Timepoint [24] 0 0
Baseline and Week 24
Secondary outcome [25] 0 0
Percentage of Participants With Good or Moderate EULAR Response at Week 24
Timepoint [25] 0 0
Baseline and Week 24
Secondary outcome [26] 0 0
Percentage of Participants With a ACR 50 Response at Week 16
Timepoint [26] 0 0
Baseline and Week 16
Secondary outcome [27] 0 0
Percentage of Participants With an ACR 70 Response at Week 16
Timepoint [27] 0 0
Baseline and Week 16
Secondary outcome [28] 0 0
Percentage of Participants With an ACR 50 Response at Week 24
Timepoint [28] 0 0
Baseline and Week 24
Secondary outcome [29] 0 0
Percentage of Participants With a ACR 70 Response at Week 24
Timepoint [29] 0 0
Baseline and week 24
Secondary outcome [30] 0 0
Percentage of Participants Achieving a MASES Score of Zero at Week 16
Timepoint [30] 0 0
Week 16
Secondary outcome [31] 0 0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16
Timepoint [31] 0 0
Week 16
Secondary outcome [32] 0 0
Percentage of Participants Achieving a MASES Score of Zero at Week 24
Timepoint [32] 0 0
Week 24
Secondary outcome [33] 0 0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24
Timepoint [33] 0 0
Week 24
Secondary outcome [34] 0 0
Percentage of Participants With a ACR 20 Response at Week 52
Timepoint [34] 0 0
Baseline and Week 52
Secondary outcome [35] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52
Timepoint [35] 0 0
Baseline and Week 52
Secondary outcome [36] 0 0
Change From Baseline in the SF-36 Physical Functioning Domain at Week 52
Timepoint [36] 0 0
Baseline and Week 52
Secondary outcome [37] 0 0
Percentage of Participants With a Modified PsARC Response at Week 52
Timepoint [37] 0 0
Baseline and Week 52
Secondary outcome [38] 0 0
Change From Baseline in the Patient Assessment of Pain at Week 52
Timepoint [38] 0 0
Baseline and Week 52
Secondary outcome [39] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52
Timepoint [39] 0 0
Baseline and week 52
Secondary outcome [40] 0 0
Change From Baseline in the Dactylitis Severity Score at Week 52
Timepoint [40] 0 0
Baseline and Week 52
Secondary outcome [41] 0 0
Change From Baseline in the CDAI Score at Week 52
Timepoint [41] 0 0
Baseline and Week 52
Secondary outcome [42] 0 0
Change From Baseline in the DAS28 at Week 52
Timepoint [42] 0 0
Baseline and Week 52
Secondary outcome [43] 0 0
Change From Baseline in the FACIT-Fatigue Scale Score at Week 52
Timepoint [43] 0 0
Baseline and Week 52
Secondary outcome [44] 0 0
Percentage of Participants With MASES Improvement = 20% at Week 52
Timepoint [44] 0 0
Baseline and Week 52
Secondary outcome [45] 0 0
Percentage of Participants With Dactylitis Improvement = 1 Point at Week 52
Timepoint [45] 0 0
Baseline and Week 52
Secondary outcome [46] 0 0
Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52
Timepoint [46] 0 0
Baseline and Week 52
Secondary outcome [47] 0 0
Percentage of Participants With an ACR 50 Response at Week 52
Timepoint [47] 0 0
Baseline and Week 52
Secondary outcome [48] 0 0
Percentage of Participants With an ACR 70 Response at Week 52
Timepoint [48] 0 0
Baseline and Week 52
Secondary outcome [49] 0 0
Percentage of Participants Achieving a MASES Score of Zero at Week 52
Timepoint [49] 0 0
Week 52
Secondary outcome [50] 0 0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52
Timepoint [50] 0 0
Week 52
Secondary outcome [51] 0 0
Number of Participants With Adverse Events During the Placebo-Controlled Period
Timepoint [51] 0 0
Week 0 to Week 16 for placebo participants who entered early escape at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)
Secondary outcome [52] 0 0
Number of Participants With Adverse Events During the Apremilast-Exposure Period
Timepoint [52] 0 0
Baseline to Week 260; median total exposure to Apremilast was 170 weeks

Eligibility
Key inclusion criteria
* Males or females, aged = 18 years at time of consent.
* Have a diagnosis of Psoriatic Arthritis (PSA, by any criteria) of = 6 months duration.
* Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at time of screening.
* Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
* May not have axial involvement alone
* Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine
* Have = 3 swollen AND = 3 tender joints.
* Males & Females must use contraception
* Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breast feeding.
* History of allergy to any component of the investigational product.
* Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.
* Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker

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 assessing the outcomes
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
2/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/10/2016
Sample size
Target
Accrual to date
Final
504
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Eastern Health Clinical School - Box Hill
Recruitment hospital [3] 0 0
Repatriation General Hospital - Daws Park
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Emeritus Research - Malvern
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
5041 - Daws Park
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3145 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Austria
State/province [16] 0 0
Vienna
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Canada
State/province [18] 0 0
Newfoundland and Labrador
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Canada
State/province [21] 0 0
Saskatchewan
Country [22] 0 0
France
State/province [22] 0 0
Orleans
Country [23] 0 0
France
State/province [23] 0 0
Toulouse Cedex
Country [24] 0 0
Germany
State/province [24] 0 0
Duisburg
Country [25] 0 0
Germany
State/province [25] 0 0
Erlangen
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Herne
Country [28] 0 0
Germany
State/province [28] 0 0
München
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Hungary
State/province [30] 0 0
Szolnok
Country [31] 0 0
Hungary
State/province [31] 0 0
Veszprém
Country [32] 0 0
New Zealand
State/province [32] 0 0
Crofton Downs
Country [33] 0 0
New Zealand
State/province [33] 0 0
Hamilton
Country [34] 0 0
New Zealand
State/province [34] 0 0
New Zealand
Country [35] 0 0
New Zealand
State/province [35] 0 0
Rotorua
Country [36] 0 0
New Zealand
State/province [36] 0 0
Takapuna
Country [37] 0 0
New Zealand
State/province [37] 0 0
Timaru
Country [38] 0 0
Poland
State/province [38] 0 0
Bydgoszcz
Country [39] 0 0
Poland
State/province [39] 0 0
Gdynia
Country [40] 0 0
Poland
State/province [40] 0 0
Katowice
Country [41] 0 0
Poland
State/province [41] 0 0
Sopot
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Kemerovo
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Ryazan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Smolensk
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Vladimir
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Voronezh
Country [48] 0 0
South Africa
State/province [48] 0 0
Cape Town
Country [49] 0 0
South Africa
State/province [49] 0 0
Durban
Country [50] 0 0
South Africa
State/province [50] 0 0
Johannesburg
Country [51] 0 0
South Africa
State/province [51] 0 0
Pinelands
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Santander
Country [54] 0 0
Spain
State/province [54] 0 0
Santiago de Compostela
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Barnsley South Yorkshire
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Colchester
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Edmunds

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

TypeCitations or Other Details
Journal Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO,... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT01172938