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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01307423




Registration number
NCT01307423
Ethics application status
Date submitted
29/11/2010
Date registered
2/03/2011

Titles & IDs
Public title
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
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 Who Have Not Been Previously Treated With Disease-modifying Antirheumatic Drugs
Secondary ID [1] 0 0
2010-020324-22
Secondary ID [2] 0 0
CC-10004-PSA-005
Universal Trial Number (UTN)
Trial acronym
PALACE4
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

Experimental: Apremilast 20mg - Apremilast 20mg twice daily, orally

Experimental: Apremilast 30mg - Apremilast 30mg twice daily, orally

Placebo comparator: Placebo + 20mg Apremilast - Placebo + 20mg Apremilast tablets administered twice daily

Placebo comparator: Placebo + 30mg Apremilast - Placebo + 30mg Apremilast tablets administered twice daily


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

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

Treatment: Drugs: Placebo
Placebo
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 to 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) After 16 Weeks of Treatment
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 36-item Short Form Health Survey (SF-36) Physical Functioning Domain 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 Participants 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 Disease Activity Score (DAS 28) 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 = 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score 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 a ACR 70 Response at Week 16
Timepoint [27] 0 0
Baseline and Week 16
Secondary outcome [28] 0 0
Percentage of Participants With a 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 With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 at Week 16
Timepoint [30] 0 0
Baseline and Week 16
Secondary outcome [31] 0 0
Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 at Week 16
Timepoint [31] 0 0
Baseline and Week 16
Secondary outcome [32] 0 0
Percentage of Participants Achieving a MASES Score of Zero at Week 24
Timepoint [32] 0 0
Baseline and Week 24
Secondary outcome [33] 0 0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24
Timepoint [33] 0 0
Baseline and 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-36v2 Physical Functioning Scale Score 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 Participants Assessment of Pain Using the Visual Analog Scale 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 Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by = 1 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 With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 at Week 52
Timepoint [49] 0 0
Baseline and Week 52
Secondary outcome [50] 0 0
Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 at Week 52
Timepoint [50] 0 0
Baseline and Week 52
Secondary outcome [51] 0 0
Number of Participants With Treatment Emergent Adverse Events During the Placebo Controlled Phase
Timepoint [51] 0 0
Week 0 to Week 16 for placebo participants who entered EE 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 Treatment Emergent Adverse Events During the Apremilast Exposure Period
Timepoint [52] 0 0
Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 168.93 weeks and 229.36 weeks for apremilast 30 mg BID

Eligibility
Key inclusion criteria
Subjects must satisfy the following criteria to be enrolled in the study:

1. Male or female, aged = 18 years at time of consent.
2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of = 3 months duration.
5. Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at time of screening.
6. Have = 3 swollen AND = 3 tender joints.
7. Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics)
8. Be receiving treatment on an outpatient basis.
9. If taking oral corticosteroids, must be on a stable dose of prednisone = 10 mg/day or equivalent for at least 1 month prior to screening.
10. If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 2 weeks prior to screening and until they have completed the Week 24 study visit.
11. Low potency topical corticosteroids (Appendix M or locally available equivalent) will be allowed as background therapy for treatment of psoriasis on the face, axillae and groin in accordance with the manufacturers' suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. A non-medicated skin emollient (eg, Eucerin cream) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to the clinic visit.
12. Meet the following laboratory criteria:

* White blood cell count = 3000/mm3 (= 3.0 x 109/L) and < 14,000/mm3 (< 14 x 109/L)
* Platelet count = 100,000/mm3 (= 100 x 109/L)
* Serum creatinine = 1.5 mg/dL(= 132.6 µmol/L)
* Aspartate aminotransferase/Serum glutamic oxaloacetic transaminase (AST/SGOT) and Alanine aminotransferase/Serum glutamic pyruvic transaminase (ALT/SGPT) = 2 x upper limit of normal (ULN)
* Total bilirubin = 2 mg/dL (= 34 µmol/L)
* Hemoglobin = 9 g/dL (= 5.6 mmol/L)
* Hemoglobin A1c = 9.0%
13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on IP and for at least 28 days after the last dose of IP.
14. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception while on investigational product (IP) and for at least 28 days after the last dose of IP: one highly effective form (ie, hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner) and one additional form (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane], diaphragm, sponge). If one highly effective form of contraception cannot be used, then 2 forms of barrier contraception must be used, ie, latex condom or any nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane) with either of the following: sponge with spermicide or diaphragm with spermicide.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
2. Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
3. Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening.
4. Pregnant or breast feeding.
5. History of allergy to any component of the IP.
6. Hepatitis B surface antigen positive at screening.
7. Hepatitis C antibody positive at screening.
8. AST/SGOT and/or ALT/SGPT > 1.5 x ULN and total bilirubin > ULN or albumin < lower limit of normal (LLN).
9. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
10. Active tuberculosis or a history of incompletely treated tuberculosis.
11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.
12. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
13. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.
14. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix).
15. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
16. Erythrodermic, guttate, or pustular psoriasis.
17. Topical therapy for psoriasis, except as noted in the Inclusion Criteria, within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin).
18. Rheumatic autoimmune disease other than PsA, including systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, or polymyositis.
19. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis (Appendix Q).
20. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease).
21. Prior use of disease modifying antirheumatic drugs (DMARDS; small molecules or biologics).
22. Use of the following systemic therapy(ies) within 4 weeks of randomization, including but not limited to corticosteroids (except as noted in inclusion criteria), oral retinoids and fumaric acid esters.
23. Use of phototherapy within 4 weeks of randomization (ie, UVB, PUVA).
24. Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20).
25. Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column within 6 months of baseline.
26. Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
27. Prior treatment with apremilast.
28. Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/ pharmacodynamic half lives, if known (whichever is longer).

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
9/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2017
Sample size
Target
Accrual to date
Final
529
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
Menzies Centre for Population Health Research - Hobart
Recruitment hospital [5] 0 0
Optimus Clinical Research Pty. Ltd - Kogarah
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville
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
7000 - Hobart
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
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
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United States of America
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Indiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Nebraska
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United States of America
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North Carolina
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Pennsylvania
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Tennessee
Country [15] 0 0
United States of America
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Texas
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United States of America
State/province [16] 0 0
Wisconsin
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Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
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Liège
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Bulgaria
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Plovdiv
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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
State/province [22] 0 0
British Columbia
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Canada
State/province [23] 0 0
Manitoba
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Canada
State/province [24] 0 0
Newfoundland and Labrador
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Saskatchewan
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Czechia
State/province [28] 0 0
Praha 11
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 4
Country [31] 0 0
Czechia
State/province [31] 0 0
Zlin
Country [32] 0 0
Estonia
State/province [32] 0 0
Tallinn
Country [33] 0 0
Estonia
State/province [33] 0 0
Tartu
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France
State/province [34] 0 0
Nantes Cedex 01
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France
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Nice
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France
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Paris Cedex 10
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France
State/province [37] 0 0
Paris
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Hungary
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Budapest
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Hungary
State/province [39] 0 0
Debrecen
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Hungary
State/province [40] 0 0
Kistarcsa
Country [41] 0 0
Hungary
State/province [41] 0 0
Mako
Country [42] 0 0
Hungary
State/province [42] 0 0
Szolnok
Country [43] 0 0
Italy
State/province [43] 0 0
Genova
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Italy
State/province [45] 0 0
Napoli
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Verona
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
DaeJeon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Incheon
Country [50] 0 0
Lithuania
State/province [50] 0 0
Siauliai
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New Zealand
State/province [51] 0 0
Hamilton
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New Zealand
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Takapuna
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New Zealand
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Timaru
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Poland
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Bialystok
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Poland
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Bydgoszcz
Country [56] 0 0
Poland
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Bytom
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Poland
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Gdynia
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Poland
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Katowice
Country [59] 0 0
Poland
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Lublin
Country [60] 0 0
Poland
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Poznan
Country [61] 0 0
Poland
State/province [61] 0 0
Warszawa
Country [62] 0 0
Poland
State/province [62] 0 0
Wroclaw
Country [63] 0 0
Romania
State/province [63] 0 0
Bucharest
Country [64] 0 0
Romania
State/province [64] 0 0
Cluj-Napoca
Country [65] 0 0
Romania
State/province [65] 0 0
Galati
Country [66] 0 0
Romania
State/province [66] 0 0
Iasi
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Kemerovo
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Kezch
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Krasnoyarsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Nizhniy Novgorod
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Novosibirsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Penza
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Smolensk
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Tomsk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Vladimir
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Voronezh
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
Taiwan
State/province [78] 0 0
Tapei
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Barnsley South Yorkshire
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Burslem
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Cannock
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Poole
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Southampton

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 not provided in https://clinicaltrials.gov/study/NCT01307423