Clinical Trial Results:
Evaluation of the clinical and echographic response to Apremilast through clinical evaluation and through a joint-periarticular-nail echographic index in patients with active psoriatic arthritis.
Summary
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EudraCT number |
2017-000901-19 |
Trial protocol |
ES |
Global end of trial date |
23 Sep 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2022
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First version publication date |
15 Dec 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PSA‐PI‐006421
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Juan José de agustín de Oro, Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR), 34 934893000,
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Scientific contact |
Juan José de agustín de Oro, Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR), 34 934894189/606245743,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jun 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Sep 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To obtain a 20% reduction in the echographic index at 12 months after the introduction of Apremilast in study patients
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Protection of trial subjects |
There is no need to have special measurements to protect patients in this assay, since no pain or stress is expected
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
26 Mar 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 46
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Worldwide total number of subjects |
46
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EEA total number of subjects |
46
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
46
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
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Pre-assignment
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Screening details |
The inclusion criteria are: -Adults ≥18 years old with Psoriatic Arthritis with involvement of the hands and /or feet with active clinical disease -Presenting >2 synovitis and >1 enthesis by ultrasound The exclusion criteria are: -Concomitant treatment with methotrexate or flunomide or other DMARS -Previous or current use of biologic therap | ||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
46 | ||||||||||||||||
Number of subjects completed |
46 | ||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
Arms
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Arm title
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Experimental | ||||||||||||||||
Arm description |
- | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Apremilast
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Investigational medicinal product code |
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Other name |
Otezla
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
30 mg capsules twice a day for 12 months
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
Adults ≥ 18 years old with Psoriatic Arthritis with involvement of the hands and /or feet with active clinical disease, presenting >2 synovitis and >1 enthesis by ultrasound | ||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full study
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All the patients who started the treatment are included
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
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Subject analysis set title |
Full study
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All the patients who started the treatment are included
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End point title |
Change in ultrasound index | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At 12 months after introduction of IMP
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Statistical analysis title |
Treatment | ||||||||||||
Comparison groups |
Experimental v Full study
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
Method |
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Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
-50
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-66 | ||||||||||||
upper limit |
-38.5 | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
End of study
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25
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Reporting groups
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Reporting group title |
Treatment group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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02 May 2018 |
Because recruitment is lower than expected, it is decided to include a new center (Hospital del Mar). |
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19 Jul 2019 |
The sample size was recalculated due to low recruitment (at that time, a total of 38 patients had been included). An effect of 5% (range of reduction between 15% and 25%) was assumed. The effect size 0.5 is reached with a deviation of 0.1 or greater. Therefore, it was decided that with a size of 45, results with significant values could be obtained. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |