PsoriasisAPRILNCT02652494
Observational Study of Apremilast in Patients With Psoriasis in The Netherlands
An observational study of Psoriasis, run by Amgen at 12 sites in Netherlands.
Trial summary
This is a multicenter, prospective, non-interventional, observational single arm study. Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 154 participants
- Where
- 12 sitesNetherlands
- Study dates
- 22 Feb 2016to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two hundred adult patients treated with apremilast for psoriasis in clinical practice. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.
Who may be able to join
- Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
- Patients starting treatment for psoriasis with apremilast in clinical practice.
Who cannot join
- Refusal to participate in the study.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Prior exposure to apremilast
- Psoriatic arthritis treated by a rheumatologist in the previous year
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites
Centrum Oosterwal
Alkmaar, North Holland, 1817 MS
Meander MC
Amsersfoort, Utrecht, 3813 TZ
Bravis Ziekenhuis
Bergen op Zoom, North Brabant, 4624 VT
Amphia
Breda, North Brabant, 4818 CK
Zorggroep Twente
Hengelo, Gelderland, 7555 DL
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM
Radboud UMC
Nijmegen, Gelderland, 6525 GL
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ
Zuyderland MC
Sittard, Limburg, 6162 BG
Antonius Ziekenhuis Sneek
Sneek, Provincie Friesland, 8601 DZ
TweeSteden Ziekenhuis
Tilburg, North Brabant, 5042 AD
Maxima MC
Veldhoven, North Brabant, 5504 DB
About this study
Official title: Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands
This is a multicenter, prospective, non-interventional, observational single arm study.
Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.
Read the detailed description
Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.
Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.
- Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
- Patients will be asked to complete the following questionnaires:
- DLQI
- TSQM
- EQ5D
- SF36- Itch Visual Analog Scale (VAS)
- WPAI Work Productivity and Activity Index
- Patient Benefit Index PBI
End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.
AE monitoring All patients will be monitored for adverse events throughout the study.
From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Observational, Apremilast, APRIL, Non-Interventional, The Netherlands
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Apremilast per daily clinical practice | Dutch patients receiving Apremilast according to daily clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points
The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.
Measured: Up to approximately 12 months
Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points
The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.
Measured: Up to approximately 12 months
Secondary outcomes (9)
Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment
The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.
Measured: Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey
The SF-36v2® Health Survey measures functional health and well-being from the patient's point of view. It can be used across age (18 and older), disease, and treatment group.
Measured: Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)
EQ-5D is a standardized instrument for use as a measure of health outcome in a wide range of health conditions and treatment
Measured: Up to approximately 12 months
Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)
Itch VAS is a simple assessment of the itch severity using a visual analogue scale
Measured: Up to approximately 12 months
Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment
PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and Severity Index).
Measured: Up to approximately 2 months
Changes in body surface area (BSA)at 6 and 12 months treatment
BSA (Body Surface Area): severity is defined by how much of the body surface area is affected.
Measured: Up to approximately 12 months
Changes in static physician global assessment (sPGA) at 6 and 12 months treatment
sPGA: assessment by physician to classify disease activity in a consistent manner
Measured: Up to approximately 12 months
Baseline characteristics of patients initiating apremilast treatment
Characteristics at baseline of patient initiating apremilast treatment
Measured: Up to approximately 1 month
Reasons for discontinuation of apremilast
Rate and reasons for discontinuation of apremilast within 12 months of start
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start22 Feb 2016
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652494
- Sponsor's protocol ID
- CC-10004-PSOR-014
- Acronym
- APRIL
- Status last verified
- Jul 2020
- First submitted
- 8 Jan 2016
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
van den Reek JMPA, van der Leest RJT, Thomas SE, Prevoo R, Plantenga ME, de Jong EMGJ. Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands. Adv Ther. 2024 Apr;41(4):1594-1605. doi: 10.1007/s12325-023-02759-9. Epub 2024 Feb 24.
PubMed 38402373
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands
- ClinicalTrials.gov ID
- NCT02652494
- Acronym / sponsor ID
- APRIL / CC-10004-PSOR-014
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Observational, Apremilast, APRIL, Non-Interventional, The Netherlands
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, non-interventional, observational single arm study.
Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.
Detailed description
Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.
Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.
- Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
- Patients will be asked to complete the following questionnaires:
- DLQI
- TSQM
- EQ5D
- SF36- Itch Visual Analog Scale (VAS)
- WPAI Work Productivity and Activity Index
- Patient Benefit Index PBI
End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.
AE monitoring All patients will be monitored for adverse events throughout the study.
From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Apremilast per daily clinical practice | – | –Dutch patients receiving Apremilast according to daily clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred adult patients treated with apremilast for psoriasis in clinical practice. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
- Patients starting treatment for psoriasis with apremilast in clinical practice.
Key exclusion criteria (5 listed)
- Refusal to participate in the study.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Prior exposure to apremilast
- Psoriatic arthritis treated by a rheumatologist in the previous year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points
Time frame: Up to approximately 12 months
The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.
Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points
Time frame: Up to approximately 12 months
The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.
9 secondary outcomes
Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment
Time frame: Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey
Time frame: Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)
Time frame: Up to approximately 12 months
Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)
Time frame: Up to approximately 12 months
Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment
Time frame: Up to approximately 2 months
Changes in body surface area (BSA)at 6 and 12 months treatment
Time frame: Up to approximately 12 months
Changes in static physician global assessment (sPGA) at 6 and 12 months treatment
Time frame: Up to approximately 12 months
Baseline characteristics of patients initiating apremilast treatment
Time frame: Up to approximately 1 month
Reasons for discontinuation of apremilast
Time frame: Up to approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 38402373van den Reek JMPA, van der Leest RJT, Thomas SE, Prevoo R, Plantenga ME, de Jong EMGJ. Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands. Adv Ther. 2024 Apr;41(4):1594-1605. doi: 10.1007/s12325-023-02759-9. Epub 2024 Feb 24.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Expanded Access for CC-10004Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Amgen at 12 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points (time frame: Up to approximately 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.