Arthritis, PsoriaticREWARDNCT02875184
A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
An observational study of Arthritis, Psoriatic, run by Amgen at 21 sites in Netherlands.
Trial summary
This is a multicenter, prospective, non-interventional, observational single arm study. 100 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
- Arthritis, Psoriatic
- How many people
- 200 participants
- Where
- 21 sitesNetherlands
- Study dates
- 6 Mar 2017to 30 Jun 2022
- 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 psoriatic arthritis will be recruited. 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 with apremilast for psoriatic arthritis.
Who cannot join
- Refusal to participate in the study.
- Language barrier for completing the questionnaires.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Prior exposure to apremilast
- Initiation of apremilast treatment by a dermatologist for psoriasis
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Netherlands21 sites
Amphia
Breda, North Brabant, 4819 EV
Research Site
Breda, 4818 CK
Reumazorg ZWN
Goes, Zeeland, 4462 EV
Beatrix Ziekenhuis
Gorinchem, South Holland, 4204 AA
Research Site
Gorinchem, 4204 AA
Groene Hart Ziekenhuis
Gouda, South Holland, 2803 HH
Research Site
Gouda, 2803 HH
St. Jansdal
Harderwijk, Gelderland, 3844DG
Research Site
Harderwijk, 3844 DG
Elkerliek ziekenhuis
Helmond, North Brabant, 5707 HA
MC Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
Research Site
Leeuwarden, 8934 AD
Reumazorg ZWN
Lelystad/Emmeloord, Flevoland, 8233GT / 8303 BX
Reumazorg ZWN
Roosendaal, North Brabant, 4707 CH
Research Site
Roosendaal, 4707 CH
Erasmus MC
Rotterdam, South Holland, 3015 CE
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ
Research Site
Rotterdam, 3015 CE
Research Site
Rotterdam, 3079 DZ
Viecuri Medisch Centrum
Venlo, Limburg, 5912 BL
Research Site
Venlo, 5912 BL
About this study
Official title: Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
This is a multicenter, prospective, non-interventional, observational single arm study.
100 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 Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.
Read the detailed description
The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).
- Conditions
- Arthritis, Psoriatic
- Keywords
- Psoriatic Arthritis, Apremilast, CC-10004
- Medical subject headings
- Arthritis, Psoriatic
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 |
|---|---|---|
| Psoriatic arthritis patients treated with apremilast | Psoriatic arthritis patients who are treated with apremilast according to daily practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline
The HAQ is a general questionnaire to assess physical functioning.
Measured: Up to 24 months
Secondary outcomes (7)
Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point
PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.
Measured: Up to 24 months
Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points
The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.
Measured: Up to 24 months
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6
The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.
Measured: Up to 6 months
Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6
The DLQI is a dermatology specific Quality of Life instrument.
Measured: Up to 6 months
Change from Baseline in Short Form 36 (SF36) at 12 months
The SF-36v2® Health Survey measures functional health and well-being from the patients point of view. It can be used across age (18 and older), disease and treatments.
Measured: Up to 12 months
Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months
EQ-5D is a standard instrument to measure of health status.
Measured: Up to 12 months
Change from Baseline in visual analogue scales (VAS) at various time point
VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start6 Mar 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies 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
- 200 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
- NCT02875184
- Sponsor's protocol ID
- CC-10004-PSA-009
- Other IDs
- CC-10004-PSA-009-20200071
- Acronym
- REWARD
- Status last verified
- Oct 2023
- First submitted
- 18 Aug 2016
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
- ClinicalTrials.gov ID
- NCT02875184
- Acronym / sponsor ID
- REWARD / CC-10004-PSA-009
- Conditions
- Arthritis, Psoriatic
- Keywords
- Psoriatic Arthritis, Apremilast, CC-10004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Aug 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.
100 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 Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.
Detailed description
The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis patients treated with apremilast | – | –Psoriatic arthritis patients who are treated with apremilast according to daily 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 psoriatic arthritis will be recruited. 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 with apremilast for psoriatic arthritis.
Key exclusion criteria (6 listed)
- Refusal to participate in the study.
- Language barrier for completing the questionnaires.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Prior exposure to apremilast
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 a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline
Time frame: Up to 24 months
The HAQ is a general questionnaire to assess physical functioning.
7 secondary outcomes
Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point
Time frame: Up to 24 months
Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points
Time frame: Up to 24 months
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6
Time frame: Up to 6 months
Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6
Time frame: Up to 6 months
Change from Baseline in Short Form 36 (SF36) at 12 months
Time frame: Up to 12 months
Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months
Time frame: Up to 12 months
Change from Baseline in visual analogue scales (VAS) at various time point
Time frame: Up to 24 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 10 Oct 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Expanded Access for CC-100004Link 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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic, run by Amgen at 21 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 6 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.