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| ID | Type | Description | Link |
|---|---|---|---|
| CC-10004-PSA-009-20200071 | Other Identifier | Amgen |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriatic arthritis patients treated with apremilast | Psoriatic arthritis patients who are treated with apremilast according to daily practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points |
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Inclusion Criter
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reumazorg ZWN | Lelystad/Emmeloord | Flevoland | 8233GT / 8303 BX | Netherlands | ||
| St. Jansdal |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
| Expanded Access for CC-100004 | View source |
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The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions. |
| 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. | 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. | 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. | 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. | 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 | Up to 24 months |
| Harderwijk |
| Gelderland |
| 3844DG |
| Netherlands |
| Viecuri Medisch Centrum | Venlo | Limburg | 5912 BL | Netherlands |
| Amphia | Breda | North Brabant | 4819 EV | Netherlands |
| Elkerliek ziekenhuis | Helmond | North Brabant | 5707 HA | Netherlands |
| Reumazorg ZWN | Roosendaal | North Brabant | 4707 CH | Netherlands |
| MC Leeuwarden | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| Beatrix Ziekenhuis | Gorinchem | South Holland | 4204 AA | Netherlands |
| Groene Hart Ziekenhuis | Gouda | South Holland | 2803 HH | Netherlands |
| Erasmus MC | Rotterdam | South Holland | 3015 CE | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | South Holland | 3079 DZ | Netherlands |
| Reumazorg ZWN | Goes | Zeeland | 4462 EV | Netherlands |
| Research Site | Breda | 4818 CK | Netherlands |
| Research Site | Gorinchem | 4204 AA | Netherlands |
| Research Site | Gouda | 2803 HH | Netherlands |
| Research Site | Harderwijk | 3844 DG | Netherlands |
| Research Site | Leeuwarden | 8934 AD | Netherlands |
| Research Site | Roosendaal | 4707 CH | Netherlands |
| Research Site | Rotterdam | 3015 CE | Netherlands |
| Research Site | Rotterdam | 3079 DZ | Netherlands |
| Research Site | Venlo | 5912 BL | Netherlands |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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